Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin (OTASA)

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
Stocktwits on MSN

ASBP stock soars 32% after favorable feedback from FDA for its aspirin – retail expects licensing negotiations soon

Aspire does not expect to conduct additional studies beyond its currently planned multicenter crossover clinical trial. ・The ...
Investing.com India

Aspire Biopharma stock soars after FDA meeting clears path for heart attack drug

Investing.com -- Aspire Biopharma Holdings Inc (NASDAQ:ASBP) stock surged 60.6% in premarket trading Wednesday after the ...

Aspire Biopharma Holdings, Inc.: Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial ESTERO, FL / / January 7, 2026 / Aspire Biopharma Holdings ...
Columbia Daily Tribune

Aspire Biopharma Submits Pre-IND Meeting Request and Briefing Package to U.S. FDA for Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart ...

ESTERO, FLORIDA / ACCESS Newswire / December 2, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (“Aspire” or the “Company”), a developer of a multi-faceted patent-pending drug delivery technology ...
Seeking Alpha

Aspire Biopharma Announces Milestone Roadmap Targeting H2 2025 FDA Submission for Sublingual Aspirin and Key 2026 Milestones for Needle-Free Semaglutide (Diabetes, Weight ...

H2 2025: Request meeting with FDA to discuss 505(b)(2) pathway. H2 2025: Target submission of New Drug Application (NDA). Sublingual ED medication H1 2026: Finalize formulation and manufacture test ...
KELOLAND News

Aspire Biopharma Announces Milestone Roadmap Targeting H2 2025 FDA Submission for Sublingual Aspirin and Key 2026 Milestones for Needle-Free Semaglutide (Diabetes, Weight ...

H1 2026: Finalize formulation and manufacture test product. H1 2026 Initial Phase 1 pharmacokinetic clinical cross-over study. "Our pipeline is focused on research in therapeutic areas where we can ...