Capricor Therapeutics (NASDAQ:CAPR – Get Free Report) announced its quarterly earnings results on Tuesday. The biotechnology company reported ($0.59) earnings per share (EPS) 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 Trading Down 0.8%
Shares of Capricor Therapeutics stock traded down $0.24 during trading hours on Thursday, reaching $30.09. 382,577 shares of the company’s stock were exchanged, compared to its average volume of 1,279,687. The company has a 50 day moving average of $31.71 and a two-hundred day moving average of $24.03. The stock has a market cap of $1.74 billion, a P/E ratio of -12.97 and a beta of 0.48. Capricor Therapeutics has a fifty-two week low of $4.30 and a fifty-two week high of $40.37.
Analysts Set New Price Targets
Check Out Our Latest Analysis on CAPR
Insider Transactions at Capricor Therapeutics
In other news, Director Karimah Es Sabar sold 7,529 shares of the company’s stock in a transaction dated Thursday, April 2nd. The shares were sold at an average price of $32.00, for a total value of $240,928.00. Following the sale, the director directly owned 7,529 shares of the company’s stock, valued at approximately $240,928. This represents a 50.00% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CFO Anthony Bergmann sold 25,000 shares of the company’s stock in a transaction dated Friday, May 1st. The shares were sold at an average price of $31.70, for a total transaction of $792,500.00. Following the completion of the sale, the chief financial officer directly owned 8,223 shares in the company, valued at approximately $260,669.10. The trade was a 75.25% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last ninety days, insiders sold 172,529 shares of company stock worth $5,302,440. 9.20% of the stock is owned by insiders.
Institutional Inflows and Outflows
Several large investors have recently bought and sold shares of CAPR. Suvretta Capital Management LLC bought a new position in Capricor Therapeutics in the 4th quarter valued at about $51,533,000. Tang Capital Management LLC acquired a new position in shares of Capricor Therapeutics during the 4th quarter worth approximately $49,062,000. RA Capital Management L.P. acquired a new position in shares of Capricor Therapeutics during the 4th quarter worth approximately $43,516,000. Darwin Global Management Ltd. acquired a new position in shares of Capricor Therapeutics during the 4th quarter worth approximately $23,168,000. Finally, Balyasny Asset Management L.P. acquired a new position in shares of Capricor Therapeutics during the 4th quarter worth approximately $10,188,000. 21.68% of the stock is owned by institutional investors.
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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