Capricor Therapeutics

Capricor Therapeutics stock is gaining in pre-market trading, supported by the FDA’s willingness to accept a revised marketing application for Deramiocel for review, focusing on upper-limb function in Duchenne patients. Cantor Fitzgerald upgraded the stock to “Overweight” and sharply raised its price target, while Oppenheimer continues to rate it “Outperform.” The company reported cash and equivalents of about $237.9 million, enough to fund operations for at least 12 months, and investor speculation is increasing ahead of the PDUFA decision on November 22, 2026. » Más en de.investing.com

After an FDA advisory committee voted against approval for cardiomyopathy in Duchenne muscular dystrophy, Capricor will amend its BLA to pursue an upper-limb skeletal muscle indication supported by the HOPE-3 primary endpoint. The HOPE-3 data showed a statistically significant 4.5% slowing of upper-limb decline and supportive safety data from over 1,300 infusions, but a key secondary ejection-fraction result weakened under revised analysis. Financially, cash fell to $237.9 million and Q2 net loss widened to $40.7 million as operating costs rose, while short interest remains elevated at about 33.7% of float. » Más en finance.yahoo.com

Capricor Therapeutics shares rose 15.7% after Oppenheimer upgraded the stock from “Perform” to “Outperform” and set a $54 price target. The move follows new FDA information on Deramiocel for treating Duchenne muscular dystrophy; the FDA accepted submitted documents as a substantive amendment and set a new PDUFA date of November 22. Analyst Leland Gershall now sees improved approval chances, noting the agency could consider an indication for upper-limb function, which corresponds to the primary endpoint of the Phase 3 study. Capricor plans to release additional 24‑month data from the HOPE-3 study and further information ahead of the PDUFA date. » Más en de.investing.com