Capricor Shares Drop Sharply Following FDA AdCom Briefing Document Release
Capricor Therapeutics (CAPR) experienced a significant decline in early Monday trading, falling approximately 67%, following the release of an FDA briefing document ahead of its July 29 advisory committee meeting. The document raised concerns about the efficacy and safety profile of deramiocel, Capricor's investigational treatment for Duchenne muscular dystrophy. The FDA’s pre-AdCom analysis has cast doubt on whether the drug meets regulatory standards, which could impact its approval prospects. This development is a major setback for investors who had been closely watching the outcome of this critical review process.
Tickers: $CAPR
Topics: deramiocel Duchenne muscular dystrophy FDA advisory committee