[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  Bhavneesh Sharma MBBS, MD, MBA (Finance) [@bs2537](/creator/twitter/bs2537) on x 7863 followers Created: 2025-07-22 17:16:39 UTC *Bought Capricor Therapeutics (NASDAQ: CAPR), contrarian investment in biotech/pharma.* FDA’s recent CRL for deramiocel (cardiosphere derived stem cells) flagged “insufficient efficacy” but invited a Type-A meeting & re-file once HOPE-3 data land; CMC issues deemed minor and already addressed. Upcoming Phase X HOPE-3 trial design (n = 58, PUL-2.0) mirrors HOPE-2 closely (data in September); Dec-23 DSMB cleared continuation and triggered a $XX M Nippon Shinyaku milestone. Phase X HOPE-2 trial showed significant improvement in upper limb function and improvement in left heart function. The therapy targets all mutations in DMD and is likely to be used in addition to other therapies like gene therapy. Focus on cardiomyopathy in DMD, a major cause of mortality and morbidity, but also improved upper limb skeletal muscle function. Using HOPE-2 effect (Δ XXX pts, SD ≈ 2.5), Monte-Carlo simulation projects an 85–90 % shot at p < 0.05, still XX % in a conservative case. Both Los Angeles & new San-Diego plants passed FDA pre-licensure; management says remaining CMC questions are housekeeping. Capricor holds ~ $XXX M cash, funding operations into 2027, so no raise needed before Q3-25 resubmission. Rare-Pediatric-Disease tag means a lucrative Priority Review Voucher upon approval, extra $XXX M+ optionality. Bottom line: high-powered stats, clean manufacturing, and strong cash make FDA acceptance of the revised BLA likely, turning the CRL dip into a compelling contrarian opportunity. Not an investment advice. Please do your own research before investing. Long CAPR stock. #biotech #investing #DMD #stocks #pharma  XXXXX engagements  **Related Topics** [investment](/topic/investment) [nasdaq](/topic/nasdaq) [finance](/topic/finance) [sharma](/topic/sharma) [Post Link](https://x.com/bs2537/status/1947707375147741463)
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Bhavneesh Sharma MBBS, MD, MBA (Finance) @bs2537 on x 7863 followers
Created: 2025-07-22 17:16:39 UTC
Bought Capricor Therapeutics (NASDAQ: CAPR), contrarian investment in biotech/pharma.
FDA’s recent CRL for deramiocel (cardiosphere derived stem cells) flagged “insufficient efficacy” but invited a Type-A meeting & re-file once HOPE-3 data land; CMC issues deemed minor and already addressed.
Upcoming Phase X HOPE-3 trial design (n = 58, PUL-2.0) mirrors HOPE-2 closely (data in September); Dec-23 DSMB cleared continuation and triggered a $XX M Nippon Shinyaku milestone. Phase X HOPE-2 trial showed significant improvement in upper limb function and improvement in left heart function. The therapy targets all mutations in DMD and is likely to be used in addition to other therapies like gene therapy. Focus on cardiomyopathy in DMD, a major cause of mortality and morbidity, but also improved upper limb skeletal muscle function. Using HOPE-2 effect (Δ XXX pts, SD ≈ 2.5), Monte-Carlo simulation projects an 85–90 % shot at p < 0.05, still XX % in a conservative case.
Both Los Angeles & new San-Diego plants passed FDA pre-licensure; management says remaining CMC questions are housekeeping.
Capricor holds ~ $XXX M cash, funding operations into 2027, so no raise needed before Q3-25 resubmission.
Rare-Pediatric-Disease tag means a lucrative Priority Review Voucher upon approval, extra $XXX M+ optionality.
Bottom line: high-powered stats, clean manufacturing, and strong cash make FDA acceptance of the revised BLA likely, turning the CRL dip into a compelling contrarian opportunity.
Not an investment advice. Please do your own research before investing. Long CAPR stock. #biotech #investing #DMD #stocks #pharma
XXXXX engagements
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