Capricor Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update

Capricor Therapeutics reported a Q3 net loss of $42.7M, widening from $24.6M a year earlier. The company highlighted positive data on Deramiocel, its lead therapy, showing improved upper limb function in patients. Capricor is preparing for a potential launch while resolving a distribution dispute with Nippon Shinyaku. The company has sufficient cash to fund operations for at least 12 months.

Capricor (CAPR) stock rose after-hours as the company reaffirmed confidence in its Deramiocel treatment ahead of a November 22 decision. The HOPE-3 trial met its primary endpoint, showing a 1.1-point improvement in upper limb function. Capricor reported a Q3 net loss of $42.7 million and $198.5 million in cash reserves. Retail sentiment on StockTwits was extremely bullish, with mixed opinions on approval odds. CAPR stock is down 69% year-to-date.

Capricor Therapeutics reported that the HOPE-3 trial's key secondary endpoint, change in LVEF, did not reach statistical significance. The company's BLA for the treatment remains under FDA review, with a PDUFA target action date of November 22, 2026, according to Capricor.

Capricor Therapeutics (CAPR) shares rose 14% after clinical investigators urged the FDA to approve Deramiocel for Duchenne muscular dystrophy. The FDA will decide by November 22. CAPR stock has gained 29% this week. The investigators highlighted trial results and the lack of approved therapies for non-ambulatory patients.

Capricor (CAPR) reported that Deramiocel slowed arm and hand function decline by 76% in patients. The FDA is reviewing the data. CAPR has $237.9M in cash. Retail traders on Stocktwits are mixed ahead of the FDA decision. CAPR stock is down 78% YTD.

Oppenheimer reiterated an Outperform rating and $54 price target for Capricor Therapeutics (CAPR) after a webinar on FDA data, citing robust HOPE-3 trial results. The stock is down 74% in six months. Other analysts also upgraded CAPR, with targets up to $25, anticipating regulatory milestones.