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CAPR will get Accelerated approval soon

The FDA has granted Capricor's CAP-1002 RMAT and Orphan Drug Designation, and the Company plans to present this data to the FDA and seek additional guidance on the best path forward for DMD patients. Capricor is currently conducting a pivotal Phase 3 trial, HOPE-3, designed as a randomized, double-blind, placebo-controlled study with approximately 70 patients and enrollment criteria similar to HOPE-2. The Phase 3 study is currently open for enrollment (NCT05126758).