Capricor Therapeutics (NASDAQ:CAPR – Get Free Report) released its quarterly earnings results on Thursday. The biotechnology company reported ($0.70) EPS for the quarter, missing the consensus estimate of ($0.59) by ($0.11), Zacks reports.
Here are the key takeaways from Capricor Therapeutics’ conference call:
- The FDA advisory committee voted 3–9 against substantial evidence supporting deramiocel for DMD cardiomyopathy, and the FDA also issued one observation in a Bioresearch Monitoring Inspection.
- Capricor plans to amend its BLA with 24-month open-label data and additional analyses seeking an indication focused on upper-limb skeletal function, the HOPE-3 primary endpoint; the FDA has indicated it will review the amendment and extend the PDUFA date.
- The company disclosed that the reported left-ventricular-ejection-fraction result changed under the prespecified statistical model to a 1.8-point treatment difference with a P=0.09, while the primary upper-limb endpoint remained statistically significant and the cardiomyopathy subgroup result was unchanged.
- Second-quarter operating expenses rose to $42.9 million from $27.7 million a year earlier, producing a $40.7 million net loss; Capricor held $237.9 million in cash and marketable securities and is slowing commercial spending pending regulatory clarity.
- The company withdrew its preliminary-injunction motion against NS Pharma without prejudice and expects arbitration over the U.S. distribution agreement to begin this fall, while broader pipeline work remains on hold and expansion programs are being stage-gated by the U.S. regulatory pathway.
Capricor Therapeutics Trading Up 58.0%
NASDAQ CAPR opened at $6.65 on Friday. The business’s 50-day moving average price is $18.18 and its 200 day moving average price is $25.38. Capricor Therapeutics has a twelve month low of $2.96 and a twelve month high of $40.37. The company has a market capitalization of $385.10 million, a PE ratio of -2.71 and a beta of 0.54.
Analysts Set New Price Targets
View Our Latest Research Report on CAPR
Insider Activity at Capricor Therapeutics
In other news, CFO Anthony Bergmann sold 24,100 shares of the stock in a transaction dated Thursday, June 25th. The shares were sold at an average price of $30.38, for a total transaction of $732,158.00. Following the transaction, the chief financial officer directly owned 11,223 shares in the company, valued at $340,954.74. This represents a 68.23% decrease in their position. The sale was disclosed in a legal filing with the SEC, which is available at this link. Over the last three months, insiders have sold 25,000 shares of company stock worth $759,158. Corporate insiders own 9.20% of the company’s stock.
Hedge Funds 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 shares of Capricor Therapeutics during the 4th quarter worth $51,533,000. Tang Capital Management LLC purchased a new stake in Capricor Therapeutics during the fourth quarter valued at about $49,062,000. RA Capital Management L.P. purchased a new stake in Capricor Therapeutics during the fourth quarter valued at about $43,516,000. Geode Capital Management LLC increased its stake in Capricor Therapeutics by 5.8% during the fourth quarter. Geode Capital Management LLC now owns 1,017,332 shares of the biotechnology company’s stock worth $29,367,000 after acquiring an additional 55,766 shares during the last quarter. Finally, State Street Corp increased its stake in Capricor Therapeutics by 3.5% during the fourth quarter. State Street Corp now owns 829,521 shares of the biotechnology company’s stock worth $23,940,000 after acquiring an additional 28,177 shares during the last quarter. Hedge funds and other institutional investors own 21.68% of the company’s stock.
Trending Headlines about Capricor Therapeutics
Here are the key news stories impacting Capricor Therapeutics this week:
- Positive Sentiment: The FDA indicated it is willing to review an amendment to Capricor’s Biologics License Application for deramiocel. The company plans to submit 24-month extension data from the HOPE-3 Phase 3 trial, potentially giving the treatment a regulatory lifeline after an earlier advisory committee rejection. Capricor outlines BLA amendment plan as FDA signals willingness to review
- Positive Sentiment: HOPE-3 results were published in The Lancet, with the trial achieving its primary upper-limb-function endpoint at a statistically significant p-value of 0.029. The data could strengthen Capricor’s case in discussions with regulators. Capricor Therapeutics Reports Second Quarter 2026 Financial Results
- Positive Sentiment: Capricor reported approximately $238 million in cash, cash equivalents and marketable securities as of June 30, providing resources to advance deramiocel and support regulatory activities.
- Neutral Sentiment: A PDUFA decision date of August 22 is being monitored by investors, although the potential impact depends on the FDA’s review of the amended application and the strength of the submitted data.
- Negative Sentiment: Capricor reported a second-quarter loss of $0.70 per share, worse than the $0.59 consensus estimate, underscoring ongoing cash burn and the absence of established commercial revenue. Capricor second-quarter earnings report
- Negative Sentiment: Multiple law firms publicized a securities-fraud class action covering investors who purchased shares from December 17, 2025, through July 26, 2026. The allegations include misleading statements about deramiocel’s FDA approval prospects and deviations from HOPE-3’s prespecified protocol and statistical analysis plan. The lead-plaintiff deadline is September 28, 2026; the claims have not been proven in court. Capricor securities-fraud class action notice
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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