Capricor Therapeutics Eyes FDA Approval Path for Duchenne Cell Therapy [Yahoo! Finance]
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: Yahoo! Finance
Capricor Therapeutics says it is in active discussions with the FDA to support approval of deramiocel for Duchenne muscular dystrophy, with the agency accepting HOPE-3 data for review and the company targeting a PDUFA date of Aug. 22, 2026 The company reported positive HOPE-3 results , saying the trial met its primary endpoint (Performance of the Upper Limb 2.0) and a key secondary endpoint tied to ejection fraction , which Capricor believes strengthens the case for both skeletal and cardiac benefits. Capricor plans to launch deramiocel independently after disputes with NS Pharma/Nippon Shinyaku, while also building commercial manufacturing and preparing pricing, reimbursement and market-access infrastructure ahead of a possible U.S. launch. Capricor Therapeutics Is Up Over 100%, Could Rise Even Higher Capricor Therapeutics (NASDAQ:CAPR) executives said the company is in active discussions with the U.S. Food and Drug Administration as it works toward a potential approval deci
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News
- Capricor Therapeutics (CAPR) was upgraded by LADENBURG THALM/SH SH to "strong-buy".MarketBeat
- Capricor's Positive 5-Year Data For DMD Treatment Comes With A Regulatory Catch – CAPR Stock Slides 11% [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular DystrophyGlobeNewswire
- Capricor to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Annual ConferenceGlobeNewswire
CAPR
Earnings
- 5/12/26 - Miss
CAPR
Analyst Actions
- 5/13/26 - HC Wainwright
CAPR
Sec Filings
- 6/29/26 - Form 4
- 6/29/26 - Form 4
- 6/26/26 - Form 8-K
- CAPR's page on the SEC website