Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates to the BLA in February 2026 to support continued FDA review SAN DIEGO, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today provided a regulatory update regarding its Biologics License Application (BLA) for Deramiocel, the Company’s investigational first-in-class cell therapy for the treatment of Duchenne muscular dystrophy (DMD). As previously disclosed, the Company provided topline results from its Phase 3 HOPE-3 clinical study to the U.S. Food and Drug Administration (FDA) in late 2025. Following its review of these data, the FDA has formally requested the full HOPE-3 clinical study report (CSR) and supporting data to address the Complete Response Letter (CRL). The FDA did not request any additional clinical st
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- Capricor Therapeutics (NASDAQ:CAPR) had its "overweight" rating reaffirmed by analysts at Cantor Fitzgerald.MarketBeat
- Capricor Therapeutics (NASDAQ:CAPR) was downgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=CAPR&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall SMarketBeat
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- Here's Why This Biotechnology Skyrocketed by 439% in December [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics (NASDAQ:CAPR) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=CAPR&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StrMarketBeat
CAPR
Earnings
- 11/10/25 - In-Line
CAPR
Sec Filings
- 1/7/26 - Form 4
- 1/7/26 - Form 4
- 1/7/26 - Form 4
- CAPR's page on the SEC website