Capricor shares fall 7.3% after wider-than-expected Q4 loss
Biotech company reports zero revenue but maintains strong $318M cash position ahead of August FDA decision
Capricor Therapeutics shares fell 7.3% on Friday after the biotechnology company reported a wider-than-expected fourth-quarter loss and no revenue, though investors remain focused on a pivotal regulatory decision due in August.
The Beverly Hills-based company reported a fourth-quarter loss of $0.62 per share, missing analyst expectations of $0.51 per share. Revenue dropped to zero from $11.1 million in the same period last year, as milestone payments from Capricor's distribution agreement with Nippon Shinyaku were fully recognized by the end of 2024.
The net loss for the quarter widened to approximately $30.2 million, compared with $7.1 million in the fourth quarter of 2024, driven by increased operating expenses related to commercial preparation activities. For the full year 2025, the company reported a loss of $2.26 per share on no revenue.
Despite the earnings miss, Capricor's financial position strengthened considerably. Cash, cash equivalents and marketable securities totaled $318.1 million as of December 31, 2025, more than double the $151.5 million balance a year earlier. The company said this capital is expected to fund operations through 2027, providing runway beyond the upcoming regulatory decision for its lead therapy.
Investor attention remains centered on deramiocel, Capricor's investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy. The U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026, marking when the agency plans to complete its review of the therapy's Biologics License Application.
The FDA lifted a Complete Response Letter issued in July 2025 and classified the resubmission as a Class 2 review, following additional data submissions from the company. The BLA is supported by positive data from the Phase 3 HOPE-3 clinical trial, which demonstrated reduced progression of myocardial fibrosis and significant improvement in left ventricular ejection fraction compared to placebo.
The Global Statistical Test composite endpoint, which included Performance of Upper Limb, left ventricular ejection fraction and Patient Global Impression of Severity, showed an overall statistically significant treatment benefit favoring deramiocel. The therapy has received multiple regulatory designations, including Orphan Drug designation from both the FDA and European Medicines Agency, Regenerative Medicine Advanced Therapy designation in the U.S., and Rare Pediatric Disease designation from the FDA.
Analysts have maintained bullish outlooks despite the earnings shortfall. HC Wainwright & Co. reiterated a "Buy" rating with a $60 price target, while Piper Sandler reaffirmed its "Overweight" rating and raised its price target to $58 from $45. Cantor Fitzgerald maintained an "Overweight" rating with a $62 target, and B. Riley adjusted its target to $63 from $50 while keeping a "Buy" rating.
The consensus recommendation from 10 brokerage firms rates Capricor as "Outperform," with an average target price of $53.40, suggesting significant upside from the current trading level of approximately $31. The stock has traded between $4.30 and $40.37 over the past 52 weeks.
Capricor's in-house GMP manufacturing facility has successfully completed an FDA pre-license inspection and is prepared to meet initial commercial demand of approximately 250 patients per year, with plans for expansion to support up to 2,500 patients annually. The company also received approval for uplisting to the Nasdaq Global Select Market on March 9, the exchange's highest listing tier.
The upcoming FDA decision represents a critical milestone for the company, with deramiocel positioned to address a significant unmet medical need in Duchenne muscular dystrophy, a rare genetic disorder that affects approximately 1 in 3,500 male births worldwide.