<p>Aspire Biopharma Holdings Inc. has submitted a Pre-IND meeting request and briefing package to the U.S. Food and Drug Administration (FDA) for its lead product candidate, a fast-acting, high-dose sublingual aspirin formulation intended for the treatment of suspected acute myocardial infarction (heart attack). This submission marks an important step in seeking FDA guidance on the clinical development strategy and confirmation of the proposed 505(b)(2) regulatory pathway. No grant or funding involving Aspire or multiple organizations is mentioned. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aspire Biopharma Holdings Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1112553) on December 02, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)</p>

ASBP

<p>Aspire Biopharma Holdings Inc. has submitted a Pre-IND meeting request to the FDA for its sublingual aspirin product aimed at treating acute myocardial infarction. This step seeks FDA guidance on clinical development and the 505(b)(2) regulatory pathway. The news was published by Aspire via ACCESS Newswire on December 02, 2025.</p>

Aspire Biopharma Submits Pre-IND Meeting Request to FDA for Sublingual Aspirin Product