Capricor Therapeutics, Inc.
Case Overview
| Status: | Status: Investigating |
| Company Name: | Company Name: Capricor Therapeutics, Inc. |
| Ticker: | Ticker: CAPR |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
On July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting with Capricor regarding the Company’s lead product candidate, deramiocel, a cell therapy for a heart condition related to Duchenne muscular dystrophy. Among other things, the briefing documents revealed that agency staff concluded Capricor’s data did not provide “substantial evidence of effectiveness,” noting that approval generally requires at least two adequate and well-controlled studies while deramiocel’s application rested on a single pivotal trial. In a story covering the news, Stat News wrote that “[a]fter the study was completed, the FDA said, Capricor made a litany of changes to its statistical analysis plan, a crucial document outlining how a study will be measured. Revising that plan after a study is done raises concerns that a company may be looking to generate a positive outcome when there wasn’t one based on its original design.”
Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. The Company had also characterized its Biologics License Application as on track ahead of an August 2026 PDUFA date and pointed to positive long-term clinical data.
On this news, Capricor’s stock price fell $12.70 per share, or approximately 64.5%, to close at $7.00 per share on July 27, 2026.
Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. The Company had also characterized its Biologics License Application as on track ahead of an August 2026 PDUFA date and pointed to positive long-term clinical data.
On this news, Capricor’s stock price fell $12.70 per share, or approximately 64.5%, to close at $7.00 per share on July 27, 2026.