CAPR

Capricor Therapeutics' stock price has experienced significant volatility over the past six months, largely influenced by developments related to its lead product candidate, Deramiocel, and its interactions with the FDA. In July 2026, the stock plummeted approximately 81% after an FDA briefing document challenged the statistical validity of Deramiocel's Phase 3 HOPE-3 trial results, leading to a 64% single-day plunge. An additional 36% decline occurred after an FDA Advisory Committee voted 9-to-3 against finding sufficient evidence to support Deramiocel's effectiveness for DMD-associated cardiomyopathy. The FDA's final PDUFA target action date for Deramiocel is August 22, 2026. On July 26, 2026, the company announced it had secured a lease for a new headquarters and expanded manufacturing facility, a move tied directly to the potential FDA approval of Deramiocel. More recently, on October 5, 2026, the stock declined by roughly 10% despite the announcement of positive 24-month crossover data from the HOPE-3 open-label extension study for Deramiocel, which showed a 76% reduction in upper limb decline, as analysts remain divided on the drug's FDA approval prospects. The stock saw a 10.50% increase on September 30, 2026, and a 4.52% increase on October 7, 2026, but experienced declines of 1.11% on October 8, 2026, and 2.43% on October 9, 2026. Over the past year, the stock has shown a +7.1% change in closing prices, but a -11.6% change over the past month.