Capricor Therapeutics (NASDAQ:CAPR – Get Free Report) issued its quarterly earnings data on Tuesday. The biotechnology company reported ($0.59) earnings per share for the quarter, missing the consensus estimate of ($0.55) by ($0.04), FiscalAI reports.
Here are the key takeaways from Capricor Therapeutics’ conference call:
- Capricor said the deramiocel BLA remains under active FDA review with a PDUFA target date of August 22, 2026, and management expects labeling discussions in the near term.
- Management highlighted strong HOPE-3 results, including achievement of the primary PUL v2.0 endpoint, significant secondary endpoints, and encouraging cardiac data that they believe support deramiocel for DMD-associated cardiomyopathy.
- The company emphasized a favorable safety profile, citing more than 800 IV infusions across studies and up to five years of open-label extension data in some patients.
- Capricor announced it has filed suit against NS Pharma and Nippon Shinyaku seeking rescission of the distribution agreement and a preliminary injunction, arguing the current pricing structure would make broad reimbursement and patient access economically unworkable.
- The company said it is building commercial readiness and manufacturing capacity, with its San Diego facility already through FDA pre-license inspection and positioned for an initial launch, while also hiring key commercial leaders and preparing for possible self-distribution.
Capricor Therapeutics Stock Performance
NASDAQ:CAPR traded down $0.38 during mid-day trading on Tuesday, reaching $31.52. 1,055,184 shares of the company’s stock were exchanged, compared to its average volume of 1,285,195. Capricor Therapeutics has a one year low of $4.30 and a one year high of $40.37. The firm has a market capitalization of $1.82 billion, a PE ratio of -13.95 and a beta of 0.48. The business’s fifty day simple moving average is $31.57 and its two-hundred day simple moving average is $23.69.
Wall Street Analysts Forecast Growth
Check Out Our Latest Stock Analysis on Capricor Therapeutics
Insider Transactions at Capricor Therapeutics
In other Capricor Therapeutics news, CFO Anthony Bergmann sold 25,000 shares of the stock in a transaction dated Tuesday, March 31st. The shares were sold at an average price of $30.13, for a total transaction of $753,250.00. Following the sale, the chief financial officer directly owned 8,223 shares in the company, valued at $247,758.99. This represents a 75.25% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which is available at the SEC website. Also, Director Karimah Es Sabar sold 61,265 shares of the stock in a transaction dated Tuesday, March 31st. The stock was sold at an average price of $30.17, for a total transaction of $1,848,365.05. The disclosure for this sale is available in the SEC filing. Over the last ninety days, insiders have sold 172,529 shares of company stock worth $5,302,440. 9.20% of the stock is owned by insiders.
Institutional Investors Weigh In On Capricor Therapeutics
A number of large investors have recently bought and sold shares of CAPR. Suvretta Capital Management LLC acquired a new stake in Capricor Therapeutics during the fourth quarter worth about $51,533,000. Tang Capital Management LLC acquired a new stake in Capricor Therapeutics during the fourth quarter worth about $49,062,000. RA Capital Management L.P. acquired a new stake in Capricor Therapeutics during the fourth quarter worth about $43,516,000. Darwin Global Management Ltd. acquired a new stake in shares of Capricor Therapeutics in the 4th quarter valued at approximately $23,168,000. Finally, Balyasny Asset Management L.P. acquired a new stake in shares of Capricor Therapeutics in the 4th quarter valued at approximately $10,188,000. 21.68% of the stock is currently owned by institutional investors and hedge funds.
About Capricor Therapeutics
Capricor Therapeutics, Inc is a clinical-stage biotechnology company focused on the development of cell and exosome-based therapeutics for cardiovascular and rare diseases. Headquartered in Beverly Hills, California, the company leverages proprietary cardiosphere-derived cell (CDC) technology to address conditions characterized by inflammation, fibrosis, and tissue degeneration. Since its founding, Capricor has advanced its lead candidate through multiple clinical trials and has built a pipeline that spans both cell therapy and extracellular vesicle (exosome) platforms.
The company’s leading product candidate, CAP-1002, comprises allogeneic CDCs and is being evaluated in indications such as Duchenne muscular dystrophy (DMD) and COVID-19-related heart injury.
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