Dec 3 (Reuters) – Capricor Therapeutics said on Wednesday its cell therapy for a heart condition related to a rare muscular disorder met the main goal of a late-stage study, months after U.S. regulators rejected its initial approval bid.
The therapy, called deramiocel, slowed the progression of muscle weakness and helped preserve heart function in patients with Duchenne muscular dystrophy, a rare genetic disorder that causes muscle degeneration and is often fatal in early adulthood.
Earlier this year, the U.S. Food and Drug Administration declined to approve deramiocel, saying the treatment did not meet efficacy requirements and asked for additional data. Capricor said it plans to use the new results to respond to the agency’s so-called “complete response letter.”
Shares of the company were halted in premarket trading.
(Reporting by Mariam Sunny and Kamal CHoudhury in Bengaluru; Editing by Shinjini Ganguli and Leroy Leo)
Brought to you by www.srnnews.com
