Capricor Therapeutics Shares Rise After Positive Type A Meeting With FDA

Dow Jones

Sep 25, 2025

By Chris Wack

Capricor Therapeutics shares were 10% higher, at $6.79, after the company reported positive news on the Biologics License Application for Deramiocel, its treatment for Duchenne muscular dystrophy.

The biotechnology company said the news follows a recent Type A meeting with the Food and Drug Administration after the receipt of a complete response letter in July.

The company said the goal of the Type A meeting was to establish a path toward potential approval of Deramiocel for the treatment of DMD. The meeting determined Capricor's clinical trial should serve as the "additional study" requested in the CRL, and that data can be submitted within the current BLA.

Capricor plans to submit trial data with its complete response to the CRL, with the goal of securing a label encompassing both cardiac and skeletal muscle function in DMD.

The company also said it has a strong financial position to support the advancement of Deramiocel through regulatory review and toward potential launch.

Capricor shares hit their 52-week low of $5.68 on Sept. 4, and are down 34% in the past 12 months.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 25, 2025 10:46 ET (14:46 GMT)

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