CELECOR COMPLETES SUBMISSION OF FDA NEW DRUG APPLICATION FOR INVESTIGATIONAL HEART-ATTACK DRUG
Filing follows release of positive Phase 3 study results for zalunfiban (DisaggproTM);
company also appoints Chief Commercial Officer
DEL MAR, Calif., June 24, 2026 /PRNewswire/ -- CeleCor Therapeutics has submitted the final section of its New Drug Application for the company's investigational heart-attack drug, zalunfiban (DisaggproTM), to the U.S. Food and Drug Administration.
The NDA filing follows presentation in November of positive Phase 3 results from its CeleBrate study at the American Heart Association Scientific Sessions, as well as publication of the results in The New England Journal of Medicine Evidence.
The company also appointed Michael Moye as Chief Commercial Officer to lead commercial strategy and operations to support zalunfiban. Moye joins CeleCor after holding key leadership positions at companies including Idorsia, Shire and Johnson & Johnson.
Zalunfiban has FDA Fast Track status and was granted Rolling Review in January. This allows submission of documents and data as they become available, enabling regulators to begin their review early and creating the potential to shorten the review timeline.
The multinational CeleBrate study found that rapid zalunfiban treatment for STEMI heart attacks at first point of medical contact lowered risk of more severe heart damage in combination with other serious heart-attack complications. STEMI (ST-segment elevation) heart attacks are the most severe form of heart attack; the priority in treating them is opening the coronary artery as soon as possible to prevent death or irreversible heart damage.
About zalunfiban
Zalunfiban is an investigational agent; it has not been approved for any use and its safety and efficacy have not been established. Zalunfiban is a novel small-molecule inhibitor of the platelet GPIIb/IIIa receptor and was specifically designed for subcutaneous injection at the first point of medical contact for STEMI heart attacks.
About CeleCor Therapeutics
CeleCor Therapeutics was founded to improve the treatment of STEMI heart attacks at the first point of medical contact. For more updates, follow us on LinkedIn.
CONTACT: Rob Hillman, [email protected]
SOURCE CeleCor Therapeutics, Inc.
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