Aug 24 (Reuters) – Capricor Therapeutics said on Monday that the U.S. Food and Drug Administration had extended the review of its experimental cell therapy for Duchenne muscular dystrophy by three months.
Shares of the company surged over 20% in early morning trading, as the update boosted market sentiment after a setback last month when an FDA advisory panel voted nine-to-three against the effectiveness data of the drug.
The health regulator set the deadline to November 22 to allow more time to review new clinical trial data submitted by the company.
Capricor’s therapy, called deramiocel, aims to treat Duchenne, a rare and progressive genetic disease that causes muscle wasting and mostly affects boys.
“With an additional year of follow-up from HOPE-3, we now have one of the most extensive clinical datasets evaluating upper limb function in Duchenne,” said Capricor CEO Linda Marbán.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shinjini Ganguli)
