Capricor says US FDA may not convene expert panel for co’s cell therapy

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By Mariam Sunny

(Reuters) -Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration has indicated that an advisory panel review may not be required for the company’s cell therapy for a heart condition associated with Duchenne muscular dystrophy.

The agency had earlier said it would hold a meeting of the advisory panel to discuss the company’s application for the therapy, deramiocel, to treat cardiomyopathy in patients with DMD.

Meanwhile, the Department of Health and Human Services said the FDA “is actively reevaluating whether to proceed with the advisory committee meeting” following withdrawal of its notice for the meeting.

It will communicate further updates when it decides, HHS, which oversees the FDA, told Reuters in an email.

Capricor plans to meet with FDA officials for a review meeting in mid-July, the company said, adding that the agency’s target date for a decision on the therapy remains August 31.

The meeting would be a valuable opportunity to make a case for approval, but the agency could ask for additional data in light of “ever-changing perceptions” with internal changes at the FDA, H.C. Wainwright analyst Joseph Pantginis said.

Shares of the firm rose nearly 19% to $9.14 on Tuesday.

Capricor’s stock has declined 36% in the previous two sessions after a STAT News report said that FDA’s chief regulator of cell and gene therapies, Nicole Verdun, was ousted over disagreements on the review of the therapy.

Cardiomyopathy, a condition which affects heart muscles, is the leading cause of death in patients with DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.

(Reporting by Mariam Sunny in Bengaluru; Editing by Leroy Leo)