#  @AscendingBio AscendingBio
AscendingBio posts on X about $pdsb, $aqst, in the, study the most. They currently have [---] followers and [---] posts still getting attention that total [-----] engagements in the last [--] hours.
### Engagements: [-----] [#](/creator/twitter::1883175331747479552/interactions)

- [--] Week [------] +109%
- [--] Month [------] -6.80%
- [--] Months [-------] -4.60%
- [--] Year [-------] +4,796%
### Mentions: [--] [#](/creator/twitter::1883175331747479552/posts_active)

- [--] Week [--] +12%
- [--] Month [--] +32%
- [--] Months [---] +24%
- [--] Year [---] +48,800%
### Followers: [---] [#](/creator/twitter::1883175331747479552/followers)

- [--] Week [---] +2.20%
- [--] Month [---] +7.80%
- [--] Months [---] +110%
### CreatorRank: [-------] [#](/creator/twitter::1883175331747479552/influencer_rank)

### Social Influence
**Social category influence**
[stocks](/list/stocks) 40% [finance](/list/finance) 8% [technology brands](/list/technology-brands) 4% [countries](/list/countries) 3% [cryptocurrencies](/list/cryptocurrencies) 2% [financial services](/list/financial-services) 1% [social networks](/list/social-networks) 1%
**Social topic influence**
[$pdsb](/topic/$pdsb) #3, [$aqst](/topic/$aqst) #12, [in the](/topic/in-the) 19%, [study](/topic/study) 15%, [$mrus](/topic/$mrus) #1, [$bcax](/topic/$bcax) #1, [$capr](/topic/$capr) 11%, [$spry](/topic/$spry) 10%, [$ocul](/topic/$ocul) #3, [company](/topic/company) 7%
**Top accounts mentioned or mentioned by**
[@thecellengineer](/creator/undefined) [@northernboston](/creator/undefined) [@jessiechimni](/creator/undefined) [@capybarareform](/creator/undefined) [@vieczny](/creator/undefined) [@octopusking77](/creator/undefined) [@richtrades100](/creator/undefined) [@jonnyfunguy](/creator/undefined) [@jfais20](/creator/undefined) [@psaibuhr](/creator/undefined) [@taintslapp12283](/creator/undefined) [@zipjet](/creator/undefined) [@adam7477882377](/creator/undefined) [@tradernorway](/creator/undefined)
**Top assets mentioned**
[Merus N.V. Common Shares (MRUS)](/topic/$mrus) [Bicara Therapeutics Inc. (BCAX)](/topic/$bcax) [ARS Pharmaceuticals, Inc. (SPRY)](/topic/$spry) [Ocular Therapeutix, Inc. (OCUL)](/topic/$ocul) [Nuvectis Pharma, Inc. (NVCT)](/topic/$nvct) [Sarepta Therapeutics, Inc. (SRPT)](/topic/$srpt) [Iovance Biotherapeutics, Inc. Common Stock (IOVA)](/topic/$iova) [SuperRare (RARE)](/topic/$rare) [Kyverna Therapeutics, Inc. (KYTX)](/topic/$kytx) [MDxHealth SA (MDXH)](/topic/$mdxh) [Nkarta, Inc. (NKTX)](/topic/$nktx) [Day One Biopharmaceuticals, Inc. (DAWN)](/topic/$dawn)
### Top Social Posts
Top posts by engagements in the last [--] hours
"$PDSB $MRUS $BCAX [--] Head & Neck Cancer Groups: 1) HPV Negative 2) HPV16 Positive 3) HPV Positive but not HPV16 Some companies have been slow to recognize that there are three distinct Head and Neck Cancer groups. All seem to recognize the difference between HPV negative and HPV positive cancer. HPV negative cancer often has its origin from smoking. The tumors typically include keratin a tough and fibrous protein which gives the tumor a hard and warty appearance. HPV negative patients tend to be older than those with HPV positive cancer. What some tend to miss is that it is wise to break the"
[X Link](https://x.com/anyuser/status/1933215870760685671) 2025-06-12T17:32Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Proportion HPV + or HPV - (Part 3) In two prior posts I sought to get a better understanding of the ratio of HPV positive to HPV negative head and neck cancer patients. Kevin Harrington from The Institute of Cancer Research - United Kingdom offered some estimates this week. He presented the prevalence rates of those with head and neck cancer who have experienced relapse/metastasis (r/m) as being similar for the HPV negative and the HPV16 groups. His chart suggests the HPV negative group is probably just a tad smaller. In the 2030s it is projected that UK and US prevalence"
[X Link](https://x.com/anyuser/status/1935724148384313686) 2025-06-19T15:39Z [---] followers, [----] engagements
"$AQST Well Written Article: https://www.allergicliving.com/2026/02/09/ceo-sees-clear-path-ahead-after-fda-rejects-anaphylm-epi-film/ https://www.allergicliving.com/2026/02/09/ceo-sees-clear-path-ahead-after-fda-rejects-anaphylm-epi-film/"
[X Link](https://x.com/AscendingBio/status/2022402204813115591) 2026-02-13T20:07Z [---] followers, [---] engagements
"$OCUL DATA RELEASE: Tuesday February [--] [----] at 8:00 AM ET https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-announce-topline-data-sol-1-phase-3 https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-announce-topline-data-sol-1-phase-3"
[X Link](https://x.com/anyuser/status/2022431178670973289) 2026-02-13T22:02Z [---] followers, [----] engagements
"$OCUL At JP Morgan today the CEO of Eyepoint seemed to spend most of his presentation acting like Ocular Therapeutix is not a significant competitor in the Wet AMD market. When asked specifically about the upcoming release of SOL-1 data he stated: "So at a high level I think we already know this TKIs work. There's been to my knowledge now [--] TKI trials with various delivery systems intravitreal orally suprachoroidal in wet AMD and they've all been positive. And so I do expect this study to show a positive benefit of TKIs." https://twitter.com/i/web/status/2011156374944956577"
[X Link](https://x.com/AscendingBio/status/2011156374944956577) 2026-01-13T19:20Z [---] followers, [----] engagements
"$AQST Buyout Talk - Sorry Waiting Required When Anaphylm approval happens I expect to hear significant buyout speculation. I have previously asserted that a buyout is unlikely until more is known about the efficacy of AQST-108 topical gel. Variations of that product might produce more revenue than Anaphylm. Dan made a statement on the call this week that many likely missed. He declared that they would be continuing work on AQST-108 this year because they need to make sure and understand the long-term value of this product. Understanding the efficacy of AQST-108 is going to take significant"
[X Link](https://x.com/AscendingBio/status/2019807186948366685) 2026-02-06T16:15Z [---] followers, [----] engagements
"$OCUL Saw where they listed new job openings today on Linkedin. Hmmm (9 jobs added in last [--] hours. Pure speculation about what this means. Yet gets my attention)"
[X Link](https://x.com/AscendingBio/status/2022438601737613510) 2026-02-13T22:31Z [---] followers, [----] engagements
"$OCUL What to Look for with SOL-1 Results: On Tuesday we will get the topline results from the SOL-1 (Phase [--] wet AMD) study for AXPAXLI. It is comparing a single AXPAXLI injection to a single Aflibercept (2 mg) injection. The key question to be answered is: How long does each drug last With topline results we will need to see how detailed they get with the results. I expect a measure of the statistical significance of the differences between the two groups. I am anticipating this to be a strong number. This may be based on comparing the number of rescues in each group. The main focus will be"
[X Link](https://x.com/AscendingBio/status/2022735141446299935) 2026-02-14T18:10Z [---] followers, [----] engagements
"$NVCT NXP900 Phase 1b Trial This study of NXP900 has [--] arms including both monotherapy and combination groups. The combo groups have less restrictive enrollment requirements. It is difficult at this point to determine the enrollment rate for each arm. However they anticipate that there will be multiple readouts in [----]. The earliest could happen in 2Q [----]. https://twitter.com/i/web/status/1995857120860705133 https://twitter.com/i/web/status/1995857120860705133"
[X Link](https://x.com/AscendingBio/status/1995857120860705133) 2025-12-02T14:06Z [---] followers, [---] engagements
"$NVCT Initiation of the Phase 1b Study of NXP900 -They are done with the dose escalation of NXP900 alone. A dose has been selected. -Now they begin a combo study NXP900 with osimertinib (EGFR Inhibitor). -Participants with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer (NSCLC) -Only [--] treatment locations. Yet these are top level sites in the US and UK who have high volume: Mayo Clinic MD Anderson . . . -They indicate to expect updates in [----]. I presume the first update may be focused on safety data. Maybe in late [----] we get some early efficacy results"
[X Link](https://x.com/AscendingBio/status/2001331972203745680) 2025-12-17T16:41Z [---] followers, [---] engagements
"$ABEO sold rights to TSHA-102 a gene therapy for Rett's Syndrome in exchange for royalties and milestone payments. First Patient Announced Today: https://ir.tayshagtx.com/news-releases/news-release-details/taysha-gene-therapies-announces-progress-across-tsha-102-pivotal https://ir.tayshagtx.com/news-releases/news-release-details/taysha-gene-therapies-announces-progress-across-tsha-102-pivotal"
[X Link](https://x.com/AscendingBio/status/2008622794267910147) 2026-01-06T19:32Z [---] followers, [----] engagements
"$MDXH Genomic Prostate Score (GPS) test to be used in key study. https://mdxhealth.com/press_release/mdxhealth-and-university-of-oxford-to-validate-gps-test-in-largest-randomized-trial-of-treatment-effectiveness-in-patients-with-localized-prostate-cancer/ https://mdxhealth.com/press_release/mdxhealth-and-university-of-oxford-to-validate-gps-test-in-largest-randomized-trial-of-treatment-effectiveness-in-patients-with-localized-prostate-cancer/"
[X Link](https://x.com/AscendingBio/status/2008911603106717785) 2026-01-07T14:40Z [---] followers, [---] engagements
"It seems I learn about a new cell therapy company every day. It is clear that many of these companies are not going to make it with such intense competition. My favorite right now is $FATE but I am always looking to challenge my assumptions. What is distinctive about $NKTX They appear to require lymphodepleting chemo. I am not able to find any outcome data to date. https://twitter.com/i/web/status/2014742092774260805 https://twitter.com/i/web/status/2014742092774260805"
[X Link](https://x.com/AscendingBio/status/2014742092774260805) 2026-01-23T16:48Z [---] followers, [---] engagements
"$CRDF The limited data presented today just prompts more questions than answers. This data is not mature enough to reach conclusions about the PFS results. I really liked the depth of response shown in the spider plots during the last data release. The lack of charts and graphs in today's presentation was disappointing. In summary I need to see more. Some of what I need to see requires at least another [--] months of data collection. When you are adding to an established standard of care that often prompts an initial response you should not rush the outcome data. This is an easy drug to add to"
[X Link](https://x.com/AscendingBio/status/2016157413661880596) 2026-01-27T14:32Z [---] followers, [----] engagements
"If you look at their phase [--] lung data that was released in January is does show some encouraging Overall Survival Data: median OS [----] vs [----] months. Yet there is none of the traditional information about tumor status. Instead they focus on absolute lymphocyte count (ALC). So these are not bad results. They just omit traditional data. Also the results suggest a step forward rather than a cure for cancer. These positive results need to be tested versus a control group in the ongoing phase [--]. https://twitter.com/i/web/status/2017303868347134192"
[X Link](https://x.com/AscendingBio/status/2017303868347134192) 2026-01-30T18:28Z [---] followers, [--] engagements
"$AQST Monday Monday . . . It is that time of the day when any news becomes much less likely. Oh how many times I refreshed the Aquestive Press Release page today after market closing. Likely I will be doing that again on Monday morning. I do not read anything into this. Too little information to reach big conclusions. Time to Wait"
[X Link](https://x.com/AscendingBio/status/2017355108716073249) 2026-01-30T21:51Z [---] followers, [----] engagements
"I am not reading the $SPRY financials that way. Let's see what they report at the next quarterly but they are burning cash at a very high rate. They are a long way from being profitable. It appears they will not be profitable without a big increase in market share. So who knows what the future brings. Yet take a look a the most recent financials and explain what indicates they are "past that bleed." https://twitter.com/i/web/status/2017997581029130619 https://twitter.com/i/web/status/2017997581029130619"
[X Link](https://x.com/AscendingBio/status/2017997581029130619) 2026-02-01T16:24Z [---] followers, [---] engagements
"We lack enough information to make a well-informed guess. So let that set in before reading my next statement. I will say that the most likely result is $AQST reporting Monday during pre or post-market hours that they are still working with the FDA and the application remains under active review. So no real change from the current status"
[X Link](https://x.com/AscendingBio/status/2018009952942510286) 2026-02-01T17:14Z [---] followers, [----] engagements
"@JessieChimni @thecellengineer @Octopusking77 I confirm that about $FATE. Yet I think $ACET just started their phase [--] a couple of weeks ago. Correct me if I am missing something"
[X Link](https://x.com/AscendingBio/status/2018345448860270592) 2026-02-02T15:27Z [---] followers, [---] engagements
"@richtrades100 @Jonny_fun_guy For $SPRY the FDA decision only took [--] months after resubmit. Therefore we could see an $AQST approval in October. CRL is an easy fix"
[X Link](https://x.com/AscendingBio/status/2018351775862902942) 2026-02-02T15:52Z [---] followers, [---] engagements
"$OCUL Results Timing Yes I expected SOL-1 data sooner. That was just a guess. The timing released today is still reasonable. I do not see it as sending a message. So the only question now is do they release data the week of Feb [--] or do they wait until the week of Feb [--] to create more of a buzz at the Macula Society meeting. Key statement: "SOL-1 (Phase [--] wet AMD) superiority trial on track for topline data in the second half of February [----]. Week [--] results for the SOL-1 trial are expected to be presented at the 49th Macula Society Annual Meeting taking place between February [--] [--] 2026.""
[X Link](https://x.com/AscendingBio/status/2019409296123928833) 2026-02-05T13:54Z [---] followers, [----] engagements
"If you have not waited on edge for a conference data release checking to see the presentation time and the embargo rules you are not an experience biotech investor. Please provide one example of the SEC going after a company in this context. They might if the delay was something like six months to a year. This is a case of at most a few weeks"
[X Link](https://x.com/AscendingBio/status/2019434338572554545) 2026-02-05T15:34Z [---] followers, [---] engagements
"$DAWN Quarterly (& Annual) Feb [--] https://ir.dayonebio.com/news-releases/news-release-details/day-one-report-fourth-quarter-and-full-year-2025-financial https://ir.dayonebio.com/news-releases/news-release-details/day-one-report-fourth-quarter-and-full-year-2025-financial"
[X Link](https://x.com/AscendingBio/status/2021226288250331337) 2026-02-10T14:14Z [---] followers, [---] engagements
"$PDSB $MRUS $BCAX Head & Neck Cancer Treatment This is an document where the focus is the patient perspective yet many investors will find this content helpful. https://twitter.com/i/web/status/1961078189192585705 https://www.reddit.com/r/NewCancerTreatment/comments/1mcc1q8/a_basic_guide_to_new_treatments_for_head_and_neck/ https://twitter.com/i/web/status/1961078189192585705 https://www.reddit.com/r/NewCancerTreatment/comments/1mcc1q8/a_basic_guide_to_new_treatments_for_head_and_neck/"
[X Link](https://x.com/AscendingBio/status/1961078189192585705) 2025-08-28T14:47Z [---] followers, [----] engagements
"$NVCT Quarterly Update "Laying the groundwork for multiple potential data readouts in [----]. " "Our Phase 1b monotherapy study evaluating NXP900's clinical potential in several molecularly and histologically-defined target tumors and the combination study of NXP900 with osimertinib in patients with EGFR-mutated non-small cell lung cancer ("NSCLC") are enrolling patients. In addition a combination with lorlatinib in ALK-positive NSCLC is pending commencement." Corp Presentation states: "Multiple clinical data updates from the Phase 1b program from mid to YE 2026.""
[X Link](https://x.com/AscendingBio/status/2021595921050427549) 2026-02-11T14:43Z [---] followers, [---] engagements
"@jfais20 Strange comparison to make. $IOVA treatment centers need a surgery team ready to act fast. You are comparing that to cell therapy treatment centers"
[X Link](https://x.com/AscendingBio/status/2022372410800906371) 2026-02-13T18:08Z [---] followers, [---] engagements
"$AQST Summary of Current Status The FDA says that the drug works. The FDA Clinical Pharmacology team has given it the green light. The drug manufacturing is good. The FDA Chemistry Manufacturing and Controls team has given approval. The FDA Human Factors team wants to make sure the drug gets used correctly. They want to know more about the consequences of user errors like chewing the film or placing it on the top of the tongue. They want the package to be easy to open. Aquestive will run two quick studies. Yet the most important response will likely be to modify the packaging to make it a"
[X Link](https://x.com/AscendingBio/status/2018706619459117547) 2026-02-03T15:22Z [---] followers, [----] engagements
"$ABEO $RARE UX111 CMC Incomplete Response Letter Update (Feb [--] announced resubmit Feb [--] letter requesting more documentation.) "We had provided complete responses to each CRL item but now the FDA is requiring additional details within support of documentation on the CMC. CRL responses made and their impact. This information is typically provided during an inspection and we were prepared to do so but will now provide the support of documentation as a part of our BLA resubmission." "The list of issues on the CRL are known to both part to FDA and US. Obviously we have the same list but the"
[X Link](https://x.com/AscendingBio/status/2022345557428072674) 2026-02-13T16:22Z [---] followers, [---] engagements
"$OCUL Control Group Expectations I have been giving more thought about what to expect from the control group. Typically a single Aflibercept (2 mg) injection would be given every [--] months. Some activity of the medication probably extends for another month. When the potency of the medication gets lower that should trigger vision loss. Yet it could take an extended time for the vision loss to reach the rescue criteria in this study. My initial expectation was that there will be a large proportion of the control group that will need rescue at [--] months. Yet that may not be the case. It could take"
[X Link](https://x.com/AscendingBio/status/2023085119116808332) 2026-02-15T17:20Z [---] followers, [----] engagements
"They reported that one person was alive at [--] months. I am sure you are new to cancer treatment and do not mean to present false information. Please learn more about how to interpret cancer outcome data before posting content like this. This has not stunned the medical community. They would never jump to such a conclusion without better data. It will take more time before the data is available to judge these results. This CEO is a hype man. Follow the data wherever it leads not the hype. https://twitter.com/i/web/status/2015919451955175786 https://twitter.com/i/web/status/2015919451955175786"
[X Link](https://x.com/AscendingBio/status/2015919451955175786) 2026-01-26T22:47Z [---] followers, [---] engagements
"I aspire to identify stocks that can be purchased now and held for a year to achieve long term capital gains. I seek to identify stocks that will at least double in value. I encourage you to consider these stocks yet do your own research before investing"
[X Link](https://x.com/AscendingBio/status/1883191331008471053) 2025-01-25T16:32Z [---] followers, [----] engagements
"I now consider my purchase of $PDSB stock and holding it for [--] years to be a donation to life saving cancer research. There is a chance I realize a huge profit but regardless I have supported what is right and good. On days like today it is nice to feel good about something"
[X Link](https://x.com/AscendingBio/status/1894046096810254434) 2025-02-24T15:25Z [---] followers, [----] engagements
"Forward Thinking U.S. Patent $AQST had an interesting Patent accepted on 12/24/2024. It envisions devices worn by persons sending data to physicians with recommendations for personalized prescriptions which would be compounded using an automated system at an FDA authorized facility and sent to clients directly by the manufacturer. It includes individualized medications that use film technology. One example is those who have allergies to inactive ingredients in medications who need special formulations. This patent builds on several other patents they have filed detailing components of this"
[X Link](https://x.com/AscendingBio/status/1904911134626283557) 2025-03-26T14:59Z [---] followers, [---] engagements
"$AQST I saw a post elsewhere about the death of Dr. Stephen Paul Wargacki Chief Science Officer on March [--] [----]. He was promoted to that position last summer after many years with the company. Very Sad I know his family friends and coworkers are grieving his loss. He played a significant role in bringing Anaphylm to where it is today. I give thanks for all the good he brought to the world. I express sympathy to all those experiencing loss"
[X Link](https://x.com/AscendingBio/status/1909963316052533549) 2025-04-09T13:35Z [---] followers, [----] engagements
"$AQST Lessons from Neffy (version 2.0) (I recently obtained new information that required the revision of prior content.) One of the issues faced by Neffy when they sought FDA approval was demonstrating that careful consideration had been given to new problems that could emerge with the shift to a different mode of administration. A study was conducted to demonstrate that there were no significant differences in PK (blood concentration) and PD (heart rate and pulse) when participants had upper respiratory infections. At some point it was recognized that nasal congestion could impact"
[X Link](https://x.com/AscendingBio/status/1910448456373813252) 2025-04-10T21:43Z [---] followers, [----] engagements
"$SPRY $AQST ARS CEO Statement About Bracketing And Other Data During the 3/20/25 quarterly call the ARS CEO stated Neffy remains the only approved product to have generated anaphylaxis efficacy data in a clinical study to have met the bracketing criteria established by FDA for approval of all key pharmokinetic parameters to ensure safety and efficacy and to have data demonstrating that it is well tolerated in children down to 15kg body weight who account for almost half of the patients prescribed epinephrine. I begin by acknowledging that this statement is true. Yet it is a long conditional"
[X Link](https://x.com/AscendingBio/status/1916510093463490564) 2025-04-27T15:09Z [---] followers, [----] engagements
"$PDSB More treatment centers have been added for Phase [--] study. Hopefully we will see several more soon"
[X Link](https://x.com/AscendingBio/status/1917716203537129778) 2025-04-30T23:02Z [---] followers, [----] engagements
"$CAPR There is a common fundamental misunderstanding of FDA ADCOMs. They do not delay the process. They provide more opportunity for the company and advocacy groups to make their case. In the ones that I have observed members of the committee ask good questions and make wise statements. They express practical and complex views of issues. They push the FDA staff to make good decisions. Given the great safety data and the encouraging outcome data for this treatment this Adcom has great potential to provide additional support for approval"
[X Link](https://x.com/AscendingBio/status/1919466880126882120) 2025-05-05T18:59Z [---] followers, [----] engagements
"$CAPR $SRPT I have been critical of some of the decisions of Peter Marks. Yet these statements by Vinay Prasad are dangerous. This is not someone that should be in a position of leadership at the FDA"
[X Link](https://x.com/anyuser/status/1919814405249699931) 2025-05-06T17:59Z [---] followers, 16.4K engagements
"$CAPR FDA Process Update "Path has been smooth." "FDA has not fallen behind in any way." "No substantial issues." FDA site inspection "within next few weeks." Label discussion meeting is scheduled for later this Summer. No date set yet for meeting before Cellular Tissue and Gene Therapies Advisory Committee. $CAPR has conducted two mock ADCOMs. Result was "passed with flying colors." Clarified that measure: Left Ventricular Ejection Fraction (LVEF) is being treated as an "outcome measure" by FDA not as a "surrogate measure.""
[X Link](https://x.com/AscendingBio/status/1922403728688349437) 2025-05-13T21:29Z [---] followers, [----] engagements
"$AQST Back to Basics The basic case for $AQST is that Anaphylm has the data it needs to be approved by the FDA. A key component is the results from the oral allergen study that matches the design recommended to them by the FDA. (AQST had proposed a different study design but they adopted the FDA's design.) In the Neffy ADCOM many reviewers stated that evaluating Neffy was very difficult because they did not have this kind of data. It also has a product that offers portability that cannot be matched by any device-based competitor. If Anaphylm is approved and dominates the epinephrine rescue"
[X Link](https://x.com/AscendingBio/status/1924871889173811446) 2025-05-20T16:56Z [---] followers, [----] engagements
"$MRUS $PDSB Merus 5/22 Call There is excitement about the Petosemtamab phase [--] results that will be presented at ASCO. Merus released the highlights of these results on May [--]. In the conference call Merus claimed that Petosemtamab is "substantially derisked." They said it has a "high probablity of meeting the needs of the entire metastatic PDL-1 positive first line market." It appears they did not even collect data on the HPV16 status of their [--] HPV+ participants of the [--] total participants. I could not find any indication that they will do this in the phase [--]. I would not expect"
[X Link](https://x.com/anyuser/status/1926999461395341471) 2025-05-26T13:50Z [---] followers, [----] engagements
"$IOVA From tonight's presentation: Amtagvi patients are heavily pretreated patients. Most have at least [--] prior treatments. (We know from other cancer research that those who have had a significant number of prior treatments are less likely to respond to a new treatment.) There is still work to do to gain insights into which prior treatments impact the efficacy of Amtagvi"
[X Link](https://x.com/AscendingBio/status/1928973016983126330) 2025-06-01T00:33Z [---] followers, [----] engagements
"$AQST I am anticipating FDA acceptance of the Anaphylm NDA on approximately Tuesday June [--]. If I am correct that is about a week away. (For fun comment with the day you guess - sorry no prize - just a little playful fun) All that follow AQST closely likely expect the NDA to be accepted. I do not see them having problems with poor study design lack of safety data or lack of manufacturing documentation. Yet I still think seeing a specific PDUFA date will put this on the radar for some. I am one who periodically checks the PDUFA list and sometimes I follow with an investment. A recent example"
[X Link](https://x.com/AscendingBio/status/1929351742522605808) 2025-06-02T01:37Z [---] followers, [----] engagements
"$ABEO Lab Capacity All is progressing well with ZEVASKYN rollout. -There are about [---] patients in the US that they are targeting. It will be common for them to receive at least two treatments. Each treatment is [---] million. If they provide [--] treatments a month they will be profitable. (That is positive cash flow for [--] patients a year.) - The goal is [--] to [--] treatments in [----]. They are thinking [--] treatments in [----]. It seems they are being cautious with these numbers. -First treatment center online. Four more added very soon. -They will start with lab capacity of [--] treatments per month."
[X Link](https://x.com/AscendingBio/status/1930304447948763646) 2025-06-04T16:43Z [---] followers, [---] engagements
"$MREO $RARE Orbit study: Database locked at end of April (all at minimum of [--] months some up to [--] months) "Database cleaning could take up to [--] months." Cleaning started at end of April. "If we have not made an announcement the DMC has not met." Cosmic Study: "Data has been cleaned in parallel." Results with Cosmic will be available later than Orbit. Denise Scots-Knight CEO $MREO"
[X Link](https://x.com/anyuser/status/1930380983078949290) 2025-06-04T21:47Z [---] followers, 13.3K engagements
"$AQST Stock Price Up 40% in a Week Over a period of a week we have seen the stock price of $AQST go up $1.07 about a 40% rise. Clearly there is expectation of FDA action by next week to approve the application for Anaphylm. My assessment is that this stock should be at about $5 right now. At least $4 seems achievable with an FDA announcement. It may even reach that before the FDA announcement if word does not arrive until Wednesday or later. I do not claim to be gifted at short-term stock price prediction. Yet the momentum from the last week suggests this stock price has awakened as Anaphylm"
[X Link](https://x.com/AscendingBio/status/1931019638906782168) 2025-06-06T16:05Z [---] followers, [----] engagements
"$PDSB Circulating Tumor DNA (Part [--] -NAV DX) Some may observe that circulating tumor HPV DNA is a great measure for the research setting but it will probably not be practical for this test to be used in everyday clinical practice. The big surprise is that last year a company started making this test available in the US. Recently I have noticed persons on social media posting their test results to celebrate that no cancer was found in the bloodstream after finishing treatment. (See: The test is increasingly covered by insurance. For those without insurance the cash price is about $2200. It"
[X Link](https://x.com/AscendingBio/status/1933882078191378663) 2025-06-14T13:39Z [---] followers, [---] engagements
"$SRPT Ambulatory vs. Non-ambulatory On the call today it was reported that they have not seen this serious liver issue in ambulatory participants. The non-ambulatory group is one where there has been much more severe disease progression. The future of serving the non-ambulatory group is uncertain at this point. The use of Sirolimus for immunosuppression is being explored. This year those receiving Elevidys have been 70% Ambulatory and 30% Non-ambulatory. Since beginning the treatment the numbers are 85% Ambulatory and 15% Ambulatory. If they move to only Ambulatory there is still a"
[X Link](https://x.com/anyuser/status/1934595405418733797) 2025-06-16T12:54Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Kevin Harrington MBBS Ph.D.The Institute of Cancer Research United Kingdom Key Point from Dr. Harrington Presentation:"
[X Link](https://x.com/anyuser/status/1935020347172032830) 2025-06-17T17:02Z [---] followers, [----] engagements
"$PDSB FDA - Diagnostic Test Program The FDA request for $PDSB to work with them on a diagnostic test for HPV16 in tumors appears to be related to the program in the attached document. Here are a couple of key elements: "FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers should meet. Through this transparency FDA seeks to support better and more consistent performance of certain LDTs used to identify patients for treatment with certain oncology drug products resulting in better drug selection and"
[X Link](https://x.com/anyuser/status/1935355818536267834) 2025-06-18T15:15Z [---] followers, [----] engagements
"$CAPR The removal of Nicole Verdun MD at the FDA is a surprise. She certainly appeared to be a very accomplished scientist. I am not sure what the impact will be on FDA regulation of cell and gene therapies. Anybody who does is probably not talking publicly right now. Uncertainty has sparked after hours selling of $CAPR. At this stage of the process it is unlikely that there will be any changes in the key FDA staff relating directly to Deramiocel approval. Who is in this leadership role and why they are there will have an impact on future interactions with the FDA but likely minimal"
[X Link](https://x.com/AscendingBio/status/1935488148114473202) 2025-06-19T00:01Z [---] followers, [----] engagements
"$CAPR I have not read the full statnews article by Adam Feuerstein. There is no way I would give them $30 for the right to do so. I have found Adam Feuerstein to be an unreliable source in the past. Who on the inside with credible information would tell their story to StatNews and not the Washington Post or New York Times The part of the article I can read says that the ADCOM was cancelled because Prasad was skeptical of Deramiocel. If one is skeptical why cancel an ADCOM That does not make sense. I will reserve judgment until I hear about this from a source I consider reliable. When a story"
[X Link](https://x.com/AscendingBio/status/1936123729907453970) 2025-06-20T18:07Z [---] followers, [----] engagements
"$CAPR HOPE-2 Year [--] (Part 1) It took me some time but here is what I think the HOPE-2 press release results are saying: To measure motor function the study used a assessment designed for DMD patients called PUL v2.0 (Performance of the Upper Limb). It includes tasks like raising arms above the head stacking cans removing a lid from a container and tracing a path. "Treatment continued to slow skeletal muscle disease progression as measured by Performance of the Upper Limb (PUL v2.0) with patients experiencing a smaller average decline in the fourth year (0.6 points) compared to the first year"
[X Link](https://x.com/anyuser/status/1936421603895542189) 2025-06-21T13:51Z [---] followers, [----] engagements
"$CAPR Looking at LVEF in DMD Left ventricular ejection fraction (LVEF) evaluates how well the heart's main pumping chamber the left ventricle is functioning. LVEF values are reported as the percentage of blood pumped out of the left ventricle with each heartbeat. The normal range for LVEF is about 50-70%. When you have values below 50% it is common to use terms like heart failure and cardiomyopathy. The first graph below shows there is a strong relationship between a low LVEF percentage and death for those with DMD. It displays that those with a 35% LVEF have about a 50% chance of dying"
[X Link](https://x.com/AscendingBio/status/1937867820395622880) 2025-06-25T13:37Z [---] followers, [---] engagements
"$PDSB HPV Circulating Tumor DNA I recently encountered a study published in [----] that looked at Circulating Tumor DNA (ctDNA) prior to treatment for those with HPV positive cancer. A test of ctDNA looks at evidence of cancer activity in the bloodstream. The study used data collected at Dana-Farber Cancer Institute in Boston. Types of HPV The vast majority of those in this study had HPV DNA that was identified as HPV16 (n = [--] 88%). The others were: HPV-33 (n = [--] 8%) HPV-35 (n = [--] 2%) HPV-31 (n = [--] 1%) and HPV-18 (n = [--] 1%). This study confirms that a substantial majority of those with HPV"
[X Link](https://x.com/AscendingBio/status/1939760299693023520) 2025-06-30T18:57Z [---] followers, [---] engagements
"$CAPR HOPE-3 Misinformation There is a biotechtv video going around with a Jones Research Analyst where they take STAT News as a reliable source. Mistake #1 Then they say - we now know that the FDA is going to make $CAPR use HOPE-3 data for initial approval but this data lacks heart measures so it can only be approved on motor changes. Mistakes #2 & [--]. There are LVEF heart measures in HOPE-3. Yes they could have to use this data. However $CAPR has not been told that to date. Therefore they are speculating but conveying that view as fact. We are on our own here. We have to take the time to"
[X Link](https://x.com/AscendingBio/status/1940143012254032340) 2025-07-01T20:18Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Who is the Early Winner (Part 2) For Head and Neck cancer there are three distinct groups: 1) HPV negative 2) HPV16 3) HPV positive who are not HPV16 Within each of these groups there are three important subgroups: 1) CPS = [--] 2) CPS 1-19 3) CPS [--] We know from past studies that Keytruda tends to work better for those with high CPS scores. In the Keynote-048 Study Keytruda Alone CPS [--] Median Overall Survival: [----] months CPS 1-19 Median Overall Survival: [----] months CPS scores tend to be higher in the HPV positive group. About 5% of those with HPV positive cancer have CPS ="
[X Link](https://x.com/anyuser/status/1940776055565894130) 2025-07-03T14:14Z [---] followers, [----] engagements
"$PDSB Reflections on Today's News So we get news today that PDS01ADC appears to enhance the efficacy of a chemotherapy drug for those with tumors in the liver with a kind of cancer that is really hard to treat. It seems to do so without adding significant side effects. This is a result that will get the attention of big drug companies. They start thinking about the numbers if this was added to a substantial number of chemo treatments. They begin imagining Keytruda revenue numbers. Yet as I write this the stock is down 2%. Yes these results are not conclusive yet. We need to see some solid"
[X Link](https://x.com/AscendingBio/status/1943311482868936715) 2025-07-10T14:08Z [---] followers, [----] engagements
"$SRPT Report of LGMD Study Participant Death I have not seen a statement from the company yet about this death. They had indicated this liver issue was not thought to be a significant risk for LGMD treatment due to lower doses. This is tragic and makes it less likely that another company will quickly resume this research. Then there is the question about when $SRPT knew about this death. I will wait for the $SRPT statement but if they knew about this yesterday there should have been at least a statement that they are investigating a very serious health event related to a LGMD patient. I also"
[X Link](https://x.com/anyuser/status/1946023533118730725) 2025-07-18T01:45Z [---] followers, [----] engagements
"$SRPT Reflections on the Call Today I rarely praise analysts. Today many of them asked direct and strongly worded questions that held Doug accountable. Many of Doug's answers were not acceptable. The problematic responses centered around materiality and disclosure. I particularly appreciate analysts asking "How will events be disclosed in the future" Doug indicated that his duty to disclose is very different for clinical trials versus approved products. He indicated that it is fine to wait to report death events like this in scientific papers presented at research conferences. It appears he"
[X Link](https://x.com/AscendingBio/status/1946236356474347964) 2025-07-18T15:51Z [---] followers, [----] engagements
"$PDSB Versamune Prior to Cancer Diagnosis in High-Risk populations - New Clinical Trial There have been statements by some leaders in cancer treatment about the possibility of using Versamune HPV in persons who are at high risk for HPV16 cancer. The first step toward that becoming a reality is a new clinical trial for those with HIV and HPV16. Versamune HPV (PDS0101) generates killer and helper T-cells that go after HPV16 cancer. It is designed to generate T-cells to target E6 and E7 oncoproteins which play a key role in the cancer-causing activity of HPV16. It uses a cancer vaccine approach"
[X Link](https://x.com/AscendingBio/status/1952067439958573488) 2025-08-03T18:02Z [---] followers, [----] engagements
"$CAPR The return of Prasad does bring some unpredictability. Yet his successor might have been worse. Yes it is crazy weird to bring him back two weeks later. What changed These guys talk constantly about increasing transparency at the FDA while we are shielded from much of what is driving erratic personnel and drug decisions. Will Prasad [---] be more measured and cautious I do not have the answer. The next big thing is the type A meeting where $CAPR will make reasonable requests that the FDA should grant. I do not see any reason for that to not go well. We should have word on that very soon."
[X Link](https://x.com/AscendingBio/status/1954913717306462673) 2025-08-11T14:32Z [---] followers, [----] engagements
"$AQST Next Step - ADCOM Decision It is approaching time for the FDA to conduct a mid-cycle review. This is an internal FDA meeting. It is common at this meeting for a decision to be made about if an ADCOM will occur later in the process. This means that within the next month the company is likely to learn if the FDA plans an ADCOM. The actual ADCOM would not happen until later in the year - likely November. Personally I hope there is an ADCOM. Dan has been clear that he prefers an ADCOM"
[X Link](https://x.com/AscendingBio/status/1955256712216142156) 2025-08-12T13:15Z [---] followers, [---] engagements
"$AQST Pediatric Study PD Results The PD results were released today for the pediatric study. This data looks good. The blood pressure data is the most important. I like the shape of the curve. The degree that this matches the general rise and fall of the adult curve is encouraging. When two datasets look this similar it is because the dosage and absorption rate is quite consistent across medication administrations. Typically we do not see this kind of consistency with IM injections"
[X Link](https://x.com/AscendingBio/status/1955265411550773556) 2025-08-12T13:49Z [---] followers, [----] engagements
"$CAPR Type A Meeting I am expecting a press release on Monday about the results of the Type A meeting. If we do not hear from $CAPR soon I will conclude that the FDA did not provide clear guidance at this meeting and indicated that they would get back to them when they reach a decision. If FDA leadership is micromanaging review staff decisions there could be some delays. I remain confident in the strength of the data and await clarity about the next steps"
[X Link](https://x.com/AscendingBio/status/1956063763834265843) 2025-08-14T18:41Z [---] followers, [---] engagements
"$SPRY $AQST Looking Ahead The next few months are going to be interesting to watch $SPRY. The upcoming quarter should bring a robust increase in sales with the back-to-school push. In the chart below the last three values on the X axis are in the 3rd quarter. The growth is encouraging but these are still fairly modest numbers with each mark on the Y axis representing [----] units. This company is still a long way from being profitable. They also plan for significant advertising spending through early [----]. Their adverting is really good but it is expensive. If $SPRY had a clear path to keep"
[X Link](https://x.com/AscendingBio/status/1956367172282003573) 2025-08-15T14:47Z [---] followers, [----] engagements
"$AQST Fall in stock price may also be linked to $SPRY being granted FDA approval for young children. Again not a rational reason. That FDA approval is actually a positive sign of what $AQST can anticipate at the FDA"
[X Link](https://x.com/AscendingBio/status/1897406711704789215) 2025-03-05T21:59Z [---] followers, [---] engagements
"ARS Pharmaceuticals Announces FDA Approval of neffy [--] mg (epinephrine nasal spray) for Type I Allergic Reactions Including Anaphylaxis in Pediatric Patients Weighing [--] to [--] Kilograms - ARS Pharmaceuticals"
[X Link](https://x.com/AscendingBio/status/1897407337587204143) 2025-03-05T22:02Z [---] followers, [---] engagements
"$AQST $SPRY Other Nasal Sprays - Part [--] Another company that has worked on a epinephrine nasal spray is Nasus Pharma. They use a powder that is sprayed in the nose. An advantage is that a powder is more stable than a liquid. I am concerned that many consumers will not like the concept of putting a powder in the nose. (Yes the obvious humor can be found here with use of a white powder in the nose.) In their PK studies my evaluation is that a single dose in one nostril does not result in ample epinephrine in the bloodstream. Their PK numbers when a dose is administered to each nostril looks"
[X Link](https://x.com/AscendingBio/status/1927741337891188966) 2025-05-28T14:58Z [---] followers, [---] engagements
"@northernboston You speak of a paradigm shift with Neffy being the new global standard. Why are you pushing $SPRY hard without acknowledging the next paradigm shift that is likely to come early next year with $AQST getting approval for Anaphylm Needle-free is a great step forward. Yet the next wave is the device-free era. Neffy will have a product that costs much more to produce and that can not compete on portability. If people buy $SPRY with their eyes open to this reality that is great. Maybe they are convinced that Anaphylm will never be approved. I think that is silly but everyone needs"
[X Link](https://x.com/AscendingBio/status/1960746429464633601) 2025-08-27T16:49Z [---] followers, [---] engagements
"$MCRB My take: They think they can get more than what Nestle offered. We will see if they are right. My guess is they have made a counter offer to Nestle that is closer to [--] billion. Nestle initially responded by telling the press about the offer. They want stock holders to put pressure on Series so they do not have to raise their offer much. One problem with this approach from Nestle is that it tells other companies that the Nestle offer is serious and anything they offer needs to be higher. For the stock to crash like this you need to believe that the Series execs will mess up this"
[X Link](https://x.com/AscendingBio/status/1965463805397238242) 2025-09-09T17:14Z [---] followers, [---] engagements
"$GMAB $MRUS $BCAX $PDSB WHAT The $GMAB acquisition of $MRUS for $8B is really puzzling. $MRUS has a head and neck cancer drug with a mechanism that is focused on the HPV negative market. This market is shrinking due to lower smoking rates in the US and Europe. $BCAX has a drug for the HPV negative market that appears to have much better depth of response than the $MRUS drug. The flashy $MRUS ORR numbers are not likely to translate into an OS (Overall Survival) advantage over $BCAX. $BCAX seems to especially have an advantage for those with low CPS scores which is typical for the HPV negative"
[X Link](https://x.com/AscendingBio/status/1973064096242085908) 2025-09-30T16:35Z [---] followers, [---] engagements
"$PDSB $BCAX $JNJ At ESMO encouraging results were presented for use of Amivantamab for those with HPV negative cancer. In combines a EGFR and MET inhibitor with an immunotherapy. An announcement about phase [--] trials should come soon. "We reported data on two populations: the safety population of [--] patients who received at least [--] dose of the drug and the efficacy population of [--] patients who had at least [--] tumor assessments or had stopped treatment for any reason. The efficacy data relate only to that smaller subset of patients." Of the five cohorts in this study there appears to have been"
[X Link](https://x.com/AscendingBio/status/1980664783020986866) 2025-10-21T15:57Z [---] followers, [----] engagements
"$NVCT So the key poster released today has safety data for NXP900. My thoughts are that it appears the medication is tolerated quite well. The key goal was improve safety so that it looked like this while maintaining efficacy. So now we need confirmation of efficacy. The drug is likely to work best at part of a combo. Therefore it will also be important to eventually see safety and efficacy data when it is taken with a med like an EGFR inhibitor. https://nuvectis.com/wp-content/uploads/First-in-human-phase-1-trial-of-NXP900-in-patients-with-advanced-solid-tumors-AACR-2025.pdf"
[X Link](https://x.com/AscendingBio/status/1981429738930417765) 2025-10-23T18:37Z [---] followers, [---] engagements
"$NVCT Higher Res NXP900 posters and additional comments now available. https://nuvectis.com/press-release-view/i=158794 https://nuvectis.com/press-release-view/i=158794"
[X Link](https://x.com/AscendingBio/status/1982796545494806904) 2025-10-27T13:08Z [---] followers, [---] engagements
"$KYTX Phase [--] MG Results (n=6) https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-positive-interim-phase-2-data https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-positive-interim-phase-2-data"
[X Link](https://x.com/AscendingBio/status/1983506552293130268) 2025-10-29T12:09Z [---] followers, [---] engagements
"$NVCT Upcoming Event Dec [--] I am looking forward to this event. I expect to learn information that will aid interpretation of future results. https://nuvectis.com/press-release-view/i=159884 https://nuvectis.com/press-release-view/i=159884"
[X Link](https://x.com/AscendingBio/status/1993370941720809673) 2025-11-25T17:27Z [---] followers, [---] engagements
"$SPRY $AQST Pricing ARS reports that Neffy pricing in Germany and UK is two times the EpiPen price"
[X Link](https://x.com/AscendingBio/status/1996307825543246000) 2025-12-03T19:57Z [---] followers, [----] engagements
"$AQST $SPRY New York law expands definition of epi rescue meds to include Neffy and Anaphylm. https://www.healio.com/news/allergy-asthma/20251209/new-york-governor-signs-two-allergy-bills-into-law https://www.healio.com/news/allergy-asthma/20251209/new-york-governor-signs-two-allergy-bills-into-law"
[X Link](https://x.com/AscendingBio/status/1998808324196938208) 2025-12-10T17:33Z [---] followers, [---] engagements
"$AKBA Akebia Therapeutics Announces First Patient Dosed in Phase [--] Clinical Trial of Praliciguat for the Treatment of Focal Segmental Glomerulosclerosis (FSGS) https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-first-patient-dosed-phase-2 https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-first-patient-dosed-phase-2"
[X Link](https://x.com/AscendingBio/status/2008546745874268488) 2026-01-06T14:30Z [---] followers, [---] engagements
"$PDSB The key words from today's news: "Based on the dialogue we had with the agency in December we are confident that we have a pathway to potentially accelerate our regulatory submission"
[X Link](https://x.com/AscendingBio/status/2009647650380107825) 2026-01-09T15:25Z [---] followers, [----] engagements
"$KYTX $RNAC MG Data Statement When the green graphs below were shown today at the $KYTX presentation it was reported that no others have achieved this in MG. The second slide with red lines comes from a $RNAC study. The results look similar to me. There are plenty of problems with making these kinds of comparisons. Yet $RNAC is in phase [--] with this treatment. Their treatment is delivered in an outpatient setting without Lymphodepleting Chemotherapy. Yes it takes [--] doses but you do not need a hospital stay. This may lead to the first FDA approved autoimmune treatment without Lymphodepleting"
[X Link](https://x.com/AscendingBio/status/2011538840461214075) 2026-01-14T20:40Z [---] followers, [----] engagements
"$OCUL DATA TIME I know all the chatter is about a buyout. Where my attention is focused is on the data. It is data time There is a good chance we get results this week. (I am expecting results before February. We will see . . .)"
[X Link](https://x.com/AscendingBio/status/2013296844823044191) 2026-01-19T17:05Z [---] followers, [----] engagements
"$IBRX To make a smart investment in a stock like this. You need to: 1) Understand cancer research 2) Have knowledge of existing treatments 3) Understand FDA practices 4) Know what competitors are doing For example the FDA typically requires cancer drugs to have registrational studies where some of the participants are randomly assigned to a control group. Yes there are a few exceptions to this practice. Sometimes exceptions are granted for rare diseases. Occasionally single-arm studies are accepted when persons have exhausted all other treatment options and quick death is almost guaranteed."
[X Link](https://x.com/AscendingBio/status/2017272647915037012) 2026-01-30T16:24Z [---] followers, [----] engagements
"Look at the phase [--] lung cancer data they released this month. It shows some encouraging Overall Survival Data: median OS [----] vs [----] months. Yet there is none of the traditional information about tumor status. Instead they focus on absolute lymphocyte count (ALC). So these are not bad results. They just omit traditional data. Also the results suggest a step forward rather than a cure for cancer. These positive results need to be tested versus a control group in the ongoing phase [--]. Again I am encouraged by results like this. They just need to be interpreted with care."
[X Link](https://x.com/AscendingBio/status/2017307675311096144) 2026-01-30T18:43Z [---] followers, [--] engagements
"Yes for swallowing. They have hard data there that was posted about a year ago. I have not seen hard data for top of tongue but the tongue is highly vascular compared to many other tissues in the body. If these human factors folks at the FDA took a look at the science they would not make this request"
[X Link](https://x.com/AscendingBio/status/2018353307153031632) 2026-02-02T15:58Z [---] followers, [---] engagements
"$AQST Anaphylm FDA submission complete by 3/31. FDA has [--] days to consider acceptance of application followed by [--] days to send decision letter (74 days total). So answer before Friday June 13th. Letter contains PDUFA date"
[X Link](https://x.com/anyuser/status/1899204180285284817) 2025-03-10T21:02Z [---] followers, [---] engagements
"$AQST Bracketing & The FDA Anaphylm is being considered for FDA approval under the 505(b)(2) program which permits using preexisting data to approve the drug. Basically there is not a need to prove that Epinephrine is effective in treating allergic reactions. Anaphylm needs to show evidence that it delivers appropriate amounts of Epinephrine. A word that has frequently been used when evaluating the equivalence of new epinephrine rescue medications to existing ones is bracketing. When Neffy recently went through this process the FDA bracketing standard was never rigidly applied. It started"
[X Link](https://x.com/AscendingBio/status/1912124634993983942) 2025-04-15T12:43Z [---] followers, [----] engagements
"$ABEO Some Highlights of Today's Call -Three patients per month is break even. -Will begin serving patients soon - 3rd Quarter. Goal of [--] to [--] patients served by end of [----]. -One month lab shut down in December. -Announcement coming soon about plans to expand capacity of US lab. -They will begin working on access to markets outside US now. -The shelf life of the product is [--] hours. So it is challenging to manufacture in US and supply to markets far from US. Eventually will need to have lab outside US. -Last few priority vouchers have sold for about [---] million. They hope to negotiate a"
[X Link](https://x.com/AscendingBio/status/1917238925363421200) 2025-04-29T15:25Z [---] followers, [----] engagements
"$PDSB Very helpful information this morning that P16+ and HPV16 are different designations. HPV16+ is a subgroup of those said to be p16+. Those in the HPV16+ are the focus of PDSB research. It is group that is less response to Keytruda alone"
[X Link](https://x.com/AscendingBio/status/1925925682657341936) 2025-05-23T14:43Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Proportion HPV + or HPV - (Part 2) I have been trying to get a grasp on the numbers of HPV positive versus HPV negative Head and Neck Cancer patients. This is really difficult because the numbers are changing and vary dramatically based on country. Here are my efforts to sort out the proportions in the US. First my best estimate is that 70% of those in the US with Head and Neck Cancer are HPV +. This is what Grok said: "The proportion of HPV-positive head and neck cancers particularly OPSCC has been increasing over time. In the U.S. studies show a rise from 20.9% before 1990"
[X Link](https://x.com/anyuser/status/1934264320277233768) 2025-06-15T14:58Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Wake Up A Change Is Happening A key theme of the $PDSB Key Opinion Leader presentation yesterday was that change is happening yet some are slow to respond. Kevin Harrington reports that doctors like him that work with those who have Head and Neck cancer have observed a dramatic change over the past decade in the proportion of patients with HPV16 cancer. These are typically men. They tend to be younger than those with HPV negative cancer and have fewer other health problems. He hesitated to call this an epidemic but described it as a huge increase. Katharine A. Price who"
[X Link](https://x.com/anyuser/status/1935336654039851077) 2025-06-18T13:59Z [---] followers, [---] engagements
"$PDSB $MRUS $BCAX Who is the Early Winner (Part 3) Confirmed ORR Another way to compare Petosemtamab and Ficera is using confirmed Objective Response Rate (CORR) values. Petosemtamab CORR CPS [--] 73% CPS 1-19 47% Ficera CORR CPS [--] 53% CPS 1-19 54% This data indicates that we may find that Ficera works better for those with lower CPS scores. That is a big deal because CPS scores tend to be lower for those in the HPV negative group. Petosemtamab may be more effective for those with high CPS scores. However since Petosemtamab has both HPV + and HPV - patients mixed in their numbers and these are"
[X Link](https://x.com/anyuser/status/1942206736439320929) 2025-07-07T12:59Z [---] followers, [----] engagements
"If you look over the history of $PDSB you are going to have a really hard time finding a bad news event related to data. To my knowledge every study they have reported includes a good outcome. There was another good result last week. The stock price just does not match the data. Yes it takes more than data. Yet you do not find this kind of success after success without their being something of real substance there"
[X Link](https://x.com/AscendingBio/status/1945524917942063315) 2025-07-16T16:44Z [---] followers, [---] engagements
"$PDSB $MRUS $BCAX Important Head & Neck Cancer Clinical Trials I decided to take a closer look at the clinical trials for three drugs that reported strong data for head and neck cancer at ASC0 [----]. Part of my focus is considering the implications of the inclusion and exclusion criteria. Versamune HPV16 For those seeking to enter the Versamune trial they need to have no prior treatment with a checkpoint inhibitor like Keytruda. That makes sense since some will be assigned to the control group where Keytruda alone is the treatment. Most of those entering this trial will have received"
[X Link](https://x.com/anyuser/status/1949929705626570919) 2025-07-28T20:27Z [---] followers, [----] engagements
"$pdsb Quarterly Call -Reviewed recent study results that were previously reported -They continue to keep expenses relatively low There was no big news here. All is on track with phase [--] trial. They will submit phase [--] results for publication at the end of the year"
[X Link](https://x.com/anyuser/status/1955607646788341877) 2025-08-13T12:29Z [---] followers, [----] engagements
"$SPRY $AQST Neffy - Headaches I have posted before about seeing a number of reports of persons experiencing really bad headaches after using Neffy. I continue to see these reports. My best guess is that the issue here is the absorption technology not the Epinephrine. Other nasal strays that use this technology have reported similar side effects. I was reminded of this today when this issue appeared in an AI box when I did a search for Neffy on Reddit (see below). It is difficult to determine the prevalence of this issue. Yet it could be a factor in some moving to Anaphylm when it is approved."
[X Link](https://x.com/anyuser/status/1957096691741630545) 2025-08-17T15:06Z [---] followers, [----] engagements
"$PDSB It looks like PDSB just registered a shelf offering. This makes sense. It gives them flexibility to sell stock at a time they select. (They are not committed to sell all this stock.) Their current approach is to sell stock as needed to get through the phase [--] trial. They want to dilute as little as possible but fund this vital study. This lets them make small stock sales at opportune times"
[X Link](https://x.com/AscendingBio/status/1961553343639367941) 2025-08-29T22:15Z [---] followers, [----] engagements
"$CAPR The Current Status $CAPR had a type A meeting with the FDA where they were able to make an extensive presentation and suggest options for a path forward with Deramiocel. My speculation is that this was well received by the FDA staff. It appears that the FDA staff around the table have been supportive of approval of Deramiocel throughout this process. Yet I am not aware of any reports that Prasad was present at the type A meeting. So the person who overrode and fired staff who stood their ground in support of Deramiocel will likely need to weigh in for there to be any clarity. Presumably"
[X Link](https://x.com/anyuser/status/1962207083429781825) 2025-08-31T17:33Z [---] followers, [----] engagements
Limited data mode. Full metrics available with subscription: lunarcrush.com/pricing
@AscendingBio AscendingBioAscendingBio posts on X about $pdsb, $aqst, in the, study the most. They currently have [---] followers and [---] posts still getting attention that total [-----] engagements in the last [--] hours.
Social category influence stocks 40% finance 8% technology brands 4% countries 3% cryptocurrencies 2% financial services 1% social networks 1%
Social topic influence $pdsb #3, $aqst #12, in the 19%, study 15%, $mrus #1, $bcax #1, $capr 11%, $spry 10%, $ocul #3, company 7%
Top accounts mentioned or mentioned by @thecellengineer @northernboston @jessiechimni @capybarareform @vieczny @octopusking77 @richtrades100 @jonnyfunguy @jfais20 @psaibuhr @taintslapp12283 @zipjet @adam7477882377 @tradernorway
Top assets mentioned Merus N.V. Common Shares (MRUS) Bicara Therapeutics Inc. (BCAX) ARS Pharmaceuticals, Inc. (SPRY) Ocular Therapeutix, Inc. (OCUL) Nuvectis Pharma, Inc. (NVCT) Sarepta Therapeutics, Inc. (SRPT) Iovance Biotherapeutics, Inc. Common Stock (IOVA) SuperRare (RARE) Kyverna Therapeutics, Inc. (KYTX) MDxHealth SA (MDXH) Nkarta, Inc. (NKTX) Day One Biopharmaceuticals, Inc. (DAWN)
Top posts by engagements in the last [--] hours
"$PDSB $MRUS $BCAX [--] Head & Neck Cancer Groups: 1) HPV Negative 2) HPV16 Positive 3) HPV Positive but not HPV16 Some companies have been slow to recognize that there are three distinct Head and Neck Cancer groups. All seem to recognize the difference between HPV negative and HPV positive cancer. HPV negative cancer often has its origin from smoking. The tumors typically include keratin a tough and fibrous protein which gives the tumor a hard and warty appearance. HPV negative patients tend to be older than those with HPV positive cancer. What some tend to miss is that it is wise to break the"
X Link 2025-06-12T17:32Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Proportion HPV + or HPV - (Part 3) In two prior posts I sought to get a better understanding of the ratio of HPV positive to HPV negative head and neck cancer patients. Kevin Harrington from The Institute of Cancer Research - United Kingdom offered some estimates this week. He presented the prevalence rates of those with head and neck cancer who have experienced relapse/metastasis (r/m) as being similar for the HPV negative and the HPV16 groups. His chart suggests the HPV negative group is probably just a tad smaller. In the 2030s it is projected that UK and US prevalence"
X Link 2025-06-19T15:39Z [---] followers, [----] engagements
"$AQST Well Written Article: https://www.allergicliving.com/2026/02/09/ceo-sees-clear-path-ahead-after-fda-rejects-anaphylm-epi-film/ https://www.allergicliving.com/2026/02/09/ceo-sees-clear-path-ahead-after-fda-rejects-anaphylm-epi-film/"
X Link 2026-02-13T20:07Z [---] followers, [---] engagements
"$OCUL DATA RELEASE: Tuesday February [--] [----] at 8:00 AM ET https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-announce-topline-data-sol-1-phase-3 https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-announce-topline-data-sol-1-phase-3"
X Link 2026-02-13T22:02Z [---] followers, [----] engagements
"$OCUL At JP Morgan today the CEO of Eyepoint seemed to spend most of his presentation acting like Ocular Therapeutix is not a significant competitor in the Wet AMD market. When asked specifically about the upcoming release of SOL-1 data he stated: "So at a high level I think we already know this TKIs work. There's been to my knowledge now [--] TKI trials with various delivery systems intravitreal orally suprachoroidal in wet AMD and they've all been positive. And so I do expect this study to show a positive benefit of TKIs." https://twitter.com/i/web/status/2011156374944956577"
X Link 2026-01-13T19:20Z [---] followers, [----] engagements
"$AQST Buyout Talk - Sorry Waiting Required When Anaphylm approval happens I expect to hear significant buyout speculation. I have previously asserted that a buyout is unlikely until more is known about the efficacy of AQST-108 topical gel. Variations of that product might produce more revenue than Anaphylm. Dan made a statement on the call this week that many likely missed. He declared that they would be continuing work on AQST-108 this year because they need to make sure and understand the long-term value of this product. Understanding the efficacy of AQST-108 is going to take significant"
X Link 2026-02-06T16:15Z [---] followers, [----] engagements
"$OCUL Saw where they listed new job openings today on Linkedin. Hmmm (9 jobs added in last [--] hours. Pure speculation about what this means. Yet gets my attention)"
X Link 2026-02-13T22:31Z [---] followers, [----] engagements
"$OCUL What to Look for with SOL-1 Results: On Tuesday we will get the topline results from the SOL-1 (Phase [--] wet AMD) study for AXPAXLI. It is comparing a single AXPAXLI injection to a single Aflibercept (2 mg) injection. The key question to be answered is: How long does each drug last With topline results we will need to see how detailed they get with the results. I expect a measure of the statistical significance of the differences between the two groups. I am anticipating this to be a strong number. This may be based on comparing the number of rescues in each group. The main focus will be"
X Link 2026-02-14T18:10Z [---] followers, [----] engagements
"$NVCT NXP900 Phase 1b Trial This study of NXP900 has [--] arms including both monotherapy and combination groups. The combo groups have less restrictive enrollment requirements. It is difficult at this point to determine the enrollment rate for each arm. However they anticipate that there will be multiple readouts in [----]. The earliest could happen in 2Q [----]. https://twitter.com/i/web/status/1995857120860705133 https://twitter.com/i/web/status/1995857120860705133"
X Link 2025-12-02T14:06Z [---] followers, [---] engagements
"$NVCT Initiation of the Phase 1b Study of NXP900 -They are done with the dose escalation of NXP900 alone. A dose has been selected. -Now they begin a combo study NXP900 with osimertinib (EGFR Inhibitor). -Participants with epidermal growth factor receptor mutated (EGFR mut+) non-small cell lung cancer (NSCLC) -Only [--] treatment locations. Yet these are top level sites in the US and UK who have high volume: Mayo Clinic MD Anderson . . . -They indicate to expect updates in [----]. I presume the first update may be focused on safety data. Maybe in late [----] we get some early efficacy results"
X Link 2025-12-17T16:41Z [---] followers, [---] engagements
"$ABEO sold rights to TSHA-102 a gene therapy for Rett's Syndrome in exchange for royalties and milestone payments. First Patient Announced Today: https://ir.tayshagtx.com/news-releases/news-release-details/taysha-gene-therapies-announces-progress-across-tsha-102-pivotal https://ir.tayshagtx.com/news-releases/news-release-details/taysha-gene-therapies-announces-progress-across-tsha-102-pivotal"
X Link 2026-01-06T19:32Z [---] followers, [----] engagements
"$MDXH Genomic Prostate Score (GPS) test to be used in key study. https://mdxhealth.com/press_release/mdxhealth-and-university-of-oxford-to-validate-gps-test-in-largest-randomized-trial-of-treatment-effectiveness-in-patients-with-localized-prostate-cancer/ https://mdxhealth.com/press_release/mdxhealth-and-university-of-oxford-to-validate-gps-test-in-largest-randomized-trial-of-treatment-effectiveness-in-patients-with-localized-prostate-cancer/"
X Link 2026-01-07T14:40Z [---] followers, [---] engagements
"It seems I learn about a new cell therapy company every day. It is clear that many of these companies are not going to make it with such intense competition. My favorite right now is $FATE but I am always looking to challenge my assumptions. What is distinctive about $NKTX They appear to require lymphodepleting chemo. I am not able to find any outcome data to date. https://twitter.com/i/web/status/2014742092774260805 https://twitter.com/i/web/status/2014742092774260805"
X Link 2026-01-23T16:48Z [---] followers, [---] engagements
"$CRDF The limited data presented today just prompts more questions than answers. This data is not mature enough to reach conclusions about the PFS results. I really liked the depth of response shown in the spider plots during the last data release. The lack of charts and graphs in today's presentation was disappointing. In summary I need to see more. Some of what I need to see requires at least another [--] months of data collection. When you are adding to an established standard of care that often prompts an initial response you should not rush the outcome data. This is an easy drug to add to"
X Link 2026-01-27T14:32Z [---] followers, [----] engagements
"If you look at their phase [--] lung data that was released in January is does show some encouraging Overall Survival Data: median OS [----] vs [----] months. Yet there is none of the traditional information about tumor status. Instead they focus on absolute lymphocyte count (ALC). So these are not bad results. They just omit traditional data. Also the results suggest a step forward rather than a cure for cancer. These positive results need to be tested versus a control group in the ongoing phase [--]. https://twitter.com/i/web/status/2017303868347134192"
X Link 2026-01-30T18:28Z [---] followers, [--] engagements
"$AQST Monday Monday . . . It is that time of the day when any news becomes much less likely. Oh how many times I refreshed the Aquestive Press Release page today after market closing. Likely I will be doing that again on Monday morning. I do not read anything into this. Too little information to reach big conclusions. Time to Wait"
X Link 2026-01-30T21:51Z [---] followers, [----] engagements
"I am not reading the $SPRY financials that way. Let's see what they report at the next quarterly but they are burning cash at a very high rate. They are a long way from being profitable. It appears they will not be profitable without a big increase in market share. So who knows what the future brings. Yet take a look a the most recent financials and explain what indicates they are "past that bleed." https://twitter.com/i/web/status/2017997581029130619 https://twitter.com/i/web/status/2017997581029130619"
X Link 2026-02-01T16:24Z [---] followers, [---] engagements
"We lack enough information to make a well-informed guess. So let that set in before reading my next statement. I will say that the most likely result is $AQST reporting Monday during pre or post-market hours that they are still working with the FDA and the application remains under active review. So no real change from the current status"
X Link 2026-02-01T17:14Z [---] followers, [----] engagements
"@JessieChimni @thecellengineer @Octopusking77 I confirm that about $FATE. Yet I think $ACET just started their phase [--] a couple of weeks ago. Correct me if I am missing something"
X Link 2026-02-02T15:27Z [---] followers, [---] engagements
"@richtrades100 @Jonny_fun_guy For $SPRY the FDA decision only took [--] months after resubmit. Therefore we could see an $AQST approval in October. CRL is an easy fix"
X Link 2026-02-02T15:52Z [---] followers, [---] engagements
"$OCUL Results Timing Yes I expected SOL-1 data sooner. That was just a guess. The timing released today is still reasonable. I do not see it as sending a message. So the only question now is do they release data the week of Feb [--] or do they wait until the week of Feb [--] to create more of a buzz at the Macula Society meeting. Key statement: "SOL-1 (Phase [--] wet AMD) superiority trial on track for topline data in the second half of February [----]. Week [--] results for the SOL-1 trial are expected to be presented at the 49th Macula Society Annual Meeting taking place between February [--] [--] 2026.""
X Link 2026-02-05T13:54Z [---] followers, [----] engagements
"If you have not waited on edge for a conference data release checking to see the presentation time and the embargo rules you are not an experience biotech investor. Please provide one example of the SEC going after a company in this context. They might if the delay was something like six months to a year. This is a case of at most a few weeks"
X Link 2026-02-05T15:34Z [---] followers, [---] engagements
"$DAWN Quarterly (& Annual) Feb [--] https://ir.dayonebio.com/news-releases/news-release-details/day-one-report-fourth-quarter-and-full-year-2025-financial https://ir.dayonebio.com/news-releases/news-release-details/day-one-report-fourth-quarter-and-full-year-2025-financial"
X Link 2026-02-10T14:14Z [---] followers, [---] engagements
"$PDSB $MRUS $BCAX Head & Neck Cancer Treatment This is an document where the focus is the patient perspective yet many investors will find this content helpful. https://twitter.com/i/web/status/1961078189192585705 https://www.reddit.com/r/NewCancerTreatment/comments/1mcc1q8/a_basic_guide_to_new_treatments_for_head_and_neck/ https://twitter.com/i/web/status/1961078189192585705 https://www.reddit.com/r/NewCancerTreatment/comments/1mcc1q8/a_basic_guide_to_new_treatments_for_head_and_neck/"
X Link 2025-08-28T14:47Z [---] followers, [----] engagements
"$NVCT Quarterly Update "Laying the groundwork for multiple potential data readouts in [----]. " "Our Phase 1b monotherapy study evaluating NXP900's clinical potential in several molecularly and histologically-defined target tumors and the combination study of NXP900 with osimertinib in patients with EGFR-mutated non-small cell lung cancer ("NSCLC") are enrolling patients. In addition a combination with lorlatinib in ALK-positive NSCLC is pending commencement." Corp Presentation states: "Multiple clinical data updates from the Phase 1b program from mid to YE 2026.""
X Link 2026-02-11T14:43Z [---] followers, [---] engagements
"@jfais20 Strange comparison to make. $IOVA treatment centers need a surgery team ready to act fast. You are comparing that to cell therapy treatment centers"
X Link 2026-02-13T18:08Z [---] followers, [---] engagements
"$AQST Summary of Current Status The FDA says that the drug works. The FDA Clinical Pharmacology team has given it the green light. The drug manufacturing is good. The FDA Chemistry Manufacturing and Controls team has given approval. The FDA Human Factors team wants to make sure the drug gets used correctly. They want to know more about the consequences of user errors like chewing the film or placing it on the top of the tongue. They want the package to be easy to open. Aquestive will run two quick studies. Yet the most important response will likely be to modify the packaging to make it a"
X Link 2026-02-03T15:22Z [---] followers, [----] engagements
"$ABEO $RARE UX111 CMC Incomplete Response Letter Update (Feb [--] announced resubmit Feb [--] letter requesting more documentation.) "We had provided complete responses to each CRL item but now the FDA is requiring additional details within support of documentation on the CMC. CRL responses made and their impact. This information is typically provided during an inspection and we were prepared to do so but will now provide the support of documentation as a part of our BLA resubmission." "The list of issues on the CRL are known to both part to FDA and US. Obviously we have the same list but the"
X Link 2026-02-13T16:22Z [---] followers, [---] engagements
"$OCUL Control Group Expectations I have been giving more thought about what to expect from the control group. Typically a single Aflibercept (2 mg) injection would be given every [--] months. Some activity of the medication probably extends for another month. When the potency of the medication gets lower that should trigger vision loss. Yet it could take an extended time for the vision loss to reach the rescue criteria in this study. My initial expectation was that there will be a large proportion of the control group that will need rescue at [--] months. Yet that may not be the case. It could take"
X Link 2026-02-15T17:20Z [---] followers, [----] engagements
"They reported that one person was alive at [--] months. I am sure you are new to cancer treatment and do not mean to present false information. Please learn more about how to interpret cancer outcome data before posting content like this. This has not stunned the medical community. They would never jump to such a conclusion without better data. It will take more time before the data is available to judge these results. This CEO is a hype man. Follow the data wherever it leads not the hype. https://twitter.com/i/web/status/2015919451955175786 https://twitter.com/i/web/status/2015919451955175786"
X Link 2026-01-26T22:47Z [---] followers, [---] engagements
"I aspire to identify stocks that can be purchased now and held for a year to achieve long term capital gains. I seek to identify stocks that will at least double in value. I encourage you to consider these stocks yet do your own research before investing"
X Link 2025-01-25T16:32Z [---] followers, [----] engagements
"I now consider my purchase of $PDSB stock and holding it for [--] years to be a donation to life saving cancer research. There is a chance I realize a huge profit but regardless I have supported what is right and good. On days like today it is nice to feel good about something"
X Link 2025-02-24T15:25Z [---] followers, [----] engagements
"Forward Thinking U.S. Patent $AQST had an interesting Patent accepted on 12/24/2024. It envisions devices worn by persons sending data to physicians with recommendations for personalized prescriptions which would be compounded using an automated system at an FDA authorized facility and sent to clients directly by the manufacturer. It includes individualized medications that use film technology. One example is those who have allergies to inactive ingredients in medications who need special formulations. This patent builds on several other patents they have filed detailing components of this"
X Link 2025-03-26T14:59Z [---] followers, [---] engagements
"$AQST I saw a post elsewhere about the death of Dr. Stephen Paul Wargacki Chief Science Officer on March [--] [----]. He was promoted to that position last summer after many years with the company. Very Sad I know his family friends and coworkers are grieving his loss. He played a significant role in bringing Anaphylm to where it is today. I give thanks for all the good he brought to the world. I express sympathy to all those experiencing loss"
X Link 2025-04-09T13:35Z [---] followers, [----] engagements
"$AQST Lessons from Neffy (version 2.0) (I recently obtained new information that required the revision of prior content.) One of the issues faced by Neffy when they sought FDA approval was demonstrating that careful consideration had been given to new problems that could emerge with the shift to a different mode of administration. A study was conducted to demonstrate that there were no significant differences in PK (blood concentration) and PD (heart rate and pulse) when participants had upper respiratory infections. At some point it was recognized that nasal congestion could impact"
X Link 2025-04-10T21:43Z [---] followers, [----] engagements
"$SPRY $AQST ARS CEO Statement About Bracketing And Other Data During the 3/20/25 quarterly call the ARS CEO stated Neffy remains the only approved product to have generated anaphylaxis efficacy data in a clinical study to have met the bracketing criteria established by FDA for approval of all key pharmokinetic parameters to ensure safety and efficacy and to have data demonstrating that it is well tolerated in children down to 15kg body weight who account for almost half of the patients prescribed epinephrine. I begin by acknowledging that this statement is true. Yet it is a long conditional"
X Link 2025-04-27T15:09Z [---] followers, [----] engagements
"$PDSB More treatment centers have been added for Phase [--] study. Hopefully we will see several more soon"
X Link 2025-04-30T23:02Z [---] followers, [----] engagements
"$CAPR There is a common fundamental misunderstanding of FDA ADCOMs. They do not delay the process. They provide more opportunity for the company and advocacy groups to make their case. In the ones that I have observed members of the committee ask good questions and make wise statements. They express practical and complex views of issues. They push the FDA staff to make good decisions. Given the great safety data and the encouraging outcome data for this treatment this Adcom has great potential to provide additional support for approval"
X Link 2025-05-05T18:59Z [---] followers, [----] engagements
"$CAPR $SRPT I have been critical of some of the decisions of Peter Marks. Yet these statements by Vinay Prasad are dangerous. This is not someone that should be in a position of leadership at the FDA"
X Link 2025-05-06T17:59Z [---] followers, 16.4K engagements
"$CAPR FDA Process Update "Path has been smooth." "FDA has not fallen behind in any way." "No substantial issues." FDA site inspection "within next few weeks." Label discussion meeting is scheduled for later this Summer. No date set yet for meeting before Cellular Tissue and Gene Therapies Advisory Committee. $CAPR has conducted two mock ADCOMs. Result was "passed with flying colors." Clarified that measure: Left Ventricular Ejection Fraction (LVEF) is being treated as an "outcome measure" by FDA not as a "surrogate measure.""
X Link 2025-05-13T21:29Z [---] followers, [----] engagements
"$AQST Back to Basics The basic case for $AQST is that Anaphylm has the data it needs to be approved by the FDA. A key component is the results from the oral allergen study that matches the design recommended to them by the FDA. (AQST had proposed a different study design but they adopted the FDA's design.) In the Neffy ADCOM many reviewers stated that evaluating Neffy was very difficult because they did not have this kind of data. It also has a product that offers portability that cannot be matched by any device-based competitor. If Anaphylm is approved and dominates the epinephrine rescue"
X Link 2025-05-20T16:56Z [---] followers, [----] engagements
"$MRUS $PDSB Merus 5/22 Call There is excitement about the Petosemtamab phase [--] results that will be presented at ASCO. Merus released the highlights of these results on May [--]. In the conference call Merus claimed that Petosemtamab is "substantially derisked." They said it has a "high probablity of meeting the needs of the entire metastatic PDL-1 positive first line market." It appears they did not even collect data on the HPV16 status of their [--] HPV+ participants of the [--] total participants. I could not find any indication that they will do this in the phase [--]. I would not expect"
X Link 2025-05-26T13:50Z [---] followers, [----] engagements
"$IOVA From tonight's presentation: Amtagvi patients are heavily pretreated patients. Most have at least [--] prior treatments. (We know from other cancer research that those who have had a significant number of prior treatments are less likely to respond to a new treatment.) There is still work to do to gain insights into which prior treatments impact the efficacy of Amtagvi"
X Link 2025-06-01T00:33Z [---] followers, [----] engagements
"$AQST I am anticipating FDA acceptance of the Anaphylm NDA on approximately Tuesday June [--]. If I am correct that is about a week away. (For fun comment with the day you guess - sorry no prize - just a little playful fun) All that follow AQST closely likely expect the NDA to be accepted. I do not see them having problems with poor study design lack of safety data or lack of manufacturing documentation. Yet I still think seeing a specific PDUFA date will put this on the radar for some. I am one who periodically checks the PDUFA list and sometimes I follow with an investment. A recent example"
X Link 2025-06-02T01:37Z [---] followers, [----] engagements
"$ABEO Lab Capacity All is progressing well with ZEVASKYN rollout. -There are about [---] patients in the US that they are targeting. It will be common for them to receive at least two treatments. Each treatment is [---] million. If they provide [--] treatments a month they will be profitable. (That is positive cash flow for [--] patients a year.) - The goal is [--] to [--] treatments in [----]. They are thinking [--] treatments in [----]. It seems they are being cautious with these numbers. -First treatment center online. Four more added very soon. -They will start with lab capacity of [--] treatments per month."
X Link 2025-06-04T16:43Z [---] followers, [---] engagements
"$MREO $RARE Orbit study: Database locked at end of April (all at minimum of [--] months some up to [--] months) "Database cleaning could take up to [--] months." Cleaning started at end of April. "If we have not made an announcement the DMC has not met." Cosmic Study: "Data has been cleaned in parallel." Results with Cosmic will be available later than Orbit. Denise Scots-Knight CEO $MREO"
X Link 2025-06-04T21:47Z [---] followers, 13.3K engagements
"$AQST Stock Price Up 40% in a Week Over a period of a week we have seen the stock price of $AQST go up $1.07 about a 40% rise. Clearly there is expectation of FDA action by next week to approve the application for Anaphylm. My assessment is that this stock should be at about $5 right now. At least $4 seems achievable with an FDA announcement. It may even reach that before the FDA announcement if word does not arrive until Wednesday or later. I do not claim to be gifted at short-term stock price prediction. Yet the momentum from the last week suggests this stock price has awakened as Anaphylm"
X Link 2025-06-06T16:05Z [---] followers, [----] engagements
"$PDSB Circulating Tumor DNA (Part [--] -NAV DX) Some may observe that circulating tumor HPV DNA is a great measure for the research setting but it will probably not be practical for this test to be used in everyday clinical practice. The big surprise is that last year a company started making this test available in the US. Recently I have noticed persons on social media posting their test results to celebrate that no cancer was found in the bloodstream after finishing treatment. (See: The test is increasingly covered by insurance. For those without insurance the cash price is about $2200. It"
X Link 2025-06-14T13:39Z [---] followers, [---] engagements
"$SRPT Ambulatory vs. Non-ambulatory On the call today it was reported that they have not seen this serious liver issue in ambulatory participants. The non-ambulatory group is one where there has been much more severe disease progression. The future of serving the non-ambulatory group is uncertain at this point. The use of Sirolimus for immunosuppression is being explored. This year those receiving Elevidys have been 70% Ambulatory and 30% Non-ambulatory. Since beginning the treatment the numbers are 85% Ambulatory and 15% Ambulatory. If they move to only Ambulatory there is still a"
X Link 2025-06-16T12:54Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Kevin Harrington MBBS Ph.D.The Institute of Cancer Research United Kingdom Key Point from Dr. Harrington Presentation:"
X Link 2025-06-17T17:02Z [---] followers, [----] engagements
"$PDSB FDA - Diagnostic Test Program The FDA request for $PDSB to work with them on a diagnostic test for HPV16 in tumors appears to be related to the program in the attached document. Here are a couple of key elements: "FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers should meet. Through this transparency FDA seeks to support better and more consistent performance of certain LDTs used to identify patients for treatment with certain oncology drug products resulting in better drug selection and"
X Link 2025-06-18T15:15Z [---] followers, [----] engagements
"$CAPR The removal of Nicole Verdun MD at the FDA is a surprise. She certainly appeared to be a very accomplished scientist. I am not sure what the impact will be on FDA regulation of cell and gene therapies. Anybody who does is probably not talking publicly right now. Uncertainty has sparked after hours selling of $CAPR. At this stage of the process it is unlikely that there will be any changes in the key FDA staff relating directly to Deramiocel approval. Who is in this leadership role and why they are there will have an impact on future interactions with the FDA but likely minimal"
X Link 2025-06-19T00:01Z [---] followers, [----] engagements
"$CAPR I have not read the full statnews article by Adam Feuerstein. There is no way I would give them $30 for the right to do so. I have found Adam Feuerstein to be an unreliable source in the past. Who on the inside with credible information would tell their story to StatNews and not the Washington Post or New York Times The part of the article I can read says that the ADCOM was cancelled because Prasad was skeptical of Deramiocel. If one is skeptical why cancel an ADCOM That does not make sense. I will reserve judgment until I hear about this from a source I consider reliable. When a story"
X Link 2025-06-20T18:07Z [---] followers, [----] engagements
"$CAPR HOPE-2 Year [--] (Part 1) It took me some time but here is what I think the HOPE-2 press release results are saying: To measure motor function the study used a assessment designed for DMD patients called PUL v2.0 (Performance of the Upper Limb). It includes tasks like raising arms above the head stacking cans removing a lid from a container and tracing a path. "Treatment continued to slow skeletal muscle disease progression as measured by Performance of the Upper Limb (PUL v2.0) with patients experiencing a smaller average decline in the fourth year (0.6 points) compared to the first year"
X Link 2025-06-21T13:51Z [---] followers, [----] engagements
"$CAPR Looking at LVEF in DMD Left ventricular ejection fraction (LVEF) evaluates how well the heart's main pumping chamber the left ventricle is functioning. LVEF values are reported as the percentage of blood pumped out of the left ventricle with each heartbeat. The normal range for LVEF is about 50-70%. When you have values below 50% it is common to use terms like heart failure and cardiomyopathy. The first graph below shows there is a strong relationship between a low LVEF percentage and death for those with DMD. It displays that those with a 35% LVEF have about a 50% chance of dying"
X Link 2025-06-25T13:37Z [---] followers, [---] engagements
"$PDSB HPV Circulating Tumor DNA I recently encountered a study published in [----] that looked at Circulating Tumor DNA (ctDNA) prior to treatment for those with HPV positive cancer. A test of ctDNA looks at evidence of cancer activity in the bloodstream. The study used data collected at Dana-Farber Cancer Institute in Boston. Types of HPV The vast majority of those in this study had HPV DNA that was identified as HPV16 (n = [--] 88%). The others were: HPV-33 (n = [--] 8%) HPV-35 (n = [--] 2%) HPV-31 (n = [--] 1%) and HPV-18 (n = [--] 1%). This study confirms that a substantial majority of those with HPV"
X Link 2025-06-30T18:57Z [---] followers, [---] engagements
"$CAPR HOPE-3 Misinformation There is a biotechtv video going around with a Jones Research Analyst where they take STAT News as a reliable source. Mistake #1 Then they say - we now know that the FDA is going to make $CAPR use HOPE-3 data for initial approval but this data lacks heart measures so it can only be approved on motor changes. Mistakes #2 & [--]. There are LVEF heart measures in HOPE-3. Yes they could have to use this data. However $CAPR has not been told that to date. Therefore they are speculating but conveying that view as fact. We are on our own here. We have to take the time to"
X Link 2025-07-01T20:18Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Who is the Early Winner (Part 2) For Head and Neck cancer there are three distinct groups: 1) HPV negative 2) HPV16 3) HPV positive who are not HPV16 Within each of these groups there are three important subgroups: 1) CPS = [--] 2) CPS 1-19 3) CPS [--] We know from past studies that Keytruda tends to work better for those with high CPS scores. In the Keynote-048 Study Keytruda Alone CPS [--] Median Overall Survival: [----] months CPS 1-19 Median Overall Survival: [----] months CPS scores tend to be higher in the HPV positive group. About 5% of those with HPV positive cancer have CPS ="
X Link 2025-07-03T14:14Z [---] followers, [----] engagements
"$PDSB Reflections on Today's News So we get news today that PDS01ADC appears to enhance the efficacy of a chemotherapy drug for those with tumors in the liver with a kind of cancer that is really hard to treat. It seems to do so without adding significant side effects. This is a result that will get the attention of big drug companies. They start thinking about the numbers if this was added to a substantial number of chemo treatments. They begin imagining Keytruda revenue numbers. Yet as I write this the stock is down 2%. Yes these results are not conclusive yet. We need to see some solid"
X Link 2025-07-10T14:08Z [---] followers, [----] engagements
"$SRPT Report of LGMD Study Participant Death I have not seen a statement from the company yet about this death. They had indicated this liver issue was not thought to be a significant risk for LGMD treatment due to lower doses. This is tragic and makes it less likely that another company will quickly resume this research. Then there is the question about when $SRPT knew about this death. I will wait for the $SRPT statement but if they knew about this yesterday there should have been at least a statement that they are investigating a very serious health event related to a LGMD patient. I also"
X Link 2025-07-18T01:45Z [---] followers, [----] engagements
"$SRPT Reflections on the Call Today I rarely praise analysts. Today many of them asked direct and strongly worded questions that held Doug accountable. Many of Doug's answers were not acceptable. The problematic responses centered around materiality and disclosure. I particularly appreciate analysts asking "How will events be disclosed in the future" Doug indicated that his duty to disclose is very different for clinical trials versus approved products. He indicated that it is fine to wait to report death events like this in scientific papers presented at research conferences. It appears he"
X Link 2025-07-18T15:51Z [---] followers, [----] engagements
"$PDSB Versamune Prior to Cancer Diagnosis in High-Risk populations - New Clinical Trial There have been statements by some leaders in cancer treatment about the possibility of using Versamune HPV in persons who are at high risk for HPV16 cancer. The first step toward that becoming a reality is a new clinical trial for those with HIV and HPV16. Versamune HPV (PDS0101) generates killer and helper T-cells that go after HPV16 cancer. It is designed to generate T-cells to target E6 and E7 oncoproteins which play a key role in the cancer-causing activity of HPV16. It uses a cancer vaccine approach"
X Link 2025-08-03T18:02Z [---] followers, [----] engagements
"$CAPR The return of Prasad does bring some unpredictability. Yet his successor might have been worse. Yes it is crazy weird to bring him back two weeks later. What changed These guys talk constantly about increasing transparency at the FDA while we are shielded from much of what is driving erratic personnel and drug decisions. Will Prasad [---] be more measured and cautious I do not have the answer. The next big thing is the type A meeting where $CAPR will make reasonable requests that the FDA should grant. I do not see any reason for that to not go well. We should have word on that very soon."
X Link 2025-08-11T14:32Z [---] followers, [----] engagements
"$AQST Next Step - ADCOM Decision It is approaching time for the FDA to conduct a mid-cycle review. This is an internal FDA meeting. It is common at this meeting for a decision to be made about if an ADCOM will occur later in the process. This means that within the next month the company is likely to learn if the FDA plans an ADCOM. The actual ADCOM would not happen until later in the year - likely November. Personally I hope there is an ADCOM. Dan has been clear that he prefers an ADCOM"
X Link 2025-08-12T13:15Z [---] followers, [---] engagements
"$AQST Pediatric Study PD Results The PD results were released today for the pediatric study. This data looks good. The blood pressure data is the most important. I like the shape of the curve. The degree that this matches the general rise and fall of the adult curve is encouraging. When two datasets look this similar it is because the dosage and absorption rate is quite consistent across medication administrations. Typically we do not see this kind of consistency with IM injections"
X Link 2025-08-12T13:49Z [---] followers, [----] engagements
"$CAPR Type A Meeting I am expecting a press release on Monday about the results of the Type A meeting. If we do not hear from $CAPR soon I will conclude that the FDA did not provide clear guidance at this meeting and indicated that they would get back to them when they reach a decision. If FDA leadership is micromanaging review staff decisions there could be some delays. I remain confident in the strength of the data and await clarity about the next steps"
X Link 2025-08-14T18:41Z [---] followers, [---] engagements
"$SPRY $AQST Looking Ahead The next few months are going to be interesting to watch $SPRY. The upcoming quarter should bring a robust increase in sales with the back-to-school push. In the chart below the last three values on the X axis are in the 3rd quarter. The growth is encouraging but these are still fairly modest numbers with each mark on the Y axis representing [----] units. This company is still a long way from being profitable. They also plan for significant advertising spending through early [----]. Their adverting is really good but it is expensive. If $SPRY had a clear path to keep"
X Link 2025-08-15T14:47Z [---] followers, [----] engagements
"$AQST Fall in stock price may also be linked to $SPRY being granted FDA approval for young children. Again not a rational reason. That FDA approval is actually a positive sign of what $AQST can anticipate at the FDA"
X Link 2025-03-05T21:59Z [---] followers, [---] engagements
"ARS Pharmaceuticals Announces FDA Approval of neffy [--] mg (epinephrine nasal spray) for Type I Allergic Reactions Including Anaphylaxis in Pediatric Patients Weighing [--] to [--] Kilograms - ARS Pharmaceuticals"
X Link 2025-03-05T22:02Z [---] followers, [---] engagements
"$AQST $SPRY Other Nasal Sprays - Part [--] Another company that has worked on a epinephrine nasal spray is Nasus Pharma. They use a powder that is sprayed in the nose. An advantage is that a powder is more stable than a liquid. I am concerned that many consumers will not like the concept of putting a powder in the nose. (Yes the obvious humor can be found here with use of a white powder in the nose.) In their PK studies my evaluation is that a single dose in one nostril does not result in ample epinephrine in the bloodstream. Their PK numbers when a dose is administered to each nostril looks"
X Link 2025-05-28T14:58Z [---] followers, [---] engagements
"@northernboston You speak of a paradigm shift with Neffy being the new global standard. Why are you pushing $SPRY hard without acknowledging the next paradigm shift that is likely to come early next year with $AQST getting approval for Anaphylm Needle-free is a great step forward. Yet the next wave is the device-free era. Neffy will have a product that costs much more to produce and that can not compete on portability. If people buy $SPRY with their eyes open to this reality that is great. Maybe they are convinced that Anaphylm will never be approved. I think that is silly but everyone needs"
X Link 2025-08-27T16:49Z [---] followers, [---] engagements
"$MCRB My take: They think they can get more than what Nestle offered. We will see if they are right. My guess is they have made a counter offer to Nestle that is closer to [--] billion. Nestle initially responded by telling the press about the offer. They want stock holders to put pressure on Series so they do not have to raise their offer much. One problem with this approach from Nestle is that it tells other companies that the Nestle offer is serious and anything they offer needs to be higher. For the stock to crash like this you need to believe that the Series execs will mess up this"
X Link 2025-09-09T17:14Z [---] followers, [---] engagements
"$GMAB $MRUS $BCAX $PDSB WHAT The $GMAB acquisition of $MRUS for $8B is really puzzling. $MRUS has a head and neck cancer drug with a mechanism that is focused on the HPV negative market. This market is shrinking due to lower smoking rates in the US and Europe. $BCAX has a drug for the HPV negative market that appears to have much better depth of response than the $MRUS drug. The flashy $MRUS ORR numbers are not likely to translate into an OS (Overall Survival) advantage over $BCAX. $BCAX seems to especially have an advantage for those with low CPS scores which is typical for the HPV negative"
X Link 2025-09-30T16:35Z [---] followers, [---] engagements
"$PDSB $BCAX $JNJ At ESMO encouraging results were presented for use of Amivantamab for those with HPV negative cancer. In combines a EGFR and MET inhibitor with an immunotherapy. An announcement about phase [--] trials should come soon. "We reported data on two populations: the safety population of [--] patients who received at least [--] dose of the drug and the efficacy population of [--] patients who had at least [--] tumor assessments or had stopped treatment for any reason. The efficacy data relate only to that smaller subset of patients." Of the five cohorts in this study there appears to have been"
X Link 2025-10-21T15:57Z [---] followers, [----] engagements
"$NVCT So the key poster released today has safety data for NXP900. My thoughts are that it appears the medication is tolerated quite well. The key goal was improve safety so that it looked like this while maintaining efficacy. So now we need confirmation of efficacy. The drug is likely to work best at part of a combo. Therefore it will also be important to eventually see safety and efficacy data when it is taken with a med like an EGFR inhibitor. https://nuvectis.com/wp-content/uploads/First-in-human-phase-1-trial-of-NXP900-in-patients-with-advanced-solid-tumors-AACR-2025.pdf"
X Link 2025-10-23T18:37Z [---] followers, [---] engagements
"$NVCT Higher Res NXP900 posters and additional comments now available. https://nuvectis.com/press-release-view/i=158794 https://nuvectis.com/press-release-view/i=158794"
X Link 2025-10-27T13:08Z [---] followers, [---] engagements
"$KYTX Phase [--] MG Results (n=6) https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-positive-interim-phase-2-data https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-announces-positive-interim-phase-2-data"
X Link 2025-10-29T12:09Z [---] followers, [---] engagements
"$NVCT Upcoming Event Dec [--] I am looking forward to this event. I expect to learn information that will aid interpretation of future results. https://nuvectis.com/press-release-view/i=159884 https://nuvectis.com/press-release-view/i=159884"
X Link 2025-11-25T17:27Z [---] followers, [---] engagements
"$SPRY $AQST Pricing ARS reports that Neffy pricing in Germany and UK is two times the EpiPen price"
X Link 2025-12-03T19:57Z [---] followers, [----] engagements
"$AQST $SPRY New York law expands definition of epi rescue meds to include Neffy and Anaphylm. https://www.healio.com/news/allergy-asthma/20251209/new-york-governor-signs-two-allergy-bills-into-law https://www.healio.com/news/allergy-asthma/20251209/new-york-governor-signs-two-allergy-bills-into-law"
X Link 2025-12-10T17:33Z [---] followers, [---] engagements
"$AKBA Akebia Therapeutics Announces First Patient Dosed in Phase [--] Clinical Trial of Praliciguat for the Treatment of Focal Segmental Glomerulosclerosis (FSGS) https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-first-patient-dosed-phase-2 https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-first-patient-dosed-phase-2"
X Link 2026-01-06T14:30Z [---] followers, [---] engagements
"$PDSB The key words from today's news: "Based on the dialogue we had with the agency in December we are confident that we have a pathway to potentially accelerate our regulatory submission"
X Link 2026-01-09T15:25Z [---] followers, [----] engagements
"$KYTX $RNAC MG Data Statement When the green graphs below were shown today at the $KYTX presentation it was reported that no others have achieved this in MG. The second slide with red lines comes from a $RNAC study. The results look similar to me. There are plenty of problems with making these kinds of comparisons. Yet $RNAC is in phase [--] with this treatment. Their treatment is delivered in an outpatient setting without Lymphodepleting Chemotherapy. Yes it takes [--] doses but you do not need a hospital stay. This may lead to the first FDA approved autoimmune treatment without Lymphodepleting"
X Link 2026-01-14T20:40Z [---] followers, [----] engagements
"$OCUL DATA TIME I know all the chatter is about a buyout. Where my attention is focused is on the data. It is data time There is a good chance we get results this week. (I am expecting results before February. We will see . . .)"
X Link 2026-01-19T17:05Z [---] followers, [----] engagements
"$IBRX To make a smart investment in a stock like this. You need to: 1) Understand cancer research 2) Have knowledge of existing treatments 3) Understand FDA practices 4) Know what competitors are doing For example the FDA typically requires cancer drugs to have registrational studies where some of the participants are randomly assigned to a control group. Yes there are a few exceptions to this practice. Sometimes exceptions are granted for rare diseases. Occasionally single-arm studies are accepted when persons have exhausted all other treatment options and quick death is almost guaranteed."
X Link 2026-01-30T16:24Z [---] followers, [----] engagements
"Look at the phase [--] lung cancer data they released this month. It shows some encouraging Overall Survival Data: median OS [----] vs [----] months. Yet there is none of the traditional information about tumor status. Instead they focus on absolute lymphocyte count (ALC). So these are not bad results. They just omit traditional data. Also the results suggest a step forward rather than a cure for cancer. These positive results need to be tested versus a control group in the ongoing phase [--]. Again I am encouraged by results like this. They just need to be interpreted with care."
X Link 2026-01-30T18:43Z [---] followers, [--] engagements
"Yes for swallowing. They have hard data there that was posted about a year ago. I have not seen hard data for top of tongue but the tongue is highly vascular compared to many other tissues in the body. If these human factors folks at the FDA took a look at the science they would not make this request"
X Link 2026-02-02T15:58Z [---] followers, [---] engagements
"$AQST Anaphylm FDA submission complete by 3/31. FDA has [--] days to consider acceptance of application followed by [--] days to send decision letter (74 days total). So answer before Friday June 13th. Letter contains PDUFA date"
X Link 2025-03-10T21:02Z [---] followers, [---] engagements
"$AQST Bracketing & The FDA Anaphylm is being considered for FDA approval under the 505(b)(2) program which permits using preexisting data to approve the drug. Basically there is not a need to prove that Epinephrine is effective in treating allergic reactions. Anaphylm needs to show evidence that it delivers appropriate amounts of Epinephrine. A word that has frequently been used when evaluating the equivalence of new epinephrine rescue medications to existing ones is bracketing. When Neffy recently went through this process the FDA bracketing standard was never rigidly applied. It started"
X Link 2025-04-15T12:43Z [---] followers, [----] engagements
"$ABEO Some Highlights of Today's Call -Three patients per month is break even. -Will begin serving patients soon - 3rd Quarter. Goal of [--] to [--] patients served by end of [----]. -One month lab shut down in December. -Announcement coming soon about plans to expand capacity of US lab. -They will begin working on access to markets outside US now. -The shelf life of the product is [--] hours. So it is challenging to manufacture in US and supply to markets far from US. Eventually will need to have lab outside US. -Last few priority vouchers have sold for about [---] million. They hope to negotiate a"
X Link 2025-04-29T15:25Z [---] followers, [----] engagements
"$PDSB Very helpful information this morning that P16+ and HPV16 are different designations. HPV16+ is a subgroup of those said to be p16+. Those in the HPV16+ are the focus of PDSB research. It is group that is less response to Keytruda alone"
X Link 2025-05-23T14:43Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Proportion HPV + or HPV - (Part 2) I have been trying to get a grasp on the numbers of HPV positive versus HPV negative Head and Neck Cancer patients. This is really difficult because the numbers are changing and vary dramatically based on country. Here are my efforts to sort out the proportions in the US. First my best estimate is that 70% of those in the US with Head and Neck Cancer are HPV +. This is what Grok said: "The proportion of HPV-positive head and neck cancers particularly OPSCC has been increasing over time. In the U.S. studies show a rise from 20.9% before 1990"
X Link 2025-06-15T14:58Z [---] followers, [----] engagements
"$PDSB $MRUS $BCAX Wake Up A Change Is Happening A key theme of the $PDSB Key Opinion Leader presentation yesterday was that change is happening yet some are slow to respond. Kevin Harrington reports that doctors like him that work with those who have Head and Neck cancer have observed a dramatic change over the past decade in the proportion of patients with HPV16 cancer. These are typically men. They tend to be younger than those with HPV negative cancer and have fewer other health problems. He hesitated to call this an epidemic but described it as a huge increase. Katharine A. Price who"
X Link 2025-06-18T13:59Z [---] followers, [---] engagements
"$PDSB $MRUS $BCAX Who is the Early Winner (Part 3) Confirmed ORR Another way to compare Petosemtamab and Ficera is using confirmed Objective Response Rate (CORR) values. Petosemtamab CORR CPS [--] 73% CPS 1-19 47% Ficera CORR CPS [--] 53% CPS 1-19 54% This data indicates that we may find that Ficera works better for those with lower CPS scores. That is a big deal because CPS scores tend to be lower for those in the HPV negative group. Petosemtamab may be more effective for those with high CPS scores. However since Petosemtamab has both HPV + and HPV - patients mixed in their numbers and these are"
X Link 2025-07-07T12:59Z [---] followers, [----] engagements
"If you look over the history of $PDSB you are going to have a really hard time finding a bad news event related to data. To my knowledge every study they have reported includes a good outcome. There was another good result last week. The stock price just does not match the data. Yes it takes more than data. Yet you do not find this kind of success after success without their being something of real substance there"
X Link 2025-07-16T16:44Z [---] followers, [---] engagements
"$PDSB $MRUS $BCAX Important Head & Neck Cancer Clinical Trials I decided to take a closer look at the clinical trials for three drugs that reported strong data for head and neck cancer at ASC0 [----]. Part of my focus is considering the implications of the inclusion and exclusion criteria. Versamune HPV16 For those seeking to enter the Versamune trial they need to have no prior treatment with a checkpoint inhibitor like Keytruda. That makes sense since some will be assigned to the control group where Keytruda alone is the treatment. Most of those entering this trial will have received"
X Link 2025-07-28T20:27Z [---] followers, [----] engagements
"$pdsb Quarterly Call -Reviewed recent study results that were previously reported -They continue to keep expenses relatively low There was no big news here. All is on track with phase [--] trial. They will submit phase [--] results for publication at the end of the year"
X Link 2025-08-13T12:29Z [---] followers, [----] engagements
"$SPRY $AQST Neffy - Headaches I have posted before about seeing a number of reports of persons experiencing really bad headaches after using Neffy. I continue to see these reports. My best guess is that the issue here is the absorption technology not the Epinephrine. Other nasal strays that use this technology have reported similar side effects. I was reminded of this today when this issue appeared in an AI box when I did a search for Neffy on Reddit (see below). It is difficult to determine the prevalence of this issue. Yet it could be a factor in some moving to Anaphylm when it is approved."
X Link 2025-08-17T15:06Z [---] followers, [----] engagements
"$PDSB It looks like PDSB just registered a shelf offering. This makes sense. It gives them flexibility to sell stock at a time they select. (They are not committed to sell all this stock.) Their current approach is to sell stock as needed to get through the phase [--] trial. They want to dilute as little as possible but fund this vital study. This lets them make small stock sales at opportune times"
X Link 2025-08-29T22:15Z [---] followers, [----] engagements
"$CAPR The Current Status $CAPR had a type A meeting with the FDA where they were able to make an extensive presentation and suggest options for a path forward with Deramiocel. My speculation is that this was well received by the FDA staff. It appears that the FDA staff around the table have been supportive of approval of Deramiocel throughout this process. Yet I am not aware of any reports that Prasad was present at the type A meeting. So the person who overrode and fired staff who stood their ground in support of Deramiocel will likely need to weigh in for there to be any clarity. Presumably"
X Link 2025-08-31T17:33Z [---] followers, [----] engagements
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