Capricor Therapeutics (NASDAQ:CAPR – Get Free Report) posted its quarterly earnings results on Thursday. The biotechnology company reported ($0.70) 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 Up 0.5%
CAPR opened at $4.21 on Friday. The stock has a market capitalization of $243.81 million, a price-to-earnings ratio of -1.81 and a beta of 0.54. The firm has a 50 day moving average price of $18.58 and a 200-day moving average price of $25.51. Capricor Therapeutics has a twelve month low of $2.96 and a twelve month high of $40.37.
Insider Activity at Capricor Therapeutics
Institutional Investors Weigh In On Capricor Therapeutics
Several hedge funds and other institutional investors have recently added to or reduced their stakes in CAPR. State of Wyoming lifted its holdings in Capricor Therapeutics by 76.0% during the fourth quarter. State of Wyoming now owns 4,429 shares of the biotechnology company’s stock valued at $128,000 after purchasing an additional 1,913 shares in the last quarter. Royal Bank of Canada increased its stake in shares of Capricor Therapeutics by 12.4% in the fourth quarter. Royal Bank of Canada now owns 5,040 shares of the biotechnology company’s stock worth $146,000 after purchasing an additional 557 shares in the last quarter. Russell Investments Group Ltd. raised its position in shares of Capricor Therapeutics by 122.2% during the 3rd quarter. Russell Investments Group Ltd. now owns 5,066 shares of the biotechnology company’s stock valued at $37,000 after purchasing an additional 2,786 shares during the period. Tower Research Capital LLC TRC raised its position in shares of Capricor Therapeutics by 280.8% during the 2nd quarter. Tower Research Capital LLC TRC now owns 6,748 shares of the biotechnology company’s stock valued at $67,000 after purchasing an additional 4,976 shares during the period. Finally, Orion Porfolio Solutions LLC purchased a new position in shares of Capricor Therapeutics during the 4th quarter valued at $239,000. 21.68% of the stock is owned by hedge funds and other institutional investors.
Key Headlines Impacting Capricor Therapeutics
Here are the key news stories impacting Capricor Therapeutics this week:
- Positive Sentiment: Capricor said the Biologics License Application for deramiocel remains under active FDA review. The company also highlighted publication of its HOPE-3 Phase 3 results in The Lancet, with the trial achieving its primary upper-limb function endpoint at p=0.029. Capricor reported approximately $238 million in cash, cash equivalents and marketable securities as of June 30, providing substantial funding for regulatory and commercial activities. Capricor Second Quarter 2026 Results
- Neutral Sentiment: The company’s Q2 2026 earnings call and prepared remarks provided investors with additional management commentary on the deramiocel regulatory process and corporate outlook. However, the supplied reports do not identify a new catalyst beyond the previously announced clinical and regulatory updates. Capricor Q2 2026 Earnings Call Transcript
- Negative Sentiment: Capricor reported a quarterly loss of $0.70 per share, missing the analyst consensus estimate of a $0.59 loss. The company is expected to remain unprofitable, with analysts forecasting a full-year loss of approximately $1.62 per share. Capricor Quarterly Earnings Report
- Negative Sentiment: Multiple law firms publicized a securities-fraud class action and a September 28, 2026 lead-plaintiff deadline. The allegations center on claims that Capricor failed to follow specified blinding and protocol procedures in the HOPE-3 trial and that FDA materials identified deviations from the statistical analysis plan. The allegations have not been proven, but the litigation adds reputational, legal and regulatory uncertainty. Capricor Securities Class Action Notice
Wall Street Analyst Weigh In
Several equities analysts recently issued reports on CAPR shares. Oppenheimer reaffirmed a “market perform” rating on shares of Capricor Therapeutics in a research report on Monday, July 27th. JonesTrading lowered Capricor Therapeutics from a “buy” rating to a “hold” rating in a report on Friday, July 31st. Alliance Global Partners cut Capricor Therapeutics from a “buy” rating to a “neutral” rating and set a $7.00 price target for the company. in a research note on Tuesday, July 28th. Maxim Group downgraded Capricor Therapeutics from a “buy” rating to a “hold” rating in a report on Thursday, July 30th. Finally, HC Wainwright reaffirmed a “neutral” rating on shares of Capricor Therapeutics in a report on Monday, July 27th. One research analyst has rated the stock with a Buy rating, nine have assigned a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat, Capricor Therapeutics has a consensus rating of “Hold” and an average target price of $29.15.
Read Our Latest Analysis on CAPR
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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