Aspire Biopharma Holdings Inc. has announced a successful Type B pre-Investigational New Drug $(IND)$ meeting with the U.S. Food and Drug Administration (FDA) regarding its investigational product, acetylsalicylic acid 162 mg sublingual powder (OTASA), intended for the emergency treatment of suspected acute myocardial infarction. The FDA provided feedback supporting a 505(b)(2) regulatory filing targeted for the second half of 2026 and indicated that no additional studies are required beyond the currently planned 32-subject clinical trial. Initial evaluations of OTASA have indicated that the product was safe and well-tolerated with no reported adverse events. Results from the planned clinical trial have not yet been presented.

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: 1124593) on January 07, 2026, and is solely responsible for the information contained therein.