DEL MAR, Calif., June 24, 2026
CeleCor Therapeutics announced the completion of its New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zalunfiban (Disaggpro™), the company’s investigational therapy designed for the rapid treatment of ST-segment elevation myocardial infarction (STEMI), the most severe form of heart attack. The regulatory filing marks a significant milestone for the clinical-stage biotechnology company and follows the presentation of positive Phase 3 results from the CeleBrate study at the American Heart Association Scientific Sessions as well as publication of the data in The New England Journal of Medicine Evidence. The NDA submission positions zalunfiban for FDA review as a potential new treatment option aimed at reducing heart damage and improving outcomes when administered at the earliest stages of a heart attack.
Phase 3 CeleBrate Trial Demonstrated Clinical Benefit
The NDA filing is supported by results from the multinational Phase 3 CeleBrate trial, which evaluated the effectiveness of zalunfiban in patients experiencing STEMI heart attacks. The study demonstrated that rapid administration of zalunfiban at the first point of medical contact reduced the risk of more severe heart muscle damage when used alongside standard-of-care therapies. STEMI heart attacks occur when a coronary artery becomes completely blocked, requiring immediate intervention to restore blood flow and minimize irreversible cardiac injury. Researchers reported that early treatment with zalunfiban helped improve clinical outcomes by addressing platelet-driven clot formation during the critical early phase of a heart attack. The positive trial findings provided the foundation for the company’s regulatory submission and support the potential role of zalunfiban in emergency cardiovascular care.
FDA Fast Track and Rolling Review Support Accelerated Development
CeleCor’s regulatory strategy has benefited from the FDA’s Fast Track designation for zalunfiban, reflecting the significant unmet medical need in acute STEMI treatment. In January, the investigational therapy was granted Rolling Review, allowing the company to submit sections of its NDA as they became available rather than waiting for the entire application package to be completed. This approach enables FDA reviewers to begin evaluating critical clinical, manufacturing, and safety data earlier in the review process, potentially shortening the overall timeline for regulatory decision-making. The completion of the final NDA section represents the culmination of years of clinical development and moves the program into a new phase focused on regulatory assessment and potential commercialization.
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CeleCor Strengthens Commercial Leadership Ahead of Potential Launch
In preparation for a potential market introduction, CeleCor Therapeutics has appointed Michael Moye as Chief Commercial Officer to lead commercial strategy and operational planning for zalunfiban. Moye brings extensive pharmaceutical leadership experience from previous roles at Idorsia, Shire, and Johnson & Johnson, where he helped guide product launches and commercialization initiatives. Zalunfiban is a novel small-molecule inhibitor of the platelet GPIIb/IIIa receptor specifically engineered for subcutaneous administration during the earliest stages of a STEMI event. Designed to be delivered at the first point of medical contact, the therapy aims to rapidly inhibit platelet aggregation and support faster intervention before patients reach specialized cardiac treatment centers. With NDA submission now complete, CeleCor is advancing toward a potentially transformative milestone that could introduce a new treatment option for patients suffering from life-threatening heart attacks while expanding innovation in acute cardiovascular medicine.
Source: CeleCor Therapeutics press release
