Aspire Biopharma shares surge 11.34% premarket after submitting FDA Pre-IND for sublingual aspirin, citing rapid pharmacology and 505(b)(2) pathway pursuit.

Aspire Biopharma surged 11.34% in premarket trading following the announcement that it submitted a Pre-IND meeting request and briefing package to the U.S. FDA for its sublingual aspirin product targeting acute myocardial infarction. The submission marks a critical regulatory milestone, initiating formal dialogue with the FDA to confirm a 505(b)(2) pathway for the product, which could streamline development and reduce costs. The company highlighted clinical trial results showing its formulation inhibits platelet aggregation four to five times faster than chewed aspirin, with statistically significant improvements in plasma ASA levels and reduced TxB2 biomarkers. This rapid pharmacological action, coupled with safety and tolerability data, underscores the product’s potential to address a large patient population, reinforcing investor optimism. The news directly aligns with the stock’s bullish premarket movement.