This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has rejected what was ...
Capricor Therapeutics has publicly released its July response to the FDA's rejection of its Duchenne muscular dystrophy cell therapy deramiocel after the agency included deramiocel in a new batch of ...
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Capricor or Sarepta: Two DMD stocks enter a high-stakes week – which one has more upside?
Capricor is preparing a February submission to the FDA for its DMD cell therapy Deramiocel, following a formal request for the full Phase 3 Hope-3 clinical study report. ・Koyfin expects Sarepta to ...
Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy has come up short at the FDA, with the regulator rejecting the biotech’s application seeking regulatory approval for what the ...
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CAPR stock rallied nearly 30% so far this week — here’s the February FDA catalyst investors are betting on
The February filing centers on Deramiocel’s Phase 3 Hope-3 data, following the FDA's request for the full clinical study report without requiring new trials. ・The company's Phase 3 results showed ...
Capricor Therapeutics is raising issues with the U.S. Food and Drug Administration's new policy of publishing rejection letters sent to drugmakers. The FDA in June began publishing older letters, ...
Capricor plans to resubmit its BLA to the FDA, incorporating data from the ongoing Phase 3 HOPE-3 trial, indicating proactive steps toward potential approval for Deramiocel. The FDA's invitation for ...
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...
SAN DIEGO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (CAPR) (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, ...
Late-breaking presentation at MDA to feature Phase 3 HOPE-3 results supporting Deramiocel in Duchenne muscular dystrophyHOPE-3 clinical study ...
However, the FDA did not release the comprehensive preliminary response that Capricor submitted shortly after receipt of the CRL. This written response provided clarifications to the Agency’s feedback ...
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