Capricor Therapeutics Announces Upcoming Type-B Meeting with the FDA to Discuss Commercial Manufacturing Planning with an Aim to Expedite BLA Pathway for CAP-1002 in Duchenne Muscular Dyst...
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- – Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March. In the upcoming meeting with the FDA, the Company intends to discuss its proposed chemistry, manufacturing and controls (CMC) plans for commercial launch, if approved which may enable opportunities to expedite the pathway to a Biologics License Application (BLA) submission. The Company has previously been granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designations for the use of CAP-1002 in Duchenne muscular dystrophy (DMD) and these designations enable sponsors to work closely with the FDA and receive its guidance on potential expedited pathways for approval. “At this time, with our pivotal P
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News
- Capricor Therapeutics to Present at Upcoming Scientific and Medical ConferencesGlobeNewswire
- Capricor Therapeutics to Present First Quarter 2024 Financial Results and Recent Corporate Update on May 13GlobeNewswire
- Capricor Therapeutics Inc (NASDAQ: CAPR) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $40.00 price target on the stock.MarketBeat
- Here's Why We're Not Too Worried About Capricor Therapeutics' (NASDAQ:CAPR) Cash Burn Situation [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy [Yahoo! Finance]Yahoo! Finance
CAPR
Earnings
- 2/29/24 - Beat
CAPR
Sec Filings
- 4/29/24 - Form 8-K
- 4/25/24 - Form 4
- 4/24/24 - Form 4
- CAPR's page on the SEC website