11.06.2024 16:33:44
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Capricor Therapeutics Announces Positive Type-B Meeting With FDA For CAP-1002
(RTTNews) - Capricor Therapeutics, Inc. (CAPR), Tuesday announced the successful completion of a Type-B meeting with the U.S. Food and Drug Administration regarding the submission of a Biologics License Application or BLA for CAP-1002 for the treatment of Duchenne muscular dystrophy.
During the meeting, the FDA agreed to conduct a pre-BLA meeting based on the clinical data of Hope-2, Hope-2 open label extension, and Hope-3, which would help the company submit an application, in the third quarter.
The biotechnology company stated that Duchenne muscular dystrophy is a devastating genetic disorder that causes chronic inflammation in the skeletal, heart, and respiratory muscles.
Further, Capricor noted that the World Health Organization has selected Deramiocel as the proposed International Nonproprietary Name or INN for CAP-1002.
Currently, Capricor's stock is moving up 0.92 percent, to $5.46 on the Nasdaq.
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