Capricor Therapeutics Inc
CAPRCapricor Therapeutics Inc (CAPR) is a biotechnology company focused on developing cell-based therapeutics for rare and significant diseases, particularly in the areas of cardiology and other unmet medical needs. The company's primary focus is on regenerative medicine, utilizing its proprietary cell therapy platform to develop treatments aimed at repairing and regenerating damaged tissues.
Company News
Capricor Therapeutics announced positive Phase 3 HOPE-3 trial results for its cell therapy candidate deramiocel, causing its stock to surge dramatically. Martin Shkreli, who had previously predicted the trial's failure, criticized the data and claimed the company changed its primary endpoint.
Capricor Therapeutics met with the FDA to discuss regulatory approval for Deramiocel, its investigational cell therapy for Duchenne muscular dystrophy. The FDA provided clarity on the approval process and showed flexibility in reviewing trial data, causing the stock to surge.
Capricor Therapeutics received a Complete Response Letter from the FDA denying its Biologics License Application for deramiocel, causing a significant stock price drop and triggering a potential securities class action lawsuit.
A class action lawsuit has been filed against Capricor Therapeutics alleging false and misleading statements about the safety and efficacy of its Phase 2 HOPE-2 trial for deramiocel, with potential regulatory approval challenges.
Rosen Law Firm is pursuing a securities class action lawsuit against Therapeutics for allegedly providing misleading statements about its cell therapy drug deramiocel and its Phase 2 trial data, potentially causing investor damages.
