TLDR
- CAPR stock surged more than 100% in premarket trading Friday after Capricor announced plans to submit an amended BLA for Deramiocel
- The FDA advisory panel voted 9-3 against recommending Deramiocel for DMD-associated cardiomyopathy last month
- Capricor now plans to pursue an upper limb skeletal muscle indication instead, supported by 24-month open-label extension data
- The FDA has confirmed it is willing to review the amendment and will extend the PDUFA action date upon receipt
- A securities fraud class action lawsuit has been filed against Capricor, with a lead plaintiff deadline of September 28, 2026
Capricor Therapeutics (CAPR) stock more than doubled in premarket trading Friday, climbing over 100%, after the company announced it plans to submit an amended Biologics License Application for its lead drug, Deramiocel.
Capricor Therapeutics, Inc., CAPR
The move comes after a rough stretch for the company. On July 27, 2026, CAPR stock fell 64.5%, dropping from $19.70 to $7.00 after the FDA released briefing documents raising concerns about changes to Capricor’s statistical analysis plan ahead of an advisory committee meeting.
Two days later, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 9-3 against recommending Deramiocel for cardiomyopathy in Duchenne muscular dystrophy. That sent the stock down another 36%, from $6.57 to $4.19.
The BLA is currently under FDA review with a target action date of August 22.
CEO Linda Marbán addressed the situation during the company’s Q2 2026 earnings call. She pointed out that cardiomyopathy was a secondary endpoint in the Phase 3 HOPE-3 study, not the primary one.
“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,” Marbán said.
New Indication in Focus
Capricor now plans to pursue approval for an upper limb skeletal muscle indication, which aligns with HOPE-3’s primary efficacy endpoint. The company will submit an amendment to the BLA backed by 24-month open-label extension data and additional analysis from its existing data package.
The FDA has confirmed it is willing to review the amendment and will extend the PDUFA action date once it is received.
Securities Fraud Lawsuit Filed
While the stock is bouncing, Capricor is also dealing with legal pressure. Securities law firm Bleichmar Fonti & Auld has filed a class action lawsuit against the company and certain senior executives.
The lawsuit alleges Capricor made false statements about Deramiocel and the integrity of the clinical data supporting its BLA. It also alleges the company failed to disclose that it adopted changes to the pre-specified statistical analysis plan without FDA agreement before resubmitting the BLA.
The case is filed in the U.S. District Court for the Southern District of California. Investors have until September 28, 2026 to apply to serve as lead plaintiff.
The current PDUFA target action date remains August 22, with the amended submission expected to push that date out further.
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