Capricor Says FDA Briefing Relies On Obsolete Analysis Plan Ahead Of Deramiocel Advisory Committee Meeting For Duchenne Muscular Dystrophy BLA
Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today provided an update ahead of the Company's upcoming FDA Advisory
Capricor is telling the FDA that the plan used to check their Duchenne muscle disease medicine is outdated and needs updating. This shows the company thinks the FDA's old way of looking at the medicine might not be fair, which could matter when the FDA makes its final decision.
Last session drawn · prints held ~15 minutes · licensed exchange data
Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
Disclosure: Educational and informational purposes only — not financial advice. We educate, not advise. Market data may be delayed up to 15 minutes unless marked real-time. Past performance is not indicative of future results.