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

Rhea-AI Summary

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.

Positive

• FDA pre-IND clearance supporting 505(b)(2) pathway
• Planned 505(b)(2) NDA filing in H2 2026
• 32-subject multicenter crossover trial planned
• Pilot data: TxB2 inhibition within 2 minutes
• Pilot data: no reported adverse events

Negative

• Planned pivotal study limited to 32 healthy volunteers
• No clinical efficacy data in actual myocardial infarction patients reported

Key Figures

Planned trial size 32 subjects Multicenter crossover trial for OTASA TxB2 inhibition

OTASA dose 162 mg Sublingual acetylsalicylic acid for suspected heart attack

Comparator dose Two 81 mg tablets Current standard of care chewed aspirin comparator

Onset of TxB2 inhibition Within 2 minutes Time to biomarker inhibition in pilot proof-of-concept trial

Planned NDA timing H2 2026 Targeted 505(b)(2) New Drug Application submission for OTASA

Q3 2025 net loss $1,850,493 Quarter ended September 30, 2025

Q3 2025 cash $1,948,271 Cash balance as of September 30, 2025

Equity line capacity $100,000,000 Maximum common stock sale to Arena under ELOC agreement

Market Reality Check

$0.1256 Last Close

Volume Volume 20,977,052 vs 18,577,033 20-day average (about 1.13x), indicating slightly elevated trading activity ahead of this FDA update. normal

Technical Price at $0.105 is trading below the $0.35 200-day moving average, reflecting a longer-term downtrend and significant drawdown from the 52-week high of $9.86.

Peers on Argus

While ASBP traded down 12.65%, key biotech peers like XCUR, ICU, and NRXS showed modest gains between 0.6% and 2.43%, suggesting today’s weakness is stock-specific rather than part of a broader sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 18	Marketing partnership	Positive	+4.6%	Endurance athlete named BUZZ BOMB brand ambassador to boost product visibility.
Dec 12	Nasdaq compliance	Negative	-9.1%	Nasdaq panel granted time-limited extension to regain listing compliance.
Dec 04	Business update	Positive	+2.5%	Q3 update with fast platelet inhibition data and positive FDA pre-IND feedback.
Dec 02	Regulatory submission	Positive	+1.1%	Pre-IND meeting request submitted for fast-acting sublingual aspirin AMI therapy.
Nov 26	Key hire	Positive	+2.8%	Addition of experienced scientific leader to advance sublingual delivery platform.

Pattern Detected

Recent news flow shows modest positive price reactions to operational and clinical updates, while regulatory/listing-related developments have coincided with negative moves.

Recent Company History

Over the past months, Aspire Biopharma has focused on building its sublingual drug-delivery franchise and stabilizing its listing status. On Nov 26, 2025, the hire of Dr. Jaroszeski supported platform development. Subsequent pre-IND and Q3 updates across Dec 2–4, 2025 highlighted fast-acting sublingual aspirin data and regulatory progress, each followed by small positive moves. In contrast, the Dec 12, 2025 Nasdaq extension notice saw a -9.09% reaction, underscoring sensitivity to compliance and capital-structure concerns. The current FDA pre-IND outcome fits the ongoing regulatory progression of the aspirin program.

Market Pulse Summary

The stock surged +19.6% in the session following this news. A strong positive reaction would align with prior patterns where Aspire’s stock moved higher on clinical and regulatory milestones, such as the pre-IND submission and Q3 update. The FDA’s supportive Type B pre-IND feedback and no requirement for additional studies beyond a 32-subject trial provide clearer visibility for the OTASA aspirin program. However, past filings highlighted limited cash of $1,948,271 and ongoing losses, which could still influence longer-term sustainability.

Key Terms

type b pre-investigational new drug (ind) meeting regulatory

"announced the successful outcome of a Type B pre-Investigational New Drug (IND) meeting"

A Type B pre‑Investigational New Drug (pre‑IND) meeting is a scheduled discussion between a drug developer and a regulatory authority (for example, the U.S. Food and Drug Administration) held before human trials begin to review planned studies, safety checks, and data needs. For investors, it matters because a constructive meeting can reduce uncertainty about what evidence regulators will require, clarify timelines and costs, and lower the risk that costly changes will be needed later—think of it as getting a building permit check before construction starts.

investigational new drug (ind) regulatory

"Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

acute myocardial infarction medical

"designed for the emergency treatment of suspected acute myocardial infarction (heart attack)"

Acute myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked, causing heart muscle to be damaged or die; think of it as a plumbing clog that starves part of the heart of oxygen. Investors care because such events drive demand for emergency treatment, long‑term medications, medical devices and hospital services, affect healthcare costs and reimbursement patterns, and can influence the financial outlook and regulatory scrutiny of companies in pharmaceuticals, medical devices and health services.

505(b)(2) regulatory

"submitting a Section 505(b)(2) New Drug Application"

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

new drug application regulatory

"then submitting a Section 505(b)(2) New Drug Application"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

serum thromboxane b2 (txb2) medical

"The clinical trial will evaluate serum thromboxane B2 (TxB2) inhibition in 32 healthy volunteers"

Serum thromboxane B2 (TXB2) is a stable chemical in the blood that reflects how active platelets are in forming clots; it is the measurable leftover of a short-lived molecule that directly makes platelets stick together. Investors care because TXB2 levels are used in clinical studies to show whether blood-thinning or cardiovascular drugs are working or causing excess bleeding risk—think of it as a thermometer that helps gauge a drug’s effect on clotting.

breakthrough therapy status regulatory

"leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product"

A regulatory designation granted when early clinical evidence suggests a new drug or treatment may offer substantial improvement over existing options for a serious condition. It matters to investors because it can speed development and regulatory review, provide more frequent interaction with regulators, and increase the likelihood of faster market access—think of it as a “fast pass” through parts of the approval process that can reduce time, cost, and uncertainty, though it does not guarantee approval.

AI-generated analysis. Not financial advice.

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial

ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a biopharmaceutical company developing multi-faceted patent-pending drug delivery technology, today announced the successful outcome of a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA). The meeting provided a clear regulatory roadmap for the Company's investigational new drug, acetylsalicylic acid 162 mg sublingual powder (OTASA), designed for the emergency treatment of suspected acute myocardial infarction (heart attack).

The FDA's written responses provide the necessary guidance to finalize the Company's clinical and regulatory development strategy. Based on FDA's feedback, Aspire anticipates completing a currently planned multicenter crossover clinical trial and then submitting a Section 505(b)(2) New Drug Application. The clinical trial will evaluate serum thromboxane B₂ (TxB₂) inhibition in 32 healthy volunteers, comparing OTASA (162 mg) against the current standard of care-two chewed 81 mg aspirin tablets.

"The FDA's constructive feedback validates our development path and brings us one step closer to providing a faster-acting intervention for heart attack patients," said Kraig Higginson, Interim CEO of Aspire. "Aligning with the Agency on our clinical requirements significantly de-risks our timeline and we believe the FDA's response leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product. We believe OTASA has the potential to become the market-leading emergency treatment, and this regulatory clarity is a vital milestone as we engage in active discussions with potential commercial partners."

Clinical Data Highlights
The pre-IND submission was supported by data from a pilot, proof-of-concept clinical trial demonstrating:

• Rapid Absorption: OTASA produced higher and faster mean plasma concentrations of acetylsalicylic acid (ASA) compared to chewed aspirin tablets.

• Rapid Platelet Inhibition: The sublingual formulation inhibited serum TxB₂-a key biomarker for platelet aggregation-within the first two minutes of administration.

• Safety Profile: In initial evaluations, the product was safe and well-tolerated, with no reported adverse events.

About Aspire Biopharma Holdings, Inc.

Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs to the body rapidly and precisely. This technology offers the potential to improve effectiveness and reduce side effects by going directly to the bloodstream and avoiding the gastrointestinal tract. Aspire Biopharma's delivery technology can be applied to many different active pharmaceutical ingredients (APIs) and other bioactive substances, spanning both small and large molecule therapeutics, nutraceuticals and supplements.

For more information, please visit www.aspirebiolabs.com

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Aspire's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and

developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; Aspire's acetylsalicylic acid sublingual powder, 162 mg (OTASA) is an investigational new drug and has not been approved for marketing for any indication, our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; that the Company will be able to meet the deadlines or conditions imposed by the Hearings Panel or regain compliance with all applicable requirements for continued listing, and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

Aspire Biopharma Holdings, Inc.

Contact:

PCG Advisory
Kevin McGrath
+1-646-418-7002
kevin@pcgadvisory.com

SOURCE: Aspire Biopharma Holdings, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Aspire Biopharma (ASBP) announce on January 7, 2026?

Aspire announced a successful Type B pre-IND meeting with the FDA and feedback supporting a 505(b)(2) NDA filing in H2 2026 after a planned trial.

What is the design and size of the OTASA clinical trial for ASBP?

A multicenter crossover clinical trial in 32 healthy volunteers comparing OTASA 162 mg sublingual powder to two chewed 81 mg aspirin tablets, measuring serum TxB2.

What clinical results supported Aspire's pre-IND submission for ASBP OTASA?

Pilot data showed faster ASA plasma concentrations, TxB2 inhibition within two minutes, and no reported adverse events.

When does ASBP expect to submit the 505(b)(2) NDA for OTASA?

The company anticipates submitting a Section 505(b)(2) NDA in H2 2026 following completion of the planned clinical trial.

Does the FDA require additional studies beyond the planned 32-subject trial for ASBP?

According to the FDA feedback, no additional studies beyond the currently planned 32-subject trial were required for the proposed 505(b)(2) pathway.

Has OTASA been shown effective in heart attack patients per ASBP's announcement?

No; the reported clinical data are from a pilot study and a planned healthy-volunteer trial measuring biomarker TxB2, not outcomes in myocardial infarction patients.