Capricor Therapeutics

Capricor Therapeutics shares rose about 9.2% in premarket trading to $9.14 after B. Riley raised its rating from “Neutral” to “Buy” and lifted its price target from $5 to $21. B. Riley sees an asymmetric opportunity ahead of the PDUFA date on November 22, 2026, for the cell‑therapy candidate Deramiocel and cites the World Muscle Society conference on October 3 as a near‑term catalyst. Earlier positive ratings from Cantor Fitzgerald, Piper Sandler and Oppenheimer, as well as the FDA’s acceptance of a major amendment to the BLA, support the optimistic view. » Więcej na de.investing.com

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. » Więcej na 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. » Więcej na finance.yahoo.com