Capricor wins key EU designations for the lead asset [Seeking Alpha]
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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US:NASDAQ Investor Relations:
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Source: Seeking Alpha
The EU drug regulator has issued orphan and ATMP designations for Capricor's ( NASDAQ: CAPR ) development work related to deramiocel in Duchenne muscular dystrophy, a muscle-wasting disorder affecting an estimated one in every 3,500 male births worldwide. Benefits of the EU's orphan drug designation include 10-year-long market exclusivity for the product and substantially lower regulatory fees. Companies with ATMP designations can receive EU regulatory support for their R&D work related to cell and gene therapies. A cell-based therapy, deramiocel is currently the subject of an ongoing rolling Biologics License Application (BLA) filed by the company in the U.S. targeting patients with DMD-cardiomyopathy. Capricor ( CAPR ) expects to complete the rolling submission this year. Recommended For You Comments More Trending News Recommended For You More Trending News
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News
- Parent Project Muscular Dystrophy Culminates 30th Anniversary with Celebratory "Investing in Every Future" Event [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines AgencyGlobeNewswire
- Capricor Therapeutics Third Quarter 2024 Earnings: Misses Expectations [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Inc (NASDAQ: CAPR) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $77.00 price target on the stock.MarketBeat
CAPR
Earnings
- 11/13/24 - Miss
CAPR
Sec Filings
- 11/14/24 - Form 10-Q
- 11/13/24 - Form 8-K
- 11/12/24 - Form SC
- CAPR's page on the SEC website