Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
--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. “The last year has been transformative for Capricor as we have moved rapidly towards potential approval for CAP-1002 for the treatment of DMD,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “The most recent meeting had several very imp
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News
- CORRECTION: Capricor TherapeuticsGlobeNewswire
- Capricor Therapeutics Announces for the Treatment of Duchenne Muscular DystrophyGlobeNewswire
- Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway [Yahoo! Finance]Yahoo! Finance
- Capricor (CAPR) Advances in DMD Therapy With Positive Study Data [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Announces Positive 3-Year Efficacy Results from HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy [Yahoo! Finance]Yahoo! Finance
CAPR
Earnings
- 5/13/24 - Miss
CAPR
Sec Filings
- 6/14/24 - Form S-3
- 5/15/24 - Form 8-K
- 5/15/24 - Form 8-K
- CAPR's page on the SEC website