Capricor Therapeutics stock rises on Piper Sandler upgrade

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) 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.

Capricor Therapeutics Inc (CAPR) shares rose 15.7% after Oppenheimer upgraded the stock to Outperform with a $54 price target. The FDA accepted new material for its deramiocel treatment, setting a new PDUFA date of November 22. The company plans to disclose 24-month trial data before this date. Oppenheimer cited the FDA's positive signal and potential approval prospects.

Picard Medical (PMI) rose 40% after reporting Q2 revenue growth of 39% to $3.0M. Sadot Group (SDOT) surged 100% despite zero revenue, with net income up to $35.2M. Capricor Therapeutics (CAPR) gained 11% after FDA extended review for deramiocel. GRI Bio (GRI) climbed 10% with Phase 2a data selected for ERS 2026. Biomea Fusion (BMEA) rose 14% after completing Phase 2 diabetes trial enrollment. Yarrow Bioscience (YARW) advanced 12% with Graves' disease trial updates.

FDA extended Capricor Therapeutics' deramiocel review to November 22, 2026, after the company submitted a major amendment with 24-month HOPE-3 study data. HC Wainwright maintained a Neutral rating, citing high regulatory risk. The firm will reassess after more regulatory information is available.