Capricor, Priority Review and FDA

Capricor Therapeutics’ Retail Chatter Explodes On Stocktwits After FDA Grants Priority Review For DMD Therapy
Shares of Capricor Therapeutics (CAPR) closed Tuesday with modest gains and rose more than 3% in extended trading after the company announced a key regulatory milestone for its investigational therapy,
Capricor Therapeutics Shares Rise on FDA Priority Review
Capricor Therapeutics' shares rose after its biologics license application for deramiocel to treat a form of muscular dystrophy was given priority review by the Food and Drug Administration. Shares climbed 10% to $14.99 Tuesday morning. The stock has more than tripled over the past year.
Capricor Therapeutics stock rises on FDA priority review
In addition to the Priority Review, deramiocel has received Orphan Drug Designation from the FDA and EMA, as well as RMAT and ATMP Designations in the U.S. and Europe, respectively. Furthermore, Capricor could be eligible for a Priority Review Voucher if deramiocel is approved by September 30, 2026, due to its rare pediatric disease designation.
Capricor announces FDA acceptance, Priority Review for deramiocel BLA
Capricor Therapeutics (CAPR) announced the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking
Capricor Therapeutics' Cell Therapy for Muscular Dystrophy Patients to Get FDA Priority Review
The Food and Drug Administration has accepted Capricor Therapeutics' application seeking approval of its cell therapy deramiocel for muscular dystrophy patients and granted it a priority review. The FDA plans to take action on the application by Aug.
Capricor: Further Value Unlocked With Priority Review Of Deramiocel
Capricor Therapeutics, Inc.'s Deramiocel receives FDA Priority Review for DMD cardiomyopathy, with a decision by Aug. 2025. Click for my CAPR stock update.
Capricor Therapeutics options imply 7.5% move in share price post-earnings
Pre-earnings options volume in Capricor Therapeutics (CAPR) is normal with calls leading puts 19:7. Implied volatility suggests the market is
Capricor Therapeutics Cell Therapy Goes Under Priority FDA Review For Duchenne Associated-Heart Condition
On Tuesday, the FDA accepted for review Capricor Therapeutics Inc’s (NASDAQ:CAPR) Biologics License Application for ...
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Wojcicki’s controversial bid to reclaim 23andMe
23andMe CEO Anne Wojcicki is attempting to buy her company back for a mere $42 million. It’s a fraction of the company’s ...
Stock Traders Buy Large Volume of Capricor Therapeutics Call Options (NASDAQ:CAPR)
Capricor Therapeutics Inc (NASDAQ:CAPR – Get Free Report) saw unusually large options trading activity on Monday. Traders bought 4,400 call options on the stock. This is an increase of 37% compared to ...
Capricor Therapeutics: Heavily Derisked After BLA Submission And OLE Data
Capricor Therapeutics filed a BLA for deramiocel, showing promising results in slowing cardiac dysfunction in DMD ...
Analysts Conflicted on These Healthcare Names: Pliant Therapeutics (PLRX) and Capricor Therapeutics (CAPR)
Analysts have been eager to weigh in on the Healthcare sector with new ratings on Pliant Therapeutics (PLRX – Research Report) and Capricor ...
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Capricor Therapeutics (CAPR) to Release Earnings on Thursday
Analysts expect Capricor Therapeutics to post earnings of ($0.31) per share and revenue of $9.87 million for the quarter. Capricor Therapeutics Stock Down 11.1 % Shares of CAPR stock opened at $13 ...