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Aspire Biopharma Holdings Inc (ASBPW) delivers cutting-edge updates on its pioneering sublingual drug delivery systems and therapeutic developments. This dedicated news hub provides investors and healthcare professionals with timely access to official press releases, clinical trial progress, and regulatory milestones.
Discover comprehensive coverage of ASBPW's innovative formulations, including high-dose aspirin for cardiac emergencies, combination therapies, and nutraceutical advancements. Our curated repository ensures transparent access to strategic partnerships, intellectual property developments, and market expansion initiatives.
Key updates are organized for efficient navigation, featuring critical developments in FDA engagement, nanotechnology applications, and product commercialization. Bookmark this page for direct access to Aspire Biopharma's verified announcements, maintaining your competitive edge in tracking biopharmaceutical innovation.
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.
Aspire Biopharma Holdings (NASDAQ:ASBP) announced that Glatt Air Techniques has completed the first GMP Clinical Batch of its pharmaceutical-grade oral mucosal fast-acting aspirin formulation. The company plans to initiate bioavailability studies in healthy volunteers in April 2025.
The lead product candidate is a high-dose sublingual aspirin in granular or powder form, designed for cardiology emergencies and pain management. The patent-pending delivery system enables rapid sublingual absorption, bypassing the gastrointestinal tract.
Key upcoming milestones include:
- Initial FDA meeting in Q2 2025
- Pharmacodynamic effect clinical trial in Q2 2025
- Fast track approval request for high-dose aspirin
- Clinical trials for low-dose preventative care in Fall 2025
- Expected FDA approval for pain relief application in late 2025
Aspire Biopharma Holdings (NASDAQ:ASBP) has provided an update on two patent applications filed with the USPTO for its Oral Mucosal Formulations of Aspirin. The applications, filed on March 31, 2023, and October 2, 2024, focus on the company's fast-acting sublingual drug delivery platform.
The company's lead product candidate is a high-dose sublingual aspirin in granular or powder form, designed for cardiology emergencies and pain management. Key upcoming milestones include:
- Bioavailability study initiation (April 2025)
- Pre-IND FDA meeting (Q2 2025)
- Pharmacodynamic clinical trial (Q2 2025)
- FDA fast-track approval request
- Low-dose aspirin trials (Fall 2025)
- High-dose pain relief NDA submission (late 2025)
The technology offers advantages including rapid absorption, water solubility, improved dosage management, and bypass of the digestive tract.
Aspire Biopharma Holdings (NASDAQ:ASBP) has announced plans to launch a new single-dose pre-workout supplement in 2025, utilizing their patent-pending sublingual delivery technology. The company has partnered with Desert Stream Inc., a nutritional supplement manufacturer, for ingredient sourcing, lab studies, and quality control.
The innovative product will be available in a convenient sachet format with at least three flavors, designed for rapid absorption through sublingual delivery - a significant departure from traditional powder-water mix supplements. This launch targets the global pre-workout supplements market, valued at $19.90 billion in 2023 and projected to reach $29.77 billion by 2032, growing at a 4.58% CAGR.
The product aims to address timing issues with traditional caffeine-based pre-workout supplements, which typically require 30-minute lead time and go through digestive processing. Aspire's sublingual delivery method promises better user control over workout enhancement timing and delivery.
Aspire Biopharma Holdings (NASDAQ:ASBP) announced the completion of initial feasibility studies for its high-dose sublingual aspirin product, with Phase 1 clinical trials expected to begin in April 2025. The company's lead product candidate is a granular or powder formulation of soluble, Ph neutral, fast-acting aspirin designed for cardiology emergencies and pain management.
Testing conducted by Glatt Air Techniques validated analytical methods, ingredient purity, compatibility, stability, and flavor profiles. The company believes its sublingual delivery technology enables rapid absorption into the bloodstream, potentially offering quick intervention for heart attacks and strokes, along with effective pain management applications.
Aspire outlined its 2025 milestones, including FDA meetings, clinical trials for both high and low-dose aspirin products, and development of non-aspirin prescription formulations (testosterone, semaglutide, migraine relief, erectile dysfunction) and non-prescription products (pre-workout supplements, melatonin, vitamins).
Aspire Biopharma (Nasdaq: ASBP) has entered into a Securities Purchase Agreement on February 19, 2025, issuing a senior secured convertible debenture that will generate $3.0 million in gross proceeds. The debenture is convertible only in case of default or at the company's discretion.
The transaction, expected to close on February 20, 2025, includes investor volume restrictions limiting sales to 15% of daily volume. The proceeds will support general working capital and operating expenses. Notably, the structure avoids warrants or resets typically associated with DESPAC transactions.
Dawson James Securities and RBW Capital Partners are serving as exclusive placement agents, with ArentFox Schiff LLP and Sichenzia Ross Ference Carmel LLP providing legal counsel to the placement agent and company respectively.
Aspire Biopharma Holdings has completed its business combination with PowerUp Acquisition Corp, creating a Nasdaq-listed biopharmaceutical company. The company will trade under the ticker symbol 'ASBP' starting February 20, 2025. The transaction raised approximately $3.8 million through PowerUp's trust account and PIPE financing.
Aspire focuses on developing breakthrough innovations in FDA-approved drugs using its proprietary sublingual delivery system. Their pipeline includes a fast-acting aspirin product for cardiology emergencies, a Viagra/Cialis combination, and various bi-hormonal drugs. The company's patented technology enables rapid absorption of drugs directly into the bloodstream, bypassing the gastrointestinal tract and liver.
Led by CEO Kraig Higginson, Aspire plans to use the proceeds to accelerate development of its product pipeline and advance clinical trials, particularly for its lead product - an 'instant absorption' aspirin formulation.
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