FDA Extends Review of Capricor Duchenne Drug
The FDA extended the review period for Capricor Therapeutics experimental Duchenne muscular dystrophy therapy by three months to November. The delay follows the submission of new data supporting a refined indication focused on upper limb function.
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Capricor Therapeutics received a three-month FDA review extension on Monday for its experimental cell therapy, pushing the decision deadline to November 22. The delay follows new data submissions targeting upper limb function in Duchenne muscular dystrophy patients. Investors reacted positively, sending shares up 15% to $7.25.
