Aspire Biopharma targets 2H25 FDA submission for sublingual aspirin

Aspire Biopharma (ASBP) Holdings announced pipeline progress and key milestones expected through the remainder of 2025 and early 2026. The company is focusing its pipeline on reformulating approved drugs for multi-billion-dollar markets by utilizing its disruptive, patent-pending sublingual delivery technology. Anticipated Upcoming Milestones: Sublingual High-dose Aspirin: H2 2025: Request meeting with FDA to discuss 505(b)(2) pathway. H2 2025: Target submission of New Drug Application. Sublingual ED medication: H1 2026: Finalize formulation and manufacture test product. Mid-2026: Initiate Phase 1 pharmacokinetic clinical cross-over study. Sublingual Semaglutide: 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 increase speed to bioavailability, reduce the incidence of side effects and improve patient compliance of approved drugs,” said Kraig Higginson, Interim CEO of Aspire Biopharma. “By utilizing our disruptive sublingual drug delivery to develop new formulations of known generic drugs, we believe Aspire can provide improved patient outcomes and treatment options for many existing drugs that currently generate multi-billion-dollar sales for large pharmaceutical companies.”