CAPR - Capricor to meet with FDA in early Q3 to discuss CAP-1002 application

2023-06-07 12:56:27 ET

Capricor Therapeutics ( NASDAQ: CAPR ) said that it plans to meet with the US Food and Drug Administration in early Q3 to discuss its ongoing Phase 3 study and submission of a Biologics License Application for its lead product CAP-1002 for the treatment of Duchenne muscular dystrophy.

The biotech company said it plans to complete enrollment for the Phase 3 study during the second half of 2023 and release an interim analysis in Q4.

CAP-1001 has received Regenerative Medicine Advancement Therapy Designation and Orphan Drug Designation by the FDA. If the product is approved by the agency, Capricor would be eligible to receive a Priority Review voucher based on CAP-1002's designation as a rare pediatric disease.

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