Capricor boosts manufacturing capacity as FDA decision on DMD cell therapy looms

Capricor Therapeutics, a biotech developing a cell therapy for Duchenne muscular dystrophy, is preparing for an FDA decision expected by late November.

The company’s third-quarter operating expenses rose sharply, with spending on manufacturing climbing to about $45 million, up from $26 million a year earlier.

Its San Diego facility is already operational, equipped to produce enough doses for roughly 250 patients annually, and a second-floor expansion is under way to raise capacity to between 2,000 and 2,500 patients per year.

The increased investment signals Capricor’s intent to launch the therapy quickly if it receives approval, highlighting the importance of the upcoming regulatory outcome for the firm.