Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
SAN DIEGO, Nov. 20, 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 that the European Medicines Agency (EMA) has granted both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD). The Orphan Drug designation provides Capricor with several benefits that support the development of deramiocel in Europe, including market exclusivity for 10 years if approval is granted and substantially reduced regulatory fees. The ATMP designation provides substantial regulatory support to assist in the development of cell-based therapies. The additional support can potentially reduce time to market, streamline development, and open up access to critical resources, making it an invaluable tool for companies working on innovative therapies.
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News
- Deramiocel's Promise Brightens Capricor's Outlook, With Strings Attached [Seeking Alpha]Seeking Alpha
- Capricor Therapeutics to Present at Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics to Present at Upcoming Investor ConferencesGlobeNewswire
- Capricor wins key EU designations for the lead asset [Seeking Alpha]Seeking Alpha
- Parent Project Muscular Dystrophy Culminates 30th Anniversary with Celebratory "Investing in Every Future" Event [Yahoo! Finance]Yahoo! Finance
CAPR
Earnings
- 11/13/24 - Miss
CAPR
Sec Filings
- 12/16/24 - Form 4
- 12/4/24 - Form 4
- 11/14/24 - Form 10-Q
- CAPR's page on the SEC website