By Siddhi Mahatole (Reuters) -Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of outside experts before deciding on the company’s cell therapy for a heart condition related to Duchenne muscular dystrophy (DMD). Shares of the drug developer fell nearly 15% to $10.11 in morning trade. The […]
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US FDA to convene expert panel for Capricor Therapeutics’ DMD cell therapy
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By Siddhi Mahatole
(Reuters) -Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of outside experts before deciding on the company’s cell therapy for a heart condition related to Duchenne muscular dystrophy (DMD).
Shares of the drug developer fell nearly 15% to $10.11 in morning trade.
The company is seeking full approval for its experimental cell therapy, deramiocel, as a potential treatment for patients diagnosed with Duchenne muscular dystrophy cardiomyopathy.
“We believe today’s share weakness is unwarranted,” H.C. Wainwright analyst Joseph Pantginis said, adding the opportunity to present at the meeting is “likely to strengthen the therapy’s petition”.
The heart muscle disease is a leading cause of death among patients with DMD, a condition characterized by progressive skeletal and heart muscle weakness.
The FDA is set to decide on the therapy by August 31, although the official date for the advisory panel meeting is yet to be set.
The mass firings at the FDA under Health and Human Services Secretary Robert F. Kennedy Jr. have sparked concerns about potential delays in the drug review process.
However, the FDA Chief Martin Makary said last week there were no plans for major reorganization at the agency and that it will meet its targets for completing reviews of new drugs despite the layoffs.
In March, the company said that the FDA had not indicated whether an advisory committee would be necessary but said that it had been actively preparing for one.
(Reporting by Siddhi Mahatole in Bengaluru)