DEL MAR, Calif., Sept. 30, 2026 /PRNewswire/ — The U.S. Food and Drug Administration has accepted CeleCor Therapeutics’ New Drug Application (NDA) for zalunfiban (DisaggproTM) and assigned a target action date of June 18, 2027 under the Prescription Drug User Fee Act (PDUFA).
Zalunfiban is an investigational, subcutaneously injected inhibitor of the platelet GPIIb/IIIa receptor designed to treat patients with STEMI (ST-segment elevation) heart attacks, the most severe form of heart attack. The priority in treating STEMI heart attacks is to open the coronary artery as soon as possible to prevent death or irreversible heart damage.
“We look forward to working with the FDA as we seek approval for zalunfiban,” said Rob Hillman, President and CEO of CeleCor.