Capricor Therapeutics Remains Optimistic about Deramiocel FDA Approval

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.

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

The second-floor expansion is on track for full validation and FDA inspection in 2027.