Capricor Therapeutics Stock More Than Doubles After FDA Agrees to Review New Duchenne Drug Data and Lancet Publication

Capricor Therapeutics shares surged more than 100% on August 14, 2026, after the company announced the FDA is willing to review new data on deramiocel, its experimental treatment for Duchenne muscular dystrophy with cardiomyopathy. The company plans to amend its Biologics License Application with 24-month follow-up data from the HOPE-3 extension study, which was published in The Lancet and whose primary endpoint is described as potentially statistically and clinically significant. The stock had already jumped roughly 67% in after-hours trading on August 13 following the Q2 2026 earnings release.

Cantor Fitzgerald upgraded CAPR to Overweight from Neutral and set a price target of $28 on the news. The developments come after a prior FDA Advisory Committee rejection and reported protocol issues, making the FDA's willingness to accept a new submission a meaningful reversal. At the same time, multiple securities law firms, including Kaplan Fox, Rosen Law Firm, and Kahn Swick and Foti, have filed or are pursuing class action lawsuits against Capricor on behalf of investors who purchased shares between December 17, 2025 and July 26, 2026, with a lead plaintiff deadline of September 28, 2026.