Capricor Therapeutics: FDA Feedback Confirms CAP-1002's Path Towards BLA

(RTTNews) - Capricor Therapeutics (CAPR) announced an update on the positive Type-B clinical meeting with the FDA on the design and execution of HOPE-3, Phase 3 trial with lead asset CAP-1002 in treating Duchenne muscular dystrophy. The company said the feedback on trial design and timeline confirmed CAP-1002's path towards a future Biologics License Application submission.

Linda Marbán, CEO, said: "Although product from our San Diego site would not be required to support registration of CAP-1002, we do plan to enroll a separate cohort with product manufactured from our San Diego site, with a view toward meeting potential increased commercial demand following initial registration."

The company remains on track to complete HOPE-3 enrollment and expects to report the outcome of an interim analysis in the fourth quarter of 2023. Capricor plans to submit a BLA for CAP-1002 in 2025.

Capricor and the FDA also discussed the potential for alternative approval pathways.

Shares of Capricor Therapeutics are down 22% in pre-market trade on Friday.

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