Capricor Therapeutics Gets Type-B Meeting With FDA for CAP-1002
By Chris Wack
Capricor Therapeutics said Wednesday that it has an upcoming
Type-B clinical meeting with the U.S. Food and Drug Administration
planned for early in the third quarter.
During the planned meeting with the FDA, Capricor said it will
outline its proposed path towards submission of a potential
Biologics License Application and further discuss its ongoing
clinical trial of CAP-1002 with the agency.
The company plans to use its CAP-1002 for the treatment of
Duchenne muscular dystrophy
The regulatory pathway for CAP-1002 is supported by a
Regenerative Medicine Advanced Therapy Designation, as well as a
Orphan Drug Designation.
If Capricor receives market approval for CAP-1002 by the FDA, it
would be eligible to receive a Priority Review Voucher based on its
designation as a rare pediatric disease.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
June 07, 2023 09:40 ET (13:40 GMT)
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