Welcome to our dedicated page for Aspire Biopharma Holdings news (Ticker: ASBP), a resource for investors and traders seeking the latest updates and insights on Aspire Biopharma Holdings stock.
Aspire Biopharma Holdings Inc (ASBP) delivers cutting-edge sublingual drug delivery solutions designed to transform patient care through rapid-acting formulations. This news hub provides investors and industry professionals with timely updates on regulatory milestones, clinical advancements, and strategic developments.
Access authoritative reporting on ASBP's innovative pipeline, including nanotechnology-enhanced medications for cardiology emergencies, pain management, and hormonal therapies. Track progress on FDA-reviewed products, manufacturing partnerships, and intellectual property expansions that demonstrate the company's scientific leadership.
Our curated news collection features earnings announcements, research breakthroughs, and market analyses relevant to ASBP's mission of improving drug bioavailability. Bookmark this page for direct access to primary-source updates about sublingual delivery innovations shaping the future of biopharmaceuticals.
Aspire Biopharma (Nasdaq: ASBP) completed a Type B pre-IND meeting with the FDA on January 7, 2026, receiving written feedback that supports a Section 505(b)(2) NDA filing in H2 2026 after a planned clinical trial.
The company will run a multicenter crossover study in 32 healthy volunteers comparing OTASA 162 mg sublingual powder vs. two chewed 81 mg aspirin tablets, measuring serum thromboxane B2 (TxB2) inhibition. Pilot data showed faster ASA absorption, TxB2 inhibition within two minutes, and no reported adverse events. Management said the FDA alignment de-risks the regulatory path and could support a breakthrough therapy request.
Aspire Biopharma (Nasdaq: ASBP) announced on December 18, 2025 that elite ultra-runner and Ironman champion Ashley Paulson is joining as global Brand Ambassador for BUZZ BOMB®, Aspire's sublingual caffeine product.
Paulson's credentials include 130+ marathons, 25+ Ironman-distance triathlons, multiple ultra triathlons, two 281.2-mile events, 6+ 100-mile races, Badwater 135 Women’s Champion (2022) and Overall Champion (2023). Aspire says Paulson will lead digital campaigns, exclusive training content, and represent BUZZ BOMB at major endurance events in 2026. BUZZ BOMB is positioned as near-instant sublingual caffeine for rapid energy without digestive upset. Paulson's social reach is listed as ~174,000 Instagram, 23,000 TikTok, and 12,000 Facebook followers.
Aspire Biopharma (Nasdaq: ASBP) received a notice from the Nasdaq Hearings Panel granting an extension to continue its Nasdaq listing, subject to conditions after the Company's transfer to the Nasdaq Capital Market.
The company will transfer its common stock listing effective at market open on December 15, 2025, retain the symbol ASBP, and must demonstrate compliance with the Bid Price Rule (Rule 5550(a)(2)) by January 30, 2026 and the Equity Rule (Rule 5550(b)(1)) by February 17, 2026. Management said it expects to cure the bid-price and market-value deficiencies and is working to recapitalize the balance sheet.
Aspire Biopharma (Nasdaq:ASBP) provided a Q3 2025 business update highlighting clinical, regulatory, IP, commercial, and manufacturing progress.
Key disclosed developments: the company reported positive final bioavailability data for its sublingual high-dose aspirin showing platelet inhibition in under 2 minutes (about 4–5x faster than chewed aspirin); filed an omnibus patent application covering its sublingual delivery platform; received a positive FDA response to its Pre-IND request with written feedback due by Jan 2, 2026; and raised commercial capacity with an initial production order of 2 million servings of BUZZ BOMB™ caffeine ahead of a consumer e-commerce launch. The company targets an NDA submission in H1 2026 for the sublingual aspirin program.
Aspire Biopharma (NASDAQ:ASBP) said it submitted a Pre-IND meeting request and briefing package on November 3, 2025 to the U.S. FDA for its lead product: a fast-acting, high-dose sublingual aspirin for suspected acute myocardial infarction (AMI).
Company-reported trial results claim the formulation begins to inhibit platelet aggregation in under two minutes, acting 4–5× faster than chewed aspirin, with higher mean plasma ASA and reduced serum TxB2 within two minutes; the product was described as safe and well-tolerated. Aspire intends to pursue a 505(b)(2) regulatory pathway toward a future NDA.
Aspire Biopharma (NASDAQ:ASBP) announced the November 4, 2025 hire of Mark J. Jaroszeski, PhD to its scientific team. Dr. Jaroszeski is a tenured professor of Medical Engineering at the University of South Florida with a PhD in Engineering Science and a long record in DNA and drug delivery, including early in vivo electroporation work, 34 U.S. patents, and leadership roles in academic and startup research.
The company said his expertise will support development and optimization of Aspire's patent-pending sublingual delivery technology and help extend the platform across its pipeline of generic medicines.
Aspire Biopharma (Nasdaq:ASBP) reported its participation at CPHI Frankfurt (Oct 27-30, 2025), where management held 16 formal face-to-face meetings and dozens of informal discussions with global pharmaceutical companies including Bayer, Deva Holdings, Abiogan, Key Pharmaceuticals, TGC Health, Instapill, Zerion and others.
The company highlighted positive final investigational study results for its sublingual high-dose aspirin showing higher and faster mean plasma concentrations of ASA versus chewed aspirin, which the company says is relevant for potential treatment of suspected acute myocardial infarction. Aspire said discussions focused on technical collaboration, licensing, joint ventures and commercial partnerships to accelerate development and market readiness.
Aspire Biopharma (Nasdaq: ASBP) filed an omnibus patent application with the U.S. Patent and Trademark Office on October 6, 2025, seeking broad protection for its sublingual drug delivery platform.
The application targets multiple drug classes and aims to protect features that increase API bioavailability and speed of onset via rapid sublingual absorption, bypassing first-pass metabolism, reducing GI exposure and interactions, and improving ease of administration in emergency settings. Aspire says the omnibus filing complements patents already filed and expands its intellectual property coverage across new product areas.
Aspire Biopharma (NASDAQ:ASBP) announced that Interim CEO Kraig Higginson will present and hold 1x1 investor meetings at the Noble Capital Markets 2025 Emerging Growth Virtual Equity Conference on October 8-9, 2025.
The virtual presentation is scheduled for Wednesday, October 8 at 1:00 PM ET, with 1x1 meetings on October 8-9. Management will discuss pipeline progress and upcoming milestones, including a planned H2 2025 FDA meeting request and targeted NDA submission in H2 2025 for the lead sublingual high-dose aspirin program, and formulation completion and Phase 1 PK cross-over studies for sublingual semaglutide and a needle-free ED medication in H1–mid‑2026. For registration, investors are directed to the Noble conference site.
Aspire Biopharma (NASDAQ:ASBP) has outlined its milestone roadmap through 2026, focusing on its patent-pending sublingual drug delivery technology. The company's lead program targets an H2 2025 FDA submission for sublingual high-dose aspirin, following positive clinical results showing faster absorption and better bioavailability compared to traditional tablets.
The pipeline includes two additional key programs scheduled for H1 2026: a rapid-acting sublingual ED medication and a sublingual version of semaglutide for diabetes and weight management. Both programs will undergo Phase 1 pharmacokinetic studies in 2026. The company's strategy focuses on reformulating approved drugs for multi-billion-dollar markets, with plans to expand into CNS, men's health, and anti-nausea medications.