Capricor forges ahead with FDA on Duchenne drug, despite political tumult

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

The Food and Drug Administration is nearly halfway through a review of Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy. Even with the tumult inside the agency, interactions between the company and the agency staff have been unaffected, according to the company’s chief executive.

“The information requests have been flowing on a regular basis and follow-up has been rapid and efficient,” CEO Linda Marbán told me during a phone call Friday. “The review continues to go really well.”

While there have been reports from other drugmakers about possible interruptions with FDA matters due to staff layoffs and the ouster of top officials, Capricor “hasn’t noticed any difference,” Marbán told me. 

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