Why is Capricor Therapeutics stock gaining today?

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.

Capricor Therapeutics (CAPR) is shifting its focus to a narrower upper limb skeletal muscle indication after an FDA advisory committee rejected its initial cardiomyopathy treatment bid. The company reported Q2 net loss of $40.7M, with cash reserves declining to $237.9M. Positive data from the HOPE-3 trial supports the new strategy, but regulatory timelines are extended. The FDA will review the amended BLA, and Capricor is exploring regulatory paths in Europe and Japan.