Aspire Biopharma Holdings Inc Stock Price, News & Analysis

Aspire Biopharma Holdings (NASDAQ:ASBP) has completed patient dosing in its Phase 1 clinical trial for its oral transmucosal fast-acting high-dose aspirin formulation. The study compares the company's sublingual 162.5 mg aspirin powder against traditional oral aspirin in healthy adult volunteers.

The trial evaluates plasma acetylsalicylic acid concentration, Arachidonic acid-induced platelet aggregation, and Serum thromboxane B2 measurements to assess the formulation's rapid impact on cardiac events. Topline results are expected by mid-Q3 2025, after which Aspire plans to pursue a section 505(b)(2) NDA and explore potential partnership opportunities.

Aspire Biopharma Holdings (NASDAQ: ASBP) has appointed Michael C. Howe as its new Chief Executive Officer, effective June 10, 2025. Howe, who currently serves as an Independent Board Member, brings over four decades of experience in healthcare and consumer brands. His notable achievements include transforming MinuteClinic from 19 clinics to over 530 locations after its CVS acquisition, delivering a sixfold return for investors. Former CEO Kraig Higginson will transition to Executive Chairman. Howe's appointment comes at a crucial time as Aspire advances its drug delivery technology platform, conducts FDA clinical trials for high-dose aspirin via the 505(b)(2) pathway, and prepares to launch its pre-workout supplement, BUZZ BOMB™, in 2025.

Aspire Biopharma Holdings (NASDAQ: ASBP) has announced the upcoming launch of BUZZ BOMB™, a novel sublingual pre-workout supplement, in Q3 2025. The product features 50mg of caffeine delivered through proprietary sublingual nano technology, offering rapid absorption directly into the bloodstream. Initial production has begun with six flavor options, including Tropical Fruit, Mixed Berry, Watermelon, Lemon Lime, Peach Mango, and Mocha Coffee. The company plans expanded pre-launch consumer testing in Q2 2025 and will showcase the product at two major fitness conventions in August 2025. BUZZ BOMB™ differentiates itself through immediate effectiveness, convenient single-serving packets, and on-demand energy management. The global pre-workout supplements market is projected to reach $27.97 billion by 2030, with a CAGR of 5.9% from 2025-2030.

Aspire Biopharma Holdings (NASDAQ: ASBP) has initiated its Phase 1 clinical trial for its lead product, a novel oral transmucosal fast-acting high-dose aspirin formulation. The single-center U.S. trial has dosed its first patient and aims to evaluate safety, pharmacokinetics, and pharmacodynamics. The study will compare a 162.5 mg sublingual aspirin powder/granules against conventional oral aspirin in healthy adult volunteers. The trial's primary focus is measuring plasma acetylsalicylic acid concentration over 24 hours, along with TxB2 and anti-coagulant bioavailability data. Completion is expected by mid-June 2025, with topline data anticipated in early Q3 2025. If successful, the trial could support accelerated FDA approval.

Aspire Biopharma Holdings (NASDAQ:ASBP), a developer of patent-pending drug delivery technology, has announced its participation in the upcoming Sidoti Virtual Investor Conference. CEO Kraig Higginson will deliver a presentation on May 21, 2025, at 2:30 PM Eastern. The company will also host one-on-one meetings with investors on May 21-22, 2025.

Interested participants can access the virtual presentation through Sidoti's registration link, and a replay will be available on Aspire's investor relations website. This conference provides an opportunity for investors to learn more about Aspire's multi-faceted drug delivery technology and engage directly with management.

Aspire Biopharma (Nasdaq: ASBP) has received Institutional Review Board (IRB) approval for its Phase I clinical trial of a novel oral transmucosal fast-acting high-dose aspirin formulation. The trial, set to begin this week, will involve 6-8 participants at a single U.S. center.

The study will compare a 162.5 mg sublingual aspirin powder against standard oral aspirin in healthy adult volunteers, measuring plasma acetylsalicylic acid concentration over 24 hours. This innovative delivery method aims to bypass first-pass metabolism through oral mucosa absorption.

The company plans to pursue FDA fast-track approval via a 505(b)(2) NDA for treating suspected acute myocardial infarction. Previous research has shown aspirin treatment reduced vascular mortality risk by 23% in MI patients. The new formulation could potentially offer improved bioavailability while limiting gastric irritation associated with traditional aspirin delivery.

Aspire Biopharma Holdings (Nasdaq: ASBP) has announced its upcoming presentation at the Emerging Growth Conference on April 17, 2025, at 12:35 p.m. EDT. CEO Kraig Higginson will deliver a corporate presentation followed by Q&A.

The virtual event comes after the company's recent initiation of a Phase 1 single-center clinical study for their lead therapeutic candidate - an oral transmucosal fast-acting high-dose aspirin formulation. The study aims to determine optimal drug product formulation and guide potential subsequent clinical trials.

Following the trial completion, Aspire plans to schedule a pre-IND meeting with the FDA in Q2 2025. The company intends to pursue a section 505(b)(2) NDA approval for treating suspected acute myocardial infarction.

Aspire Biopharma Holdings (NASDAQ:ASBP) has initiated production of its single-dose pre-workout supplement utilizing its patent-pending sublingual delivery technology. The supplement, featuring 100mg of caffeine and beta alanine, will be packaged in convenient single-serving sachets that don't require water mixing.

The company plans to conduct consumer and safety testing in Q2 2025, with the product expected to launch in specialty nutritional retailers in 2025. Desert Stream Inc., a leading private label manufacturer, is handling the initial production. The supplement will be available in at least three flavors.

The product enters a growing market, with global pre-workout supplements valued at USD 19.90 billion in 2023 and projected to reach USD 29.77 billion by 2032, growing at a 4.58% CAGR. The market growth is driven by increasing fitness awareness, rising demand for performance-enhancing nutritional products, and growing fitness center numbers.

Aspire Biopharma Holdings (NASDAQ:ASBP) has initiated a Phase 1 clinical trial for its oral transmucosal fast-acting high-dose aspirin formulation. The single-center study will evaluate safety, pharmacokinetics, and pharmacodynamics of their sublingual aspirin powder.

The trial will enroll 6-8 participants in April 2025, comparing a 162.5mg sublingual aspirin powder dose against conventional oral aspirin. The primary outcome measure focuses on plasma acetylsalicylic acid concentration over 24 hours.

The company plans to request a pre-IND FDA meeting in Q2 2025 to discuss development plans for a 505(b)(2) NDA submission. The product aims to treat suspected acute myocardial infarction, with potential benefits including rapid absorption, improved bioavailability, and reduced gastric irritation. Initial clinical data is expected by the end of Q2.