Capricor Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - 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 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.

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.