Aspire Biopharma submits pre-IND meeting request to FDA for sublingual aspirin

Aspire Biopharma (ASBP) announced that on November 3, 2025, it submitted its Pre-IND meeting request and briefing package to the U.S. Food and Drug Administration. The submission concerns the Company’s lead product candidate, a fast-acting, high-dose sublingual aspirin formulation for the treatment of suspected acute myocardial infarction and represents a significant milestone on the path to potential FDA approval. The Pre-IND meeting initiates formal dialogue with the FDA and is intended to gain agency guidance on the clinical development strategy and confirm the proposed 505(b)(2) regulatory pathway for Aspire’s sublingual aspirin.