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Capricor Therapeutics Gets Another Type-B Meeting With FDA for Duchenne Muscular Dystrophy Investigational Drug
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Capricor Therapeutics Gets Another Type-B Meeting With FDA for Duchenne Muscular Dystrophy Investigational Drug
Apr 24, 2024 12:53 PM

03:21 PM EDT, 04/24/2024 (MT Newswires) -- Capricor Therapeutics ( CAPR ) said Wednesday the US Food and Drug Administration granted another Type-B meeting in Q2 to move ahead with the biologics license application for CAP-1002 for treating Duchenne muscular dystrophy.

The company said it will share safety and efficacy data from the open-label extension study with the FDA in the meeting.

The FDA agreed that comparability between drug product manufactured at facilities in Los Angeles and San Diego has been shown, allowing for the use of CAP-1002 drug product manufactured in San Diego facility upon potential product approval, the company said.

Capricor shares rose 5.6% in recent trading Wednesday.

Price: 5.09, Change: +0.27, Percent Change: +5.60

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