Capricor Therapeutics (NASDAQ:CAPR – Get Free Report) issued its quarterly earnings data on Thursday. The biotechnology company reported ($0.70) earnings per share (EPS) 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 Performance
NASDAQ CAPR traded up $0.02 on Thursday, hitting $4.21. 13,102,623 shares of the stock traded hands, compared to its average volume of 2,008,055. The business’s fifty day moving average is $19.06 and its two-hundred day moving average is $25.64. Capricor Therapeutics has a 12 month low of $2.96 and a 12 month high of $40.37. The firm has a market capitalization of $243.80 million, a price-to-earnings ratio of -1.81 and a beta of 0.54.
Insider Activity
Hedge Funds Weigh In On Capricor Therapeutics
Several large investors have recently modified their holdings of the business. Russell Investments Group Ltd. boosted its holdings in Capricor Therapeutics by 122.2% in the 3rd quarter. Russell Investments Group Ltd. now owns 5,066 shares of the biotechnology company’s stock worth $37,000 after buying an additional 2,786 shares during the period. Tower Research Capital LLC TRC lifted its position in shares of Capricor Therapeutics by 280.8% during the second quarter. Tower Research Capital LLC TRC now owns 6,748 shares of the biotechnology company’s stock worth $67,000 after acquiring an additional 4,976 shares in the last quarter. Regal Investment Advisors LLC bought a new position in shares of Capricor Therapeutics in the third quarter worth $92,000. Envestnet Asset Management Inc. purchased a new position in shares of Capricor Therapeutics in the third quarter valued at $99,000. Finally, Brevan Howard Capital Management LP bought a new stake in shares of Capricor Therapeutics during the 3rd quarter valued at $123,000. Hedge funds and other institutional investors own 21.68% of the company’s stock.
Analysts Set New Price Targets
Several research firms have recently issued reports on CAPR. Oppenheimer reaffirmed a “market perform” rating on shares of Capricor Therapeutics in a report on Monday, July 27th. LADENBURG THALM/SH SH cut Capricor Therapeutics from a “buy” rating to a “neutral” rating in a research report on Thursday, July 30th. Alliance Global Partners lowered Capricor Therapeutics from a “buy” rating to a “neutral” rating and set a $7.00 target price for the company. in a research report on Tuesday, July 28th. JonesTrading cut Capricor Therapeutics from a “buy” rating to a “hold” rating in a research note on Friday, July 31st. Finally, Piper Sandler downgraded shares of Capricor Therapeutics from an “overweight” rating to a “neutral” rating and set a $2.00 price target on the stock. in a report on Thursday, July 30th. Ten research analysts have rated the stock with a Hold rating and one has assigned a Sell rating to the stock. According to data from MarketBeat, the stock has an average rating of “Reduce” and a consensus target price of $29.15.
Check Out Our Latest Stock Report on Capricor Therapeutics
Key Stories Impacting Capricor Therapeutics
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 potential treatment for Duchenne muscular dystrophy. The company also reported that HOPE-3 Phase 3 results were published in The Lancet, with the trial achieving its primary upper-limb function endpoint at 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 funding for regulatory activities and development programs.
- Neutral Sentiment: The company will discuss its second-quarter results and corporate update on a conference call, giving investors additional details on the FDA review and development plans. Capricor Earnings Conference Call
- Negative Sentiment: Capricor posted a quarterly loss of $0.70 per share, worse than the $0.59 consensus estimate. The earnings miss reinforces concerns about ongoing cash burn while the company remains pre-revenue.
- Negative Sentiment: Regulatory setbacks remain the principal concern. FDA briefing documents and an adverse advisory committee vote reportedly raised questions about deramiocel’s clinical data, including alleged deviations from prespecified blinding and statistical-analysis procedures. These developments contributed to a steep decline in CAPR shares from earlier levels and reduced confidence in near-term approval.
- Negative Sentiment: Several law firms publicized a securities class action alleging that Capricor and certain executives made misleading statements about the HOPE-3 trial and related FDA issues. The repeated notices increase reputational and potential legal-liability risks, although the allegations have not been proven. Investors generally have until September 28, 2026, to seek lead-plaintiff status. CAPR Securities Class Action Deadline Alert
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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