FDA, Capricor and Cell Therapy

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 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 deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.
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. 31, Capricor said Tuesday.
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 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 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: 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 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
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 ...
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 ...
Is Capricor Therapeutics, Inc. (CAPR) the Best Small-Cap Growth Stock to Buy Now?
We recently published a list of 10 Best Small-Cap Growth Stocks to Buy Now. In this article, we are going to take a look at ...
Are Small-Cap Stocks Poised for Growth?
We recently published a list of 10 Best Small-Cap Growth Stocks to Buy Now. In this article, we are going to take a look at ...