🟢 Capricor Therapeutics is trading 11.29% up today after FDA extends deramiocel PDUFA date

Capricor Therapeutics is trading 11.29% up now at $7.00 after the FDA extended deramiocel’s PDUFA target action date from August 22, 2026, to November 22, 2026.

• The three-month extension allows review of a major BLA amendment containing 24-month HOPE-3 follow-up data, additional analyses, and a refined proposed indication focused on upper-limb function.
• Shares rose following the announcement despite mixed broader markets; the FDA cited significant unmet medical need and accepted the amendment for review, though approval remains uncertain.