Capricor Therapeutics, Inc. (CAPR) announced on Tuesday the successful conclusion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) concerning the submission of a Biologics License Application (BLA) for CAP-1002, aimed at treating Duchenne muscular dystrophy.
In the meeting, the FDA agreed to hold a pre-BLA meeting, contingent on the clinical data from Hope-2, the Hope-2 open-label extension, and Hope-3. This step will assist the company in preparing its BLA submission, expected in the third quarter.
The company highlighted that Duchenne muscular dystrophy is a severe genetic disorder characterized by chronic inflammation affecting the skeletal, cardiac, and respiratory muscles.
Additionally, Capricor announced that the World Health Organization has endorsed Deramiocel as the proposed International Nonproprietary Name (INN) for CAP-1002.
At present, Capricor's stock is experiencing an increase of 0.92%, trading at $5.46 on the Nasdaq.
