Key Takeaways
- Shares of CAPR jumped over 100% during Friday’s premarket session following Capricor’s announcement of an amended Biologics License Application for Deramiocel
- An FDA advisory committee rejected Deramiocel for DMD-related cardiomyopathy by a 9-3 vote in late July
- The biotech company is now shifting focus to an upper limb skeletal muscle indication, backed by extended 24-month trial data
- FDA officials have indicated willingness to review the amended application and will postpone the PDUFA decision date accordingly
- Capricor faces a securities fraud class action lawsuit, with investors having until September 28, 2026 to seek lead plaintiff status
Shares of Capricor Therapeutics (CAPR) experienced explosive growth in Friday’s premarket session, soaring more than 100% following the company’s strategic announcement regarding an amended Biologics License Application for Deramiocel, its flagship therapeutic candidate.
Capricor Therapeutics, Inc., CAPR
This dramatic uptick follows a challenging period for the biotechnology firm. On July 27, 2026, shares of CAPR plummeted 64.5%, tumbling from $19.70 to $7.00 after the Food and Drug Administration published briefing materials expressing reservations about modifications Capricor made to its statistical analysis framework prior to a scheduled advisory committee review.
The situation deteriorated further on July 29 when the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee delivered a 9-3 vote against endorsing Deramiocel for treating cardiomyopathy associated with Duchenne muscular dystrophy. The negative vote triggered an additional 36% decline, with shares falling from $6.57 to $4.19.
The existing BLA remains under FDA evaluation, with a scheduled PDUFA action date of August 22.
Chief Executive Officer Linda MarbĆ”n provided context during Capricor’s second quarter 2026 earnings conference call. She emphasized that cardiomyopathy represented a secondary measure in the Phase 3 HOPE-3 clinical trial rather than the principal endpoint.
“The Advisory Committee was not asked to vote on whether they believe the data on the HOPE-3 primary efficacy endpoint could support approval of the product, nor whether the overall benefit-risk profile of Deramiocel was favorable,” MarbĆ”n said.
Strategic Pivot to Alternative Indication
Capricor has announced its intention to seek regulatory approval for an upper limb skeletal muscle indication, which corresponds directly to the primary efficacy measure evaluated in the HOPE-3 trial. The amended BLA submission will incorporate 24-month data from open-label extension studies along with supplementary analyses derived from the company’s comprehensive data portfolio.
Regulatory authorities have signaled their readiness to evaluate the amended application and have indicated they will adjust the PDUFA action date following receipt of the submission.
Legal Challenges Emerge
Despite the positive market reaction, Capricor confronts mounting legal challenges. Bleichmar Fonti & Auld, a securities litigation firm, has initiated a class action complaint against the company and specific members of its executive leadership team.
The complaint contends that Capricor disseminated misleading information regarding Deramiocel and the reliability of clinical evidence underpinning the BLA submission. Additionally, plaintiffs allege the company concealed the fact that it implemented modifications to the predetermined statistical analysis framework without securing FDA authorization prior to resubmitting the application.
The litigation has been initiated in the United States District Court for the Southern District of California. Affected shareholders have until September 28, 2026 to petition the court for appointment as lead plaintiff.
The existing PDUFA deadline remains set for August 22, though the forthcoming amended submission is anticipated to result in an extended review timeline.
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