Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway

June 11, 2024

https://www.globenewswire.com/news-release/2024/06/11/2896916/0/en/Capricor-Therapeutics-Announces-Positive-Type-B-Meeting-with-FDA-for-CAP-1002-Program-for-Duchenne-Muscular-Dystrophy-with-an-Aim-to-Expedite-BLA-Pathway.html

–FDA Grants Pre-BLA Meeting Request and Rolling BLA Submission after Review of HOPE-2 and HOPE-2 OLE 3-Year Results–

SAN DIEGO, June 11, 2024 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of a Type-B meeting with the U.S. Food and Drug Administration (FDA) on next steps for the Biologics License Application (BLA) submission with its lead asset, CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). Additionally, Deramiocel has been selected as the proposed International Nonproprietary Name (INN) for CAP-1002 by the World Health Organization.

Read more at globenewswire.com

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