Capricor Therapeutics stock plummets after FDA advisory meeting cancellation

In the United States, Capricor Therapeutics, Inc. experienced a significant decline in its stock price as a direct consequence of an FDA advisory committee meeting cancellation. This decision was made by Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research. The meeting was intended to evaluate Capricor's cell therapy for Duchenne muscular dystrophy (DMD) and has now cast uncertainty over the company's regulatory prospects. Earlier inspections by the FDA of Capricor’s San Diego manufacturing facility had shown no major deficiencies, resulting in the Biologics License Application remaining under priority review with a scheduled action date of August 31, 2025. However, a media report revealed that tensions within the FDA played a role in the cancellation, especially surrounding the leadership of Nicole Verdun, the former official overseeing cell and gene therapies. Reports indicated a disagreement within the FDA regarding the treatment's effectiveness, contributing to the tumultuous situation for Capricor's regulatory approvals. The tensions and leadership changes within the FDA are perceived as detrimental, as regulatory decisions on similar therapies have broad implications for the industry, particularly as many cell and gene therapy products await approval. The stock drop of nearly 30% reflects the market's reaction to the potential delays and uncertainty overshadowing Capricor's future developments, especially as there are five additional regulatory decisions concerning cell and gene therapy expected to be made in 2025. The situation highlights the intricate connection between regulatory evaluation processes and market confidence in biotech stocks, which are often sensitive to news of this kind. As the industry braces for future developments, the need for transparency and effective communication from regulatory bodies like the FDA remains critical. These developments signal a challenging environment for innovative therapies targeting rare diseases such as Duchenne muscular dystrophy and underscore the importance of stable oversight in achieving timely drug approvals.