Capricor jumps as study shows longer-term effects of deramiocel (CAPR:NASDAQ)

Capricor Therapeutics (CAPR) shares dropped 8% on Friday as investors await the FDA's decision on its drug Deramiocel. The FDA's target action date is Saturday. The company plans to submit an amendment with additional data. Activist shareholder Kaos Capital is pushing for a board shakeup and cost-cutting measures. CAPR stock is down 78% year-to-date.

Capricor Therapeutics (CAPR) stock surged 9.2% pre-market to $9.14 after B.Riley upgraded it to Buy with a $21 price target, up from $5. The firm cited the potential of deramiocel, an investigational cell therapy for Duchenne muscular dystrophy, ahead of a key FDA decision in November 2026. B.Riley's reversal follows upgrades from other analysts, with Cantor Fitzgerald, Piper Sandler, and Oppenheimer also bullish on the stock. The rally occurred despite a broader market decline, highlighting the

B. Riley upgraded Capricor Therapeutics (CAPR) to Buy from Neutral, raising its price target to $21 from $5. The analyst anticipates potential re-rating before the FDA decision on November 22, with data possibly released at the World Muscle Society conference on October 3. B. Riley sees 50% upside in a positive scenario and expects shares to hold near current levels in a negative scenario.

Capricor Therapeutics (CAPR) stock surged 144% in a month due to positive phase III data for its cell therapy deramiocel, renewed FDA engagement, and a refined regulatory pathway. The FDA accepted additional data and extended the PDUFA date to November 22, 2026, focusing on upper-limb function. Investors are optimistic despite regulatory risks, with the upcoming FDA decision being a major catalyst.

Capricor Therapeutics (NASDAQ:CAPR) received a 3-month FDA review extension for deramiocel, its Duchenne muscular dystrophy therapy, after submitting new 24-month data. The FDA accepted the submission, citing high unmet medical need. The company shifted focus to upper limb function, where it reported positive trial results. Shares rose 15% to $7.25 post-announcement.

Capricor Therapeutics (CAPR) shares rose 5.5% premarket after Piper Sandler upgraded it to Overweight and raised its price target to $25. The upgrade follows an FDA review extension for deramiocel, with data showing a 4.55% difference in upper limb function improvement. Piper Sandler notes potential upside if approved by the November 22 PDUFA date. Capricor had $238 million in cash at Q2 fiscal 2026.