Capricor Therapeutics (NASDAQ:CAPR – Get Free Report) released its quarterly earnings results on Thursday. The biotechnology company reported ($0.70) earnings per share for the quarter, missing analysts’ consensus estimates 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 Stock Up 0.5%
NASDAQ:CAPR traded up $0.02 during trading hours on Thursday, hitting $4.21. 13,102,623 shares of the stock were exchanged, compared to its average volume of 2,008,055. 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 $243.80 million, a P/E ratio of -1.81 and a beta of 0.54. The company’s 50 day moving average is $19.06 and its two-hundred day moving average is $25.64.
Wall Street Analysts Forecast Growth
Get Our Latest Stock Report on Capricor Therapeutics
Insider Buying and Selling
In other Capricor Therapeutics news, CFO Anthony Bergmann sold 24,100 shares of the business’s stock in a transaction dated Thursday, June 25th. The stock was sold at an average price of $30.38, for a total transaction of $732,158.00. Following the completion of the sale, the chief financial officer directly owned 11,223 shares of the company’s stock, valued at approximately $340,954.74. The trade was a 68.23% decrease in their position. The sale was disclosed in a document filed with the SEC, which can be accessed through the SEC website. Insiders sold 25,000 shares of company stock valued at $759,158 in the last three months. 9.20% of the stock is owned by company insiders.
Institutional Inflows and Outflows
Several hedge funds have recently modified their holdings of the business. Creek Drive Management Group LLC acquired a new stake in shares of Capricor Therapeutics during the 4th quarter worth approximately $1,039,000. Ikarian Capital LLC lifted its holdings in Capricor Therapeutics by 118.4% in the fourth quarter. Ikarian Capital LLC now owns 578,015 shares of the biotechnology company’s stock valued at $16,682,000 after buying an additional 313,373 shares during the period. Virtus Investment Advisers LLC grew its holdings in Capricor Therapeutics by 25.2% during the 4th quarter. Virtus Investment Advisers LLC now owns 10,224 shares of the biotechnology company’s stock worth $295,000 after acquiring an additional 2,061 shares during the period. Susquehanna Portfolio Strategies LLC bought a new stake in shares of Capricor Therapeutics during the 4th quarter valued at $384,000. Finally, Tang Capital Management LLC bought a new stake in shares of Capricor Therapeutics during the 4th quarter valued at $49,062,000. Institutional investors own 21.68% of the company’s stock.
Key Capricor Therapeutics News
Here are the key news stories impacting Capricor Therapeutics this week:
- Positive Sentiment: Capricor said the FDA is actively reviewing its Biologics License Application for deramiocel, a key regulatory catalyst for the company. The company also highlighted published HOPE-3 Phase 3 results showing the trial achieved its primary upper-limb-function endpoint with statistical significance (p=0.029). Capricor Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
- Positive Sentiment: Capricor reported approximately $238 million in cash, cash equivalents and marketable securities as of June 30, 2026, providing substantial funding as it seeks potential approval and commercialization of deramiocel.
- Neutral Sentiment: The company’s quarterly results and corporate update were scheduled for discussion on an afternoon conference call, giving investors an opportunity to obtain additional detail on the FDA review, clinical data and development plans.
- Negative Sentiment: Second-quarter adjusted results were a loss of $0.70 per share, wider than the consensus estimate of a $0.59 loss. The miss reinforces concerns about ongoing cash burn and the lack of near-term product revenue. Capricor Therapeutics Quarterly Earnings Press Release
- Negative Sentiment: Multiple law firms are promoting a securities class action covering investors who bought CAPR between December 17, 2025, and July 26, 2026. The lawsuit alleges Capricor made misleading statements about blinding and protocol procedures in the HOPE-3 trial, after FDA briefing materials and an adverse advisory committee vote triggered a major selloff. The legal claims are allegations, but the litigation adds reputational, financial and regulatory uncertainty; the lead-plaintiff deadline is September 28, 2026. CAPR Deadline Alert Securities Class Action
Capricor Therapeutics Company Profile
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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