Capricor says Deramiocel BLA talks continue with FDA

Capricor Therapeutics Inc. (NASDAQ: CAPR ) stock is trading higher on Friday after the gene therapy company released second-quarter earnings on Thursday after market close.

The company is actively engaged with the FDA regarding the Biologics License Application (BLA) for Deramiocel.

A recent Bioresearch Monitoring (BIMO) inspection resulted in a Form 483 with one observation, which Capricor has addressed and is awaiting feedback.

Commercial Readiness and Manufacturing Progress Capricor’s GMP manufacturing facility in San Diego is operational and ready to support an initial commercial launch, contingent on FDA approval.

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However, the company is advancing commercial readiness at a measured pace, awaiting further regulatory clarity.

NS Pharma Dispute and Long-Term Data Capricor said it has withdrawn its motion for a preliminary injunction against NS Pharma, opting to resolve the contractual dispute in arbitration following the FDA’s decision.

The company maintains its position that the pricing structure in the U.S.

Distribution Agreement is flawed and would hinder patient access, seeking rescission.

Regarding Deramiocel’s long-term safety and efficacy, Capricor has administered approximately 1,300 intravenous infusions to over 200 Duchenne Muscular Dystrophy (DMD) patients across three clinical trials.

The safety profile remains consistent and well-characterized, with some patients receiving continuous infusions for over five years.

Financial Outlook and Pipeline Updates Capricor reported a cash position of approximately $237.9 million as of June 30, 2026.

The company believes this is sufficient to fund operations for at least the next twelve months.

Further guidance on the longer-term financial outlook will be provided following regulatory clarity.

Capricor has initiated regulatory engagement in Europe and Japan for Deramiocel.

While expanding into younger DMD patients and Becker muscular dystrophy remains a priority, these trial initiations are contingent on the U.S. regulatory pathway.

Programs not directly related to Deramiocel, including the exosome-based platform, are temporarily on hold pending further regulatory clarity CAPR Stock Price Activity: Capricor Therapeutics shares were up 85.04% at $7.79 during premarket trading Friday, according to Pro data.

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