(Reuters) -Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts’ advice when deciding on the company’s cell therapy for a heart condition associated with Duchenne muscular dystrophy.
The agency had earlier decided to 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’s stock had fallen nearly 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.
On Tuesday, the stock rose 11.6% to $8.57.
Capricor plans to meet FDA officials in person for a review meeting in mid-July, the company said, adding that the agency’s target date for the therapy remains August 31.
“We remain confident in the strength of our submission and continue to advance toward potential approval, with our next major step being the upcoming late-cycle review meeting,” CEO Linda Marbán said.
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)
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