$CAPR

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 (CAPR) faces a class action lawsuit for alleged securities law violations. The complaint claims the company made false statements regarding changes to its clinical data analysis and FDA approval process for Deramiocel. Shareholders who purchased shares between December 17, 2025, and July 26, 2026, are encouraged to contact DJS Law Group by September 28, 2026, to discuss potential lead plaintiff roles.

Capricor Therapeutics (CAPR) faces a class action lawsuit alleging it changed the statistical analysis plan for its Phase 3 HOPE-3 trial without FDA agreement, leading to a 78.7% stock drop. The FDA deemed results 'post-hoc and exploratory,' and an advisory committee voted against deramiocel's efficacy. The lawsuit covers investors who bought shares between December 17, 2025, and July 26, 2026.

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.

Several biotech stocks are trading higher in premarket, including Autonomix Medical (AMIX) up 29% at $6.92, Picard Medical (PMI) up 12% at $5.85, and others. The gains indicate early momentum and potential volatility for the trading day, according to the market activity.

Capricor Therapeutics (CAPR) faces a securities fraud lawsuit over alleged misstatements about its Deramiocel clinical data, leading to a 64.5% stock drop. The FDA raised concerns about changes to the statistical analysis plan, and an advisory committee voted against its efficacy. Investors have until September 28, 2026, to join the class action.

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.

Capricor Therapeutics (CAPR) stock rose 2.6% after the FDA extended its review period for Deramiocel to November 22, 2026, due to new data submission. Shares initially surged to $8.015 but retreated amid broader market declines and regulatory concerns. Analysts have mixed views, with Cantor Fitzgerald targeting $28. The stock's 52-week range is $2.96 to $40.37.

Capricor Therapeutics (CAPR) shares rose 29% after the FDA extended the review period for its Deramiocel BLA to November 22, 2026. The extension follows the submission of additional Phase 3 HOPE-3 data supporting a refined indication for Duchenne muscular dystrophy. The FDA accepted the amendment, citing significant unmet medical need.