Capricor's Duchenne cell therapy deramiocel faces FDA decision on 22 November

Capricor Therapeutics will learn on 22 November 2026 whether US regulators will approve deramiocel, its cell therapy for Duchenne muscular dystrophy. The company disclosed the date on 10 November, alongside its third-quarter results. The outcome is not known, and the filing says nothing about pricing or launch plans.

The deadline is later than originally planned because the FDA lengthened its review. According to Capricor, the agency treated an August submission as a substantial change to the application. That filing added two years of open-label follow-up data from the HOPE-3 study and proposed a narrower use of the product, centred on upper-limb function.

Capricor also said FDA inspectors visited in July as part of a review of clinical-trial conduct and data handling. The visit ended with a Form 483 listing one observation. The information available does not describe the observation or say how Capricor has answered it.

For the quarter, the company reported a net loss of $42.7m and roughly $198.5m in cash. It described the loss as wider than before, but the figures available include no prior-period comparison, so the size of the increase cannot be stated.