# ![@BiotechAutist Avatar](https://lunarcrush.com/gi/w:26/cr:twitter::897335219082203144.png) @BiotechAutist Biotech Autist

Biotech Autist posts on X about $rgnx, if you, short, money the most. They currently have [-----] followers and [---] posts still getting attention that total [-----] engagements in the last [--] hours.

### Engagements: [-----] [#](/creator/twitter::897335219082203144/interactions)
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- [--] Week [------] +206%
- [--] Month [------] -20%

### Mentions: [--] [#](/creator/twitter::897335219082203144/posts_active)
![Mentions Line Chart](https://lunarcrush.com/gi/w:600/cr:twitter::897335219082203144/c:line/m:posts_active.svg)


### Followers: [-----] [#](/creator/twitter::897335219082203144/followers)
![Followers Line Chart](https://lunarcrush.com/gi/w:600/cr:twitter::897335219082203144/c:line/m:followers.svg)

- [--] Week [-----] +8%
- [--] Month [-----] +31%

### CreatorRank: [---------] [#](/creator/twitter::897335219082203144/influencer_rank)
![CreatorRank Line Chart](https://lunarcrush.com/gi/w:600/cr:twitter::897335219082203144/c:line/m:influencer_rank.svg)

### Social Influence

**Social category influence**
[finance](/list/finance)  [technology brands](/list/technology-brands)  [ncaa football](/list/ncaa-football)  [stocks](/list/stocks)  [cryptocurrencies](/list/cryptocurrencies)  [social networks](/list/social-networks)  [currencies](/list/currencies) 

**Social topic influence**
[$rgnx](/topic/$rgnx) #4, [if you](/topic/if-you), [short](/topic/short), [money](/topic/money), [rare](/topic/rare), [$fbio](/topic/$fbio), [$otlk](/topic/$otlk), [debt](/topic/debt), [target](/topic/target), [lack of](/topic/lack-of)

**Top accounts mentioned or mentioned by**
[@as6708061](/creator/undefined) [@servetgm1](/creator/undefined) [@asamimes](/creator/undefined) [@brianskorney](/creator/undefined) [@leerinkpartners](/creator/undefined) [@clearstreetnews](/creator/undefined) [@tweetawaydk](/creator/undefined) [@fda](/creator/undefined) [@fluoxefuckboy](/creator/undefined) [@galaxyrover100](/creator/undefined) [@dacapital](/creator/undefined) [@quackingmo](/creator/undefined) [@kriveoko24676](/creator/undefined) [@aaronrosenblum5](/creator/undefined) [@houndcl](/creator/undefined) [@littlebun_bobby](/creator/undefined) [@johnporter10](/creator/undefined) [@bambossie81](/creator/undefined) [@anthonytayior](/creator/undefined) [@godelterminal](/creator/undefined)

**Top assets mentioned**
[Travere Therapeutics, Inc. Common Stock (TVTX)](/topic/$tvtx) [Mist (MIST)](/topic/$mist) [Hims & Hers Health, Inc. (HIMS)](/topic/$hims) [Robinhood Markets, Inc.  (HOOD)](/topic/$hood) [Alphabet Inc Class A (GOOGL)](/topic/$googl) [Taraxa (TARA)](/topic/$tara)
### Top Social Posts
Top posts by engagements in the last [--] hours

"🧵 $FBIO: The Mechanics of an Asymmetric Trade (Jan 14). I shorted the last PDUFA because of a single regulatory variable. I am aggressively LONG this one. That variable has flipped. The gate is open. And the market is mispricing the math by 50%. Here is the dissection. 👇 (1/10)"  
[X Link](https://x.com/BiotechAutist/status/2007089538611515801)  2026-01-02T14:00Z [----] followers, [----] engagements


"1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2014710981406957634)  2026-01-23T14:45Z [----] followers, 33.1K engagements


"@John_Porter10 FDA will not approve. It's a 351(a) with a missed SPA primary endpoint"  
[X Link](https://x.com/BiotechAutist/status/2003376310052385238)  2025-12-23T08:05Z [---] followers, [---] engagements


"Heres the situation: Vanda has been in a literal war with the FDA. The battleground Tradipitant (motion sickness). The issue FDA wanted a 9-month dog toxicity study. Vanda refused. They said: "No. We aren't killing beagles for this. We have enough data." (2/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835641594970439)  2025-12-30T02:57Z [---] followers, [---] engagements


"The FDA put a CLINICAL HOLD on long-term human studies. They said it was unsafe. In court the FDA explicitly stated Tradipitant showed "troubling indications of toxicity" in animals. They drew a line in the sand: "Do the dog study or you don't get the drug." (3/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835643427885512)  2025-12-30T02:57Z [---] followers, [---] engagements


"This terrified the FDA. They realized Vanda wasn't just a annoyanc. They were a litigation machine that could expose the agency's incompetence. Despite Vanda losing the Tradipitant case and the courts saying the FDA could demand the dog study the FDA CAPITULATED (6/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835649895563573)  2025-12-30T02:57Z [---] followers, [---] engagements


"On Dec [--] FDA suddenly "lifted the clinical hold" on Tradipitant. They waived the long-term dog study they SWORE was essential for safety. They folded. Their excuse Motion sickness is "acute" so the toxicity suddenly "doesn't matter" anymore. (7/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835651606884734)  2025-12-30T02:57Z [---] followers, [---] engagements


"Read between the lines. The FDA went from "troubling indications of toxicity" to "go ahead" with ZERO new dog studies. Vanda sued them into submission. They lost the battle (court) but won the war (policy). Totally unprecedented. (8/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835653074899183)  2025-12-30T02:57Z [---] followers, [---] engagements


"Why is this a buy NOW Because the PDUFA (approval decision) for Tradipitant in Motion Sickness is TOMORROW DEC [--]. The FDA just conceded the safety argument [--] weeks ago by lifting the hold. The path is clear. The tea leaves are reading 100% APPROVAL. (9/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835654849081495)  2025-12-30T02:57Z [---] followers, [---] engagements


"Under [--] U.S.C. 355(d) FDA MUST refuse approval if there is a "lack of substantial evidence." Outlook is asking FDA to ignore a failed SPA (Special Protocol Assessment). They signed a contract defining success (Week 8). They missed it. Now they want a participation trophy. (4/12)"  
[X Link](https://x.com/BiotechAutist/status/2006002394740502734)  2025-12-30T14:00Z [----] followers, [----] engagements


""But what about Retinal Thickness Mechanism of action" Stop. This is a 351(a) BLA. It must stand on its own data. You cannot copy-paste the "science of Avastin" to save a failed trial. Mechanistic data is exploratory. It cannot legally replace a failed primary endpoint. (5/12) https://twitter.com/i/web/status/2006002396439158913 https://twitter.com/i/web/status/2006002396439158913"  
[X Link](https://x.com/BiotechAutist/status/2006002396439158913)  2025-12-30T14:00Z [----] followers, [---] engagements


"Here is the death spiral nobody is talking about: The Avondale Note. Matures July [----]. There is a "Major Trigger Event" floor at $0.404. If the VWAP drops below that they can't pay in stock. They have to pay CASH. (7/12)"  
[X Link](https://x.com/BiotechAutist/status/2006002398624366640)  2025-12-30T14:00Z [---] followers, [---] engagements


"Guess what They don't have the cash. Cash on hand is $9M (plus recent ATM dumping). Burn is $15M/quarter. If this drops 70% on a CRL tomorrow (which it will) they enter a death spiral. Convertible debt holders will own the company. Equity goes to zero. (8/12)"  
[X Link](https://x.com/BiotechAutist/status/2006002399572328766)  2025-12-30T14:00Z [---] followers, [---] engagements


"My Prediction for Dec 31: CRL #3. Reason: "Lack of Substantial Evidence" (Again). Price Target: -70% to -80% drop. Support: None until $0.40. (11/12)"  
[X Link](https://x.com/BiotechAutist/status/2006002402365767801)  2025-12-30T14:00Z [---] followers, [----] engagements


"I am shorting this into the dirt. Logic over emotion. Statutes over bagholder dreams. Follow @BiotechAutist if you want to make money on regulatory arbitrage. Let's watch it burn. 🔥 (12/12)"  
[X Link](https://x.com/BiotechAutist/status/2006002403175281056)  2025-12-30T14:00Z [---] followers, [----] engagements


"You are assuming rational long-term strategy. This is short-term desperation. They can't afford a new trial. They can't pay the debt in cash. Their ONLY move is to bluff with a "re-analysis" and hope the FDA ignores its own laws. Its a Hail Mary to keep the stock above $0.40. Statutes "Productive Meetings." https://twitter.com/i/web/status/2006076071909736791 https://twitter.com/i/web/status/2006076071909736791"  
[X Link](https://x.com/BiotechAutist/status/2006076071909736791)  2025-12-30T18:53Z [---] followers, [---] engagements


"@BAMBossie81 I know very little about most of these. Only ones I follow closely are VNDA SNDX and MREO. I bought sndx back in July and sold it after a [--] percent pre-PDUFA run-up due to risk of competition from KURA. MREO is cooked. And VNDA is a buy"  
[X Link](https://x.com/BiotechAutist/status/2006125285352050895)  2025-12-30T22:08Z [---] followers, [---] engagements


"🚨 $VNDA APPROVED. I told you. This wasn't about science. It was about LEVERAGE. Vanda sued the FDA into submission. The regulator capitulated. If you were reading the charts you missed it. If you were reading the lawsuits like me you are printing money. I don't guess. I dissect. @BiotechAutist 🚨 $VNDA is the only ticker that matters rn. Forget everything else. This is the wildest setup I have ever seen in biotech. FDA decision tomorrow. [--] decisions in [--] days. And the backstory is absolute insanity. If you aren't watching this you hate money. 🧵👇(1/12) 🚨 $VNDA is the only ticker that"  
[X Link](https://x.com/BiotechAutist/status/2006143444453110073)  2025-12-30T23:20Z [---] followers, [----] engagements


"🚨 $OTLK DOWN 20% PRE-MARKET. The CRL isn't even out yet and the exit doors are already jammed. This isn't "retail derisking." This is institutional capital front-running the news. The smart money read the statute. The insiders know what a "Class 1" review really means. If you are panic-selling now you are late. If you are holding for a "miracle" you are about to be zeroed. Target: -80% by close. 📉 https://twitter.com/i/web/status/2006342105577177206 https://twitter.com/i/web/status/2006342105577177206"  
[X Link](https://x.com/BiotechAutist/status/2006342105577177206)  2025-12-31T12:30Z [---] followers, [---] engagements


"🚨 $OTLK DOWN 15% PRE-MARKET. The CRL isn't even out yet and the exit doors are already jammed. This isn't "retail derisking." This is institutional capital front-running the news. The smart money read the statute. The insiders know what a "Class 1" review really means. If you are panic-selling now you are late. If you are holding for a "miracle" you are about to be zeroed. Target: -80% by close. 📉 https://twitter.com/i/web/status/2006342909658894545 https://twitter.com/i/web/status/2006342909658894545"  
[X Link](https://x.com/BiotechAutist/status/2006342909658894545)  2025-12-31T12:33Z [---] followers, [----] engagements


"$OTLK CRL IS OUT I told you. Class [--] Review = No New Data. The bulls screamed "Approval." The statute screamed "Rejection." You cannot cure a failed primary endpoint with a "re-analysis." Target: -70% to -80%. The solvency crisis begins now. I don't guess. I dissect. 📉 🚨 WARNING 🚨 If you are long $OTLK into tomorrows PDUFA you are walking into a buzzsaw. The bulls scream "Class [--] = Approval." They are wrong. This is a regulatory trap. I am shorting it. Here is why a 70-80% drop is the only logical outcome. 🧵👇 (1/12) 🚨 WARNING 🚨 If you are long $OTLK into tomorrows PDUFA you are walking"  
[X Link](https://x.com/BiotechAutist/status/2006477230936043580)  2025-12-31T21:27Z [---] followers, [----] engagements


"🧵 The $OTLK Autopsy: Anatomy of my -70% Call. They called me a "spin trader." I said: The Statute mandates rejection. I said: Zero. Warned you at $1.50. Target was -80%. Reality: -70%. I don't guess. I dissect. Receipts & Lesson below. 👇 (1/7) 🚨 WARNING 🚨 If you are long $OTLK into tomorrows PDUFA you are walking into a buzzsaw. The bulls scream "Class [--] = Approval." They are wrong. This is a regulatory trap. I am shorting it. Here is why a 70-80% drop is the only logical outcome. 🧵👇 (1/12) 🚨 WARNING 🚨 If you are long $OTLK into tomorrows PDUFA you are walking into a buzzsaw. The"  
[X Link](https://x.com/BiotechAutist/status/2006516144782340415)  2026-01-01T00:01Z [---] followers, [----] engagements


"What's Next ✅ $VNDA (Long) ✅ $OTLK (Short) [--] perfect calls in [--] hours. My next call will be $FBIO The next asymmetric trade is loading. Stop gambling. Regulatory Arbitrage. Follow @BiotechAutist. RT the first tweet 🔁 if you want more calls like this (7/7)"  
[X Link](https://x.com/BiotechAutist/status/2006516181289808059)  2026-01-01T00:01Z [---] followers, [----] engagements


"@FluoxeFuckboy Robinhood. Google: "how to start level [--] options trading on Robinhood". Buy puts to short"  
[X Link](https://x.com/BiotechAutist/status/2006811915864211889)  2026-01-01T19:37Z [---] followers, [--] engagements


"1. The History (The Short) Last time I predicted the CRL. Why: Zydus (the manufacturer) had a Warning Letter for glass contamination. The Edge: I read the FDA inspection report while others read the press release. (Receipts attached). (2/10)"  
[X Link](https://x.com/BiotechAutist/status/2007089539521671320)  2026-01-02T14:00Z [---] followers, [----] engagements


"2. The Pivot (The Long) The script has flipped for Jan [--]. Old Status: Warning Letter ❌ New Status: VAI (Voluntary Action Indicated) ✅ The FDA has officially cleared the facility. Crucially the Class [--] Review implies no new inspection is needed per MAPP policy (3/10)"  
[X Link](https://x.com/BiotechAutist/status/2007089541606150503)  2026-01-02T14:00Z [---] followers, [---] engagements


"3. The Cash Math (The PRV) Approval = Priority Review Voucher (PRV) for Cyprium. $FBIO owns 73.9% of Cyprium. Gross PRV Value: $152.5M (midpoint of comps). Net to FBIO: $112M (after fees). Cash Per Share: $3.08. The Arbitrage: Current Price: $3.66. You are effectively buying the entire operating business + pipeline for $0.58. (4/10) https://twitter.com/i/web/status/2007089542629634212 https://twitter.com/i/web/status/2007089542629634212"  
[X Link](https://x.com/BiotechAutist/status/2007089542629634212)  2026-01-02T14:00Z [----] followers, [----] engagements


"4. The Alpha: The "Overhang" Myth Everyone fears $MIST [---] (a stock that crashed on approval due to dilution). They are wrong. I ran the Overhang Index to prove it. (Immediate Supply) (Common Outstanding) $MIST Overhang: 100% (Warrants Float). $FBIO Overhang: 42%. Result: $FBIOs supply pressure is mathematically only 40% as bad as MISTs. The float can move. (5/10) https://twitter.com/i/web/status/2007089543728496834 https://twitter.com/i/web/status/2007089543728496834"  
[X Link](https://x.com/BiotechAutist/status/2007089543728496834)  2026-01-02T14:00Z [----] followers, [----] engagements


"5. The Circuit Breaker ⚡ Also $MIST dropped because they needed to spend money to launch. $FBIO is receiving a check for double its market cap. The PRV Check pays off the debt. The insolvency thesis dies the moment the wire hits. (6/10)"  
[X Link](https://x.com/BiotechAutist/status/2007089544714125578)  2026-01-02T14:00Z [----] followers, [----] engagements


"6. Dealer Positioning (Gamma) The tape is primed. Total Delta Shares: 894k Dealer Hedge Demand: 266k shares buy demand per $1 move by the morning of approval. This creates a mechanical bid. Dealers will chase the price up to stay neutral. (7/10)"  
[X Link](https://x.com/BiotechAutist/status/2007089545834111185)  2026-01-02T14:00Z [----] followers, [----] engagements


"7. The Forecast (Showing My Work) Based on the Float (23.4M) and Short Interest (3.6M) elasticity here are my price targets: Current price: $3.66 Fair Value (Undiluted): $5.51 (Base + Cash) Jan [--] AM Peak: $6.74 Driven by Short Cover + Gamma Squeeze chasing the open. Close: $5.29 Driven by dilution soak/profit taking. I am playing the AM wick. 84% upside if you time it right. (8/10) https://twitter.com/i/web/status/2007089546987532740 https://twitter.com/i/web/status/2007089546987532740"  
[X Link](https://x.com/BiotechAutist/status/2007089546987532740)  2026-01-02T14:00Z [----] followers, [----] engagements


"9. The Setup Because of the gamma profile expect extreme volatility at the open. The Trap: Buying the top of the 10am wick when dealers are capping the move. The Edge: Buying the re-rate before the crowd realizes the debt is effectively zero. If you are playing the squeeze be fast. If you are playing the valuation be patient. (9/10) https://twitter.com/i/web/status/2007089548145070120 https://twitter.com/i/web/status/2007089548145070120"  
[X Link](https://x.com/BiotechAutist/status/2007089548145070120)  2026-01-02T14:00Z [---] followers, [----] engagements


"CNPVs arent transferable/sellable so they dont add supply to the tradable PRV market. The only real scarcity swing is RPD-PRV reauthorization which is still Senate TBD and mostly impacts future issuance. For $FBIO/$CUTX Id still anchor PRV value to recent prints ($150160M) unless we see actual supply ramp. https://twitter.com/i/web/status/2007115479496745441 https://twitter.com/i/web/status/2007115479496745441"  
[X Link](https://x.com/BiotechAutist/status/2007115479496745441)  2026-01-02T15:43Z [---] followers, [---] engagements


"@AS6708061 Profit taking. I bought the dip"  
[X Link](https://x.com/BiotechAutist/status/2007281191003812332)  2026-01-03T02:41Z [---] followers, [---] engagements


"@AS6708061 I will but I will probably sell most of it after Hetlioz make a few other trades buy it back after February earnings then ride the Bysanti bump"  
[X Link](https://x.com/BiotechAutist/status/2007413223017054318)  2026-01-03T11:26Z [---] followers, [---] engagements


"@servet_gm1 @AS6708061 Inbox is open. Tell me about [--] or [--] stocks that catch your attention and I'll let you know what I know. Goes for anyone btw"  
[X Link](https://x.com/BiotechAutist/status/2008113949451923460)  2026-01-05T09:50Z [---] followers, [---] engagements


"@Galaxyrover100 You're right. P2 readouts for ald and aud coming this year my bad"  
[X Link](https://x.com/BiotechAutist/status/2008232301541683575)  2026-01-05T17:41Z [---] followers, [--] engagements


"🧵 $TVTX: The Market is Hallucinating The market is betting on unmet need I am betting on the Code of Federal Regulations I am Short. The drug failed its functional endpoint FDA laws are clear: No substantial evidence = No approval. Here is the Regulatory Autopsy. 👇 (1/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286690125685190)  2026-01-05T21:17Z [----] followers, [----] engagements


"1. The Nightmare Pattern DUPLEX committed the cardinal sin: ✅ Biomarker (Proteinuria): Improved ❌ Functional Endpoint (eGFR): FAILED If FDA approves they are saying: "We trust the biomarker even though the actual function didn't improve." Massive regulatory leap. (2/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286691685986419)  2026-01-05T21:17Z [----] followers, [----] engagements


"2. The FDA Already Said "No" 🛑 Dec [----] Type C meeting: "The two-year DUPLEX results alone are not sufficient to support an sNDA submission." Unless Travere found magical new data since Dec '23 (they didn't) the default setting is REJECT. Prior art matters. (3/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286694114550130)  2026-01-05T21:17Z [---] followers, [---] engagements


"3. The Fake Data Bridge 🌉 Travere links "Proteinuria Thresholds" to "Kidney Failure." Look at their slide: It's post-randomization (breaks the trial). The Confidence Interval is [---] [---]. [---] includes "Harm." To an FDA statistician this isn't evidence. Its noise. (4/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286696291352846)  2026-01-05T21:17Z [----] followers, [---] engagements


"4. The Wrong Endpoint 🎯 Travere uses FPRE (Partial Remission) FDA guidance prefers Complete Remission for traditional approval They are trying to "upgrade" a partial surrogate into a Full Approval claim despite eGFR failing to corroborate. You can't have both be weak. (5/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286699407773963)  2026-01-05T21:17Z [----] followers, [---] engagements


"5. The "Active Control" Excuse 🤷♂ Travere argues: "Irbesartan just worked too well" FDA Response: "Not our problem." The standard is "Substantial Evidence." If you fail to beat the control on function you have not demonstrated it. "The test was hard" is not a defense. (6/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286702012440767)  2026-01-05T21:17Z [----] followers, [---] engagements


"6. The AdCom Trap 🪤 "Cancelled AdCom = Bullish" Wrong. Ask $CAPR investors about July. Removal means FDA doesn't need advice. That can mean "Straightforward Approval." It can also mean "Straightforward CRL." Given the failed eGFR endpoint a CRL is the clean call. (7/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286704520556848)  2026-01-05T21:17Z [----] followers, [----] engagements


"7. The Code of Federal Regulations ⚖ Laws are clear: FDA must refuse approval if there is lack of "Substantial Evidence." Unmet need influences risk tolerance but it does not replace the evidence standard. Failed eGFR slope. Weak stats. Prior warnings. = CRL. (8/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286707548852601)  2026-01-05T21:17Z [----] followers, [----] engagements


"8. The Verdict The FDA isn't a charity. They don't give approvals for "trying hard." They demand evidence. $TVTX doesn't have it. Jan [--] isn't a gamble. It's an execution. I'm not guessing. I'm waiting for the wire. Prediction: CRL. Follow @BiotechAutist. (9/9)"  
[X Link](https://x.com/BiotechAutist/status/2008286709822177612)  2026-01-05T21:17Z [----] followers, [----] engagements


"@AS6708061 I'd estimate an initial gap down to $23 then close around $25"  
[X Link](https://x.com/BiotechAutist/status/2008294288309010602)  2026-01-05T21:47Z [----] followers, [---] engagements


"This actually cuts against FILSPARI not for it. Dimerix got explicit prospective FDA permission to run proteinuria as the PRIMARY endpoint for traditional approval. Travere did not. DUPLEX was built around eGFR slope and it failed. You dont get to retroactively swap primaries after missing. This shows FDAs preference going forward not forgiveness after the fact. https://twitter.com/i/web/status/2008303811610234986 https://twitter.com/i/web/status/2008303811610234986"  
[X Link](https://x.com/BiotechAutist/status/2008303811610234986)  2026-01-05T22:25Z [----] followers, [---] engagements


"Because Exondys [--] and Aduhelm were Accelerated Approval cases. Under Accelerated Approval FDA can approve on a reasonably likely surrogate (21 CFR [-------] / [--] USC 356) then require confirmatory proof or withdraw if it fails. FILSPARI FSGS is not filed that way. Traveres sNDA is explicitly for traditional approval (505(b)(1)). Traditional approval is governed by [--] USC 355(d): FDA needs substantial evidence. In DUPLEX the primary endpoint for the final 108-week analysis was eGFR slope and it missed. Proteinuria was prespecified but as an interim surrogate not the primary at the final"  
[X Link](https://x.com/BiotechAutist/status/2008360038746771902)  2026-01-06T02:08Z [----] followers, [---] engagements


"No. Substantial evidence didnt change. That standard is set in statute (21 USC 355(d)) and it still means evidence from adequate and well controlled investigations. PARASOL can influence what FDA is willing to accept as a surrogate but it does not rewrite the legal bar. Also FDA accepting an sNDA just means it was filed and is reviewable. It is not a signal that the evidence meets SEE. Traveres own release still admits DUPLEX missed the primary eGFR slope endpoint which is why this is still a hard case. https://twitter.com/i/web/status/2008399420186845448"  
[X Link](https://x.com/BiotechAutist/status/2008399420186845448)  2026-01-06T04:45Z [---] followers, [--] engagements


"@servet_gm1 @AS6708061 Just looked into $tara. For the 1H [----] FDA meeting I predict it will be positive but FDA will require a heavier single-arm (bigger N) causing a decent bump in stock price"  
[X Link](https://x.com/BiotechAutist/status/2008737303930564669)  2026-01-07T03:07Z [----] followers, [---] engagements


"@servet_gm1 @AS6708061 Nope. Just someone who actually reads the filings and FDA receipts nobody else bothers to read"  
[X Link](https://x.com/BiotechAutist/status/2008756835461837107)  2026-01-07T04:25Z [----] followers, [---] engagements


"@AS6708061 @servet_gm1 And yes [--] dollars is the intrinsic value"  
[X Link](https://x.com/BiotechAutist/status/2008783926756864344)  2026-01-07T06:13Z [---] followers, [---] engagements


"@AS6708061 @servet_gm1 That can very often be the max profit strategy"  
[X Link](https://x.com/BiotechAutist/status/2008785928253567425)  2026-01-07T06:21Z [---] followers, [---] engagements


"Exactly. Long term VNDA shareholders HATE the CEO. He rejected a buyout offer at [--] dollars when the stock was at $5 and they hate his legal strategy of constantly using shareholder money to fund lawsuits against the FDA. I think his strategy was genius and clearly paid off but shareholders disagree. https://twitter.com/i/web/status/2008798789004370266 https://twitter.com/i/web/status/2008798789004370266"  
[X Link](https://x.com/BiotechAutist/status/2008798789004370266)  2026-01-07T07:12Z [---] followers, [---] engagements


"@Anthony_TayIor @GodelTerminal PARASOL didnt exist back then. True. But it doesnt override the sponsors SAP: DUPLEX used hierarchical gatekeeping. Once the primary failed later endpoints are nominal/supportive. Workshops cant retroactively make that decision-grade SEE"  
[X Link](https://x.com/BiotechAutist/status/2008958029052440799)  2026-01-07T17:44Z [---] followers, [--] engagements


"$ATRA will get FDA approval tomorrow. Manufacturing is massively derisked their Memphis site cleared back-to-back EMA + FDA CBER inspections in July and October after upgrades to CCS/QMS/sterility assurance. Easy money IMO"  
[X Link](https://x.com/BiotechAutist/status/2009287547352973767)  2026-01-08T15:34Z [----] followers, 10.1K engagements


"@AS6708061 @servet_gm1 Yes. My research so far makes me think they'll get fda approved but I still need to do more research and make sure I'm not missing something"  
[X Link](https://x.com/BiotechAutist/status/2009405322633314754)  2026-01-08T23:22Z [---] followers, [---] engagements


"@AS6708061 @servet_gm1 Sorry to hear 😕 This is the annoying part of biotech trades: price often moves before the decision because positioning shifts. I didnt call AQST but ATRA dumping pre-announcement is consistent with de-risking and stop-loss sweeps. Not advice just how these setups behave"  
[X Link](https://x.com/BiotechAutist/status/2009645500467712061)  2026-01-09T15:16Z [---] followers, [---] engagements


"@xpand_ur_mind Sell the news + stop loss triggers. It will get uglier before it gets better"  
[X Link](https://x.com/BiotechAutist/status/2009646100177924164)  2026-01-09T15:19Z [----] followers, [---] engagements


"$TVTX -30% After Hours. No CRL yet officially but the PR just leaked the kill shot. Buried in the update they admitted the FDA asked them to: ".further characterize the clinical benefit of FILSPARI" Translation: The FDA is still questioning the core efficacy ("clinical benefit") on the eve of the deadline. You don't get asked to prove the drug works [--] hours before approval. You get asked that when the agency is building the case for a rejection. The trade is over. The letter is just a formality. https://twitter.com/i/web/status/2010856311718887457"  
[X Link](https://x.com/BiotechAutist/status/2010856311718887457)  2026-01-12T23:27Z [----] followers, 13.4K engagements


"@AS6708061 "The company hinted that it would be a CRL but nothing is official yet.""  
[X Link](https://x.com/BiotechAutist/status/2010870178947506440)  2026-01-13T00:23Z [----] followers, [---] engagements


"@TweetAwayDK Well the FDA has surprised me before. But if it was just a labeling thing I think they would have said that"  
[X Link](https://x.com/BiotechAutist/status/2010883937577681384)  2026-01-13T01:17Z [----] followers, [---] engagements


"@TweetAwayDK FDA often still asks late-cycle questions even when leaning CRL to finish the administrative record and support a defensible action letter"  
[X Link](https://x.com/BiotechAutist/status/2010889671245476147)  2026-01-13T01:40Z [----] followers, [---] engagements


"5. The Silence 🔇 The approval is here. The PRV announcement is not. If they had the voucher it would be line [--] of the PR. The silence confirms the reality: Approval granted. PRV denied based on the Previously Approved Moiety clause. (6/8)"  
[X Link](https://x.com/BiotechAutist/status/2010967051108532440)  2026-01-13T06:48Z [----] followers, [---] engagements


"6. The Pivot Without the PRV the $112M cash injection is a ghost. Old Thesis: Cash Debt. Reality: Debt Cash. The "Solvency Event" is gone. We are holding a debt-laden shell with a drug that has no voucher attached. (7/8)"  
[X Link](https://x.com/BiotechAutist/status/2010967053453103293)  2026-01-13T06:48Z [----] followers, [----] engagements


"7. The Exit I don't hold bags on hope. The catalyst passed. The PRV failed. The "Solvency Event" is dead. I am taking the L and clearing the book. See you on the next one. (8/8)"  
[X Link](https://x.com/BiotechAutist/status/2010967056154239431)  2026-01-13T06:48Z [----] followers, [----] engagements


"@Cattletech Probably not. I don't think it's gonna crash"  
[X Link](https://x.com/BiotechAutist/status/2010975916730532056)  2026-01-13T07:23Z [----] followers, [---] engagements


"@Themillion21011"  
[X Link](https://x.com/BiotechAutist/status/2011003978826351017)  2026-01-13T09:14Z [----] followers, [---] engagements


"I love you @FDA"  
[X Link](https://x.com/BiotechAutist/status/2011171129243656260)  2026-01-13T20:18Z [----] followers, [----] engagements


"@DA_Capital_ @FDA Only puts. Got em for dirt cheap"  
[X Link](https://x.com/BiotechAutist/status/2011586312680460316)  2026-01-14T23:48Z [----] followers, [---] engagements


"@AS6708061 @DA_Capital_ @FDA Nope. It went great. Sold them and made $23k"  
[X Link](https://x.com/BiotechAutist/status/2011604266658750945)  2026-01-15T01:00Z [----] followers, [---] engagements


"🧵 $RGNX: The entire thesis in one line: [--] CFR [---] Subpart E Bears say the trial is too small (N=13). The Statute says it isn't. You are either trading the noise or you are trading the Law. I'm trading the Law. Prediction: APPROVED. 👇 (1/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170327451685015)  2026-01-16T14:29Z [----] followers, [----] engagements


"1. The Legal Framework Most investors don't read statutes. [--] CFR [------] authorizes approval for serious/rare diseases based on a surrogate endpoint "reasonably likely to predict clinical benefit." It doesn't require "Definitive Proof." It requires "Likelihood." (2/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170329058156644)  2026-01-16T14:29Z [----] followers, [---] engagements


"2. The "Aligned" Surrogate The biggest risk in AA is the FDA disagreeing with the endpoint. That risk is off the table. In the Pre-BLA meeting FDA remained "aligned" on using CSF HS D2S6. You don't align on a surrogate if you doubt the biology. (3/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170331394388444)  2026-01-16T14:29Z [----] followers, [---] engagements


"5. The "Small N" Myth "But N=13 is too small" False. FDA Guidance (May 2014) explicitly states that in rare diseases "single-arm trials can be an important option." AA exists precisely because gathering large-scale data takes too long. It's a feature not a bug. (6/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170337677431011)  2026-01-16T14:29Z [----] followers, [---] engagements


"6. The "Clean" Inspection While the market fretted FDA cleared the facilities. Pre-License Inspection: Completed. Bioresearch Monitoring: Completed. Observations: NONE. Getting a "No Observations" report is the strongest de-risking signal in the public record. (7/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170340273676527)  2026-01-16T14:29Z [----] followers, [---] engagements


"13. Connecting the Dots Aligned Surrogate (Pre-BLA). Clean Inspections (No observations). Data Extension (FDA asking for data). No Safety Signals. Legal Framework (AA fits). The evidence stack is undeniable. (13/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170355880718712)  2026-01-16T14:29Z [----] followers, [---] engagements


"14. The Call Bears are betting on a surprise. Bulls are betting on the public record. The regulatory path has been followed to the letter. FDA is doing exactly what the AA pathway mandates for a rare disease. Prediction: Accelerated Approval. (14/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170358388916709)  2026-01-16T14:29Z [----] followers, [---] engagements


"Hey Retail: Your "Technical Analysis" is just astrology for broke people. Stop trading like a moron. Start reading the Federal Register. I can't fix your IQ but I can fix your PnL. Follow @BiotechAutist if you want to stop donating your portfolio to the pros. (15/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170360393805969)  2026-01-16T14:29Z [----] followers, [----] engagements


"@AS6708061 $20"  
[X Link](https://x.com/BiotechAutist/status/2012172791290691878)  2026-01-16T14:39Z [----] followers, [---] engagements


"The barometer already printed for $QURE: FDA said the current data are unlikely to support a BLA as primary evidence. A Type A is escalation after a negative stance. Base case is FDA gives requirements for additional data which pushes timelines out and hurts the near-term bull case. https://twitter.com/i/web/status/2012179884689236272 https://twitter.com/i/web/status/2012179884689236272"  
[X Link](https://x.com/BiotechAutist/status/2012179884689236272)  2026-01-16T15:07Z [----] followers, [---] engagements


"FBIO dumped because it was cash-strapped overlevered and [--] %+ diluted: only $38 M parent cash $48 M debt [--] M warrants on [--] M shares and high-interest notes. RGNX has $302 M cash zero bank debt [---] % warrants and an unused $150 M ATM. Not distressed no immediate financing risk. So a violent FBIO-style post-approval bleed is unlikely. https://twitter.com/i/web/status/2012194464916488212 https://twitter.com/i/web/status/2012194464916488212"  
[X Link](https://x.com/BiotechAutist/status/2012194464916488212)  2026-01-16T16:05Z [----] followers, [---] engagements


"@dimoblov I have the same ones. I'll probably sell a majority of them before approval on a day when premiums are juicy then buy stock sell most of it pre market"  
[X Link](https://x.com/BiotechAutist/status/2012292748838089076)  2026-01-16T22:35Z [----] followers, [---] engagements


"@FluoxeFuckboy @capybaraReborn I'm long $RGNX"  
[X Link](https://x.com/BiotechAutist/status/2013880015838925296)  2026-01-21T07:43Z [----] followers, [---] engagements


"@quackingmo Discussed agreed. Every sponsor discusses confirmatory plans with FDA. Unless you have SPA or explicit FDA concurred on design/endpoints/stat plan that quote is basically PR boilerplate"  
[X Link](https://x.com/BiotechAutist/status/2014844094908915907)  2026-01-23T23:34Z [----] followers, [---] engagements


"Youre mixing three different ideas that dont actually substitute for each other: CMC/no observations is great but it only clears the manufacturing gate. AA still has separate gates: (a) is the surrogate reasonably likely and (b) is there a credible confirmatory program that can verify and describe clinical benefit in a way FDA can defend in an action letter. No new data requests isnt a green light. FDA can stop asking once they have enough to decide yes or no. A lack of further asks doesnt tell you the conclusion it just tells you the record is complete enough to write the letter. The"  
[X Link](https://x.com/BiotechAutist/status/2014867465373700458)  2026-01-24T01:06Z [----] followers, [---] engagements


"I have sold my entire $RGNX position and will probably flip short soon. Noticing some serious incompetence from this company. Longer thread coming stay tuned"  
[X Link](https://x.com/BiotechAutist/status/2014444824162684931)  2026-01-22T21:07Z [----] followers, [----] engagements


"@KriveOko24676 You're debating semantics while down 35%. I don't argue with my exit liquidity. I just accept the wire transfer. Thanks for the donation. 🤝"  
[X Link](https://x.com/BiotechAutist/status/2016507267781210523)  2026-01-28T13:42Z [----] followers, [---] engagements


"$RGNX @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews Youre analysts. Youre paid to be objective and impartial. Stop using delay as a euphemism when you KNOW retail hears delay and doesnt hear CRL. Youre leading people into a trap. You only get ONE PDUFA extension per review cycle. They already used it. There is no second extension. So around Feb [--] this delay framing is a CRL setup. If CRL is your base case say CRL. Retail deserves plain English not analyst word games"  
[X Link](https://x.com/anyuser/status/2016990829626134810)  2026-01-29T21:44Z [----] followers, [----] engagements


"@AaronRosenblum5 @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews True. But I don't think they're predicting FDA staffing issues"  
[X Link](https://x.com/BiotechAutist/status/2016993928017244250)  2026-01-29T21:56Z [----] followers, [---] engagements


"@AaronRosenblum5 @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews Very true. $KALV also. But I dont think thats what they mean here when they say delay after a tumor/hold. Theyre not talking about a generic FDA timing miss. Theyre using delay as a nicer word for CRL and retail hears delay and thinks safe.""  
[X Link](https://x.com/BiotechAutist/status/2016996040230969768)  2026-01-29T22:05Z [----] followers, [---] engagements


"@mike98572986 @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews I get what youre saying but thats not really how it works. The sponsor can't control extensions or whats a major amendment. FDA always does. And the FDAs own PDUFA goals letter is explicit: Only one extension can be given per review cycle"  
[X Link](https://x.com/BiotechAutist/status/2017002481880822216)  2026-01-29T22:30Z [----] followers, [---] engagements


"@BsmtInChief @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews Your framing is off. FDA doesnt set a new date like its a dentist appointment. If its not approvable as filed because the hold blocks what they need you get a CRL and you come back when youve got what they want"  
[X Link](https://x.com/BiotechAutist/status/2017021610310402365)  2026-01-29T23:46Z [----] followers, [---] engagements


"You definitely missed it. The tape has been screaming $150M+ all year. Here are the confirmed prints from the last [--] months: Bavarian Nordic: $160M (June '25) Abeona: $155M (May '25) Zevra: $150M (Feb '25) Ipsen: $158M (Aug '24) The "Political Favors" (CNPV) aren't denting the price. The program sunsetted. Scarcity is winning. The floor is $150M. https://twitter.com/i/web/status/2007112215988498572 https://twitter.com/i/web/status/2007112215988498572"  
[X Link](https://x.com/BiotechAutist/status/2007112215988498572)  2026-01-02T15:30Z [----] followers, [---] engagements


"CMC looks meaningfully de-risked now. Charles Rivers Memphis CDMO (the site implicated before) says it cleared back-to-back EMA + FDA CBER inspections in July and October [----] after [----] upgrades to CCS/QMS/sterility assurance. High probability of approval. Id expect a solid pop (2535%). https://twitter.com/i/web/status/2009078583247933445 https://twitter.com/i/web/status/2009078583247933445"  
[X Link](https://x.com/BiotechAutist/status/2009078583247933445)  2026-01-08T01:43Z [----] followers, [---] engagements


"@blessedpapa73 @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews $ETON I'm still looking into their CMC. I'll probably make a post later. IDK about $KYTK why are you watching them"  
[X Link](https://x.com/BiotechAutist/status/2018072584416346322)  2026-02-01T21:22Z [----] followers, [---] engagements


"10. Summary The VAI status was the smoking gun. The FDA block is gone. The $150M check is already printed. The market is handing you a solvent cash-rich company for the price of a bankrupt one. This isn't a gamble. It is an arbitrage. Follow @BiotechAutist"  
[X Link](https://x.com/BiotechAutist/status/2007089549227307491)  2026-01-02T14:00Z [----] followers, [----] engagements


"🧵 $FBIO: I Was Wrong. The thesis is dead. I missed a critical regulatory kill-switch. ZYCUBO is approved. But the $150M PRV is missing. Its never coming. I built a thesis on "Free Money." I walked into a Statutory Trap. Here is the autopsy. 👇 (1/8)"  
[X Link](https://x.com/BiotechAutist/status/2010967038856958059)  2026-01-13T06:47Z [----] followers, 10.7K engagements


"To the retail traders who are still long $HIMS You aren't "fighting the FDA." You are voluntarily funding a hedge fund manager's ski trip to Aspen. Selling unapproved drugs isn't a moat. It's a felony. Follow @BiotechAutist to stop donating your portfolio"  
[X Link](https://x.com/anyuser/status/2019924315026657692)  2026-02-07T00:00Z [----] followers, [----] engagements


"3. The "Priority" Signal FDA accepted the BLA explicitly "seeking accelerated approval" and granted Priority Review. If FDA believed the dataset (N=13) was insufficient for filing they would have issued a Refusal to File (RTF). They didn't. They accelerated it. (4/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170333520855529)  2026-01-16T14:29Z [----] followers, [---] engagements


"4. The Extension Logic PDUFA extensions happen when a sponsor submits a "Major Amendment" (new data) late in the cycle. Regenxbio submitted updated N=13 data. The FDA needs time to analyze it. This is procedural due diligence not a sign of a broken file. (5/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170335588590033)  2026-01-16T14:29Z [----] followers, [---] engagements


"8. The Safety Calculus From the filings: "No safety-related concerns have been raised by FDA during the BLA review." If there is no safety signal and manufacturing is clean the only variable is Efficacy. And for AA efficacy only needs to be "Reasonably Likely." (9/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170345025872074)  2026-01-16T14:29Z [----] followers, [---] engagements


"9. The Regulatory Flex The Confirmatory Study (RGX-121-3102) is the ultimate bull signal. FDA agreed to verify benefit with just [--] new patients + the pivotal data. If they were skeptical they'd demand a large randomized trial. Instead they greenlit a victory lap. (10/15)"  
[X Link](https://x.com/BiotechAutist/status/2012170347760509365)  2026-01-16T14:29Z [----] followers, [---] engagements


"@houndcl RGX-121 related"  
[X Link](https://x.com/BiotechAutist/status/2014448066259026120)  2026-01-22T21:20Z [----] followers, [----] engagements


"Mepsevii isn't your precedent. It had a randomized delayed-start (placebo exposure) pivotal plus an FDA-required longitudinal postmarketing study with years of follow-up and [--] new patients. RGX-121s confirmatory is N=2 (supplemented with the pivotal 13). Those are not comparable confirmatory programs. https://twitter.com/i/web/status/2014850199487685038 https://twitter.com/i/web/status/2014850199487685038"  
[X Link](https://x.com/BiotechAutist/status/2014850199487685038)  2026-01-23T23:58Z [----] followers, [---] engagements


"Unethical to randomize doesn't mean there's no need to prove effect. FDA will accept non-randomized designs in ultra-rare but then they demand credible attribution (pre-specified external natural history controls objective endpoints adjudication sensitivity analyses). "We cant randomize" doesnt magically make a thin confirmatory package OK. ATRA is the reminder: FDA will still CRL if they cant write a defensible treatment-effect story"  
[X Link](https://x.com/BiotechAutist/status/2015625166177415237)  2026-01-26T03:17Z [----] followers, [---] engagements


"$RGNX bulls: this is why I dont trade fairy tales. FDA clinical hold on REGENXBIO gene therapy programs including RGX-121 after a brain tumor case. When I say FDA risk is real this is the receipt. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2016499769225416850)  2026-01-28T13:13Z [----] followers, 10.3K engagements


"Sorry for the late response. RGNX CRL is bad readthrough for any CSF HS + natural history AA. FDA questioned neuronopathic population definition natural history comparability and CSF HS D2S6 as a surrogate. SPRB has prior FDA Type C alignment for HS-NRE plus longer-term data but its not a free pass. Key risk is still population control rigor and confirmatory credibility. https://twitter.com/i/web/status/2021472131633082541 https://twitter.com/i/web/status/2021472131633082541"  
[X Link](https://x.com/BiotechAutist/status/2021472131633082541)  2026-02-11T06:31Z [----] followers, [---] engagements


"Fair point Bob I get the argument that other products matter more. The problem is a CNS AAV safety CRL does not just reprice RGX-121. It raises perceived platform and regulatory risk extends timelines and can trigger mandate driven de-risking given the heavy institutional ownership. It also removes near term PRV optionality. That setup likely still drives another leg down even if attention has shifted. https://twitter.com/i/web/status/2020629941721981385 https://twitter.com/i/web/status/2020629941721981385"  
[X Link](https://x.com/BiotechAutist/status/2020629941721981385)  2026-02-08T22:44Z [----] followers, [---] engagements


"@AS6708061 @servet_gm1 Agreed efficacy wise its vanilla basically chasing Spevigo. The only real edge is safety. If FDA sees the lack of DRESS/severe reactions as a significant improvement over the incumbent ordinary might actually win. Don't really have any bold predictions though"  
[X Link](https://x.com/BiotechAutist/status/2008893515619618943)  2026-01-07T13:28Z [----] followers, [---] engagements


"🚨 $VNDA is the only ticker that matters rn. Forget everything else. This is the wildest setup I have ever seen in biotech. FDA decision tomorrow. [--] decisions in [--] days. And the backstory is absolute insanity. If you aren't watching this you hate money. 🧵👇(1/12)"  
[X Link](https://x.com/BiotechAutist/status/2005835638658973755)  2025-12-30T02:57Z [----] followers, [----] engagements


"$RGNX Turns out single arm n=13 wasn't good enough. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2020979990750183894)  2026-02-09T21:55Z [----] followers, 10.5K engagements


"4/ Its the communication that FDA has identified deficiencies that preclude further discussion of labeling. That is regulatory code for: this is not approvable as filed"  
[X Link](https://x.com/BiotechAutist/status/2021632838076977237)  2026-02-11T17:10Z [----] followers, [---] engagements


"5/ The market knows how to price that. Look at $AQST. They disclosed FDA identified deficiencies that precluded labeling discussions during review. Stock got crushed about 40% premarket. Thats the template"  
[X Link](https://x.com/BiotechAutist/status/2021632838945161672)  2026-02-11T17:10Z [----] followers, [---] engagements


"Because a formal deficiencies preclude labeling discussion notice isnt routine back-and-forth. It directly signals the application is not approvable in its current form. Thats a material regulatory event for a public company. AQST wasnt a unicorn. When FDA formally shifts posture like that companies disclose. Sitting on something that effectively telegraphs a likely CRL is not realistic"  
[X Link](https://x.com/BiotechAutist/status/2021639385091805665)  2026-02-11T17:36Z [----] followers, [---] engagements


"$OTLK Called it. I'm short $OTLK. FDA will not approve. -80% by next month. last CRL was efficacy and this resubmission brings no new data only re-arguing the same file. screenshot this. I'm short $OTLK. FDA will not approve. -80% by next month. last CRL was efficacy and this resubmission brings no new data only re-arguing the same file. screenshot this"  
[X Link](https://x.com/anyuser/status/2006480861282422960)  2025-12-31T21:41Z [----] followers, 20.3K engagements


"I'm short $OTLK. FDA will not approve. -80% by next month. last CRL was efficacy and this resubmission brings no new data only re-arguing the same file. screenshot this"  
[X Link](https://x.com/anyuser/status/2002644936815219019)  2025-12-21T07:38Z [----] followers, 22.3K engagements


"1/ $ALDX will get cut in half next week. Watch"  
[X Link](https://x.com/anyuser/status/2021632835526721726)  2026-02-11T17:10Z [----] followers, [----] engagements


"9/ So if that preclusion-style notice hits next week I think $ALDX trades to about $2.5 from roughly $5.5 now. Thats around -55%. At the CRL I think closer to $1.5 about -70% plus from here"  
[X Link](https://x.com/anyuser/status/2021632842376036377)  2026-02-11T17:10Z [----] followers, [----] engagements


"10/ I bought Feb [--] $4 puts around $0.10. If it hits $2.5 intrinsic is $1.50. Thats about 15x before spreads. If timing slips fine. The real size is in March puts. I think this ends in a CRL"  
[X Link](https://x.com/anyuser/status/2021632843143643332)  2026-02-11T17:10Z [----] followers, [----] engagements


"$RGNX Turns out single arm n=13 wasn't good enough. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2020979990750183894)  2026-02-09T21:55Z [----] followers, 10.5K engagements


"1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2014710981406957634)  2026-01-23T14:45Z [----] followers, 33.1K engagements


"To the retail traders who are still long $HIMS You aren't "fighting the FDA." You are voluntarily funding a hedge fund manager's ski trip to Aspen. Selling unapproved drugs isn't a moat. It's a felony. Follow @BiotechAutist to stop donating your portfolio"  
[X Link](https://x.com/anyuser/status/2019924315026657692)  2026-02-07T00:00Z [----] followers, [----] engagements


"$RGNX @asamimes @BrianSkorney @LeerinkPartners @ClearStreetNews Youre analysts. Youre paid to be objective and impartial. Stop using delay as a euphemism when you KNOW retail hears delay and doesnt hear CRL. Youre leading people into a trap. You only get ONE PDUFA extension per review cycle. They already used it. There is no second extension. So around Feb [--] this delay framing is a CRL setup. If CRL is your base case say CRL. Retail deserves plain English not analyst word games"  
[X Link](https://x.com/anyuser/status/2016990829626134810)  2026-01-29T21:44Z [----] followers, [----] engagements


"$RGNX bulls: this is why I dont trade fairy tales. FDA clinical hold on REGENXBIO gene therapy programs including RGX-121 after a brain tumor case. When I say FDA risk is real this is the receipt. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2016499769225416850)  2026-01-28T13:13Z [----] followers, 10.3K engagements


"RT @stockholder30: Another great call by @BiotechAutist $RGNX crashing on this: "FDA halts $RGNX gene therapy trials after brain tumor fo"  
[X Link](https://x.com/anyuser/status/2016494246413382126)  2026-01-28T12:51Z [----] followers, [--] engagements


"Another great call by @BiotechAutist $RGNX crashing on this: "FDA halts $RGNX gene therapy trials after brain tumor found in patient" A must follow for all biotech investors 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan. 1/ 🧵 Im SHORT $RGNX If youre long because rare disease + surrogate = AA youre missing the ONLY thing that matters: The confirmatory plan"  
[X Link](https://x.com/anyuser/status/2016491997243027554)  2026-01-28T12:42Z [---] followers, [----] engagements


"11/ Want me to stop talking Show receipts: dosed patients (not recruiting) a prespecified SAP for [--] + [--] a real comparator plan and milestones that prove this isnt a decade-long punt"  
[X Link](https://x.com/anyuser/status/2014710990252736819)  2026-01-23T14:45Z [----] followers, [----] engagements


"12/ Until then Im betting the letter says what the math says. Save this thread. And follow @BiotechAutist to learn the rules before the rules learn you"  
[X Link](https://x.com/anyuser/status/2014710991116710057)  2026-01-23T14:45Z [----] followers, [----] engagements

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