Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Ondansetron (Generic Zofran(R))

Rhea-AI Summary

Aspire Biopharma (Nasdaq:ASBP) filed a provisional USPTO patent application on February 12, 2026 for a sublingual powder formulation of ondansetron, aimed at rapid relief of chemotherapy-, radiation- and surgery-induced nausea.

The company highlights potential near-instant absorption versus 30-minute oral tablets, plans to pursue an FDA 505(b)(2) pathway, and cites >12.5 million U.S. prescriptions and a ~$1.4B global market (2023).

Positive

• Provisional patent filed for sublingual ondansetron delivery
• Potential near-instant absorption vs 30-minute oral onset
• Planned 505(b)(2) pathway to leverage existing safety data

Negative

• Provisional application only; patent not yet issued
• Clinical comparability unproven; human trials required to confirm IV-like speed

News Market Reaction

-2.96%

11 alerts

-2.96% News Effect

+17.2% Peak Tracked

-5.5% Trough Tracked

-$158K Valuation Impact

$5M Market Cap

0.1x Rel. Volume

On the day this news was published, ASBP declined 2.96%, reflecting a moderate negative market reaction. Argus tracked a peak move of +17.2% during that session. Argus tracked a trough of -5.5% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $158K from the company's valuation, bringing the market cap to $5M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Ondansetron market 2023: $1.4 billion Ondansetron market 2032: $2.4 billion U.S. prescriptions 2023: 12.5 million prescriptions +2 more

5 metrics

Ondansetron market 2023 $1.4 billion Global ondansetron market size in 2023

Ondansetron market 2032 $2.4 billion Projected global ondansetron market by 2032

U.S. prescriptions 2023 12.5 million prescriptions Ondansetron prescriptions, 53rd most prescribed drug in U.S. 2023

Tablet onset delay 30 minutes Approximate onset delay for oral tablet ondansetron

FDA pathway 505(b)(2) Planned regulatory pathway to leverage existing safety data

Market Reality Check

Price: $1.43 Vol: Volume 9,633,955 is 5.85x...

high vol

$1.43 Last Close

Volume Volume 9,633,955 is 5.85x the 20-day average of 1,647,119, indicating elevated pre-news activity. high

Technical Shares at $1.35 are trading below the $11.37 200-day MA and sit 99.66% under the 52-week high.

Peers on Argus

ASBP is down 4.26% while peers show mixed moves: QTTB -9.04%, XCUR -3.3%, ICU -1...

ASBP is down 4.26% while peers show mixed moves: QTTB -9.04%, XCUR -3.3%, ICU -1.27%, NRXS -0.64%, and CRIS up 10.2%. With no peers in the momentum scanner and divergent directions, trading appears stock-specific rather than a coordinated sector move.

Historical Context

5 past events · Latest: Feb 11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 11	Private placement financing	Positive	-4.3%	Announced up to $21M private placement to strengthen balance sheet and equity.
Feb 10	Listing compliance update	Positive	-2.1%	Regained compliance with Nasdaq minimum bid price rule after sustained >$1.00 close.
Feb 05	Product marketing event	Positive	-14.8%	Subsidiary to showcase BUZZ BOMB sublingual caffeine at a nutrition summit.
Feb 03	Distribution partnership	Positive	-4.1%	Buzz Bomb signed distribution deal with Blue Shark to broaden SoCal reach.
Jan 29	Sublingual aspirin deal	Positive	-8.2%	Agreement with Microsize to develop 162 mg sublingual aspirin and plan 505(b)(2) NDA.

Pattern Detected

Over the past several announcements, ASBP shares have tended to trade lower even on operational or strategic updates that read positively, indicating a pattern of negative price reactions to ostensibly constructive news.

Recent Company History

In the last few weeks, Aspire Biopharma has focused on balance sheet repair, listing compliance, and advancing its sublingual platform. A $21.0 million private placement on Feb 11, 2026 followed news of regaining Nasdaq minimum bid compliance on Feb 10. Earlier, the company promoted its BUZZ BOMB™ sublingual caffeine and a distribution partnership, and on Jan 29, 2026 it secured an agreement for a 162 mg sublingual aspirin targeting a 505(b)(2) NDA. Each of these updates was followed by double- or mid-single-digit percentage declines, framing today’s patent-related news against a backdrop of persistent selling pressure.

Market Pulse Summary

This announcement adds a new provisional patent around a sublingual ondansetron powder targeting rap...

Analysis

This announcement adds a new provisional patent around a sublingual ondansetron powder targeting rapid relief in a $1.4 billion and growing market, projected to reach $2.4 billion by 2032. It reinforces Aspire’s focus on sublingual delivery, alongside recent work on sublingual aspirin and consumer caffeine products. Investors may monitor how effectively the company advances this candidate through the 505(b)(2) pathway, its ability to fund development following recent financings, and whether the platform gains clinical validation versus standard oral and IV formulations.

Key Terms

provisional patent application, united states patent and trademark office (uspto), sublingual, first-pass metabolism, +3 more

7 terms

provisional patent application regulatory

"today announced the filing of a provisional patent application with the United States"

A provisional patent application is a lightweight, temporary filing that records an inventor’s idea and sets an official filing date without starting the full patent review process. Think of it as placing a hold on an idea while you prepare the complete paperwork; it doesn’t grant a patent but can preserve the right to seek one later. For investors, it signals a company is protecting potential intellectual property, which can affect future competitive advantage and valuation, but it is not a guarantee of patent protection.

united states patent and trademark office (uspto) regulatory

"provisional patent application with the United States Patent and Trademark Office (USPTO)."

The United States Patent and Trademark Office (USPTO) is the federal agency that examines and grants patents and registers trademarks, giving creators official, time-limited rights to inventions and brand names. For investors, USPTO decisions matter because patents and trademarks can protect a company’s products and brand from copycats, support higher pricing or licensing revenue, and influence a company’s value and legal risk—think of it as an official lock and record that helps secure a business’s competitive edge.

sublingual medical

"A Sublingual Powder Formulation of Ondansetron and Methods of Use Thereof," marks the first-ever"

Sublingual describes a way to take a drug or supplement by placing it under the tongue so active ingredients are absorbed through the thin tissue there directly into the bloodstream. Like taking a shortcut compared with swallowing a pill, this can produce faster effects, simpler dosing and sometimes more predictable delivery. Investors watch for sublingual formulations because they can affect a product’s market appeal, regulatory pathway, pricing and competitive positioning.

first-pass metabolism medical

"Bypasses the gastrointestinal tract and first-pass metabolism, potentially reducing onset of"

First-pass metabolism is the process by which a drug taken by mouth is partly broken down in the gut wall and liver before it reaches the bloodstream, so less active medicine is available to the body. For investors, it matters because a high first-pass effect can force higher doses, different formulations or alternative delivery methods, increasing development cost, regulatory complexity and the commercial attractiveness of a drug—think of it as a filter that removes part of the product before it reaches customers.

intravenous (iv) medical

"Designed to mirror the speed of intravenous (IV) administration without the need for"

A method of delivering fluids, medicines or nutrients directly into a vein through a needle or tube so they enter the bloodstream immediately, like sending a package straight to the main highway instead of along side roads. Investors care because intravenous delivery affects how fast and reliably a treatment works, the complexity and cost of products and devices, hospital and clinic use, regulatory scrutiny and reimbursement — all of which influence commercial value.

emesis medical

"patients who cannot swallow tablets due to severe emesis (vomiting) or gastric irritation."

Emesis is the medical term for vomiting — the forceful expulsion of stomach contents through the mouth. For investors, how often and how severe emesis occurs with a treatment is important because it affects patient comfort, adherence to therapy, regulatory review and market uptake; like a product defect that drives customers away or adds extra costs to manage, high rates of emesis can reduce a therapy’s commercial value.

505(b)(2) regulatory pathway regulatory

"Aspire intends to utilize the FDA's 505(b)(2) regulatory pathway, which leverages existing"

A 505(b)(2) regulatory pathway is a U.S. drug approval route that allows a company to use some existing safety and effectiveness data from earlier studies or other approved products instead of repeating every test. It speeds development and cuts costs compared with a full new-drug filing while still requiring new data for any changes. For investors, it can shorten time to market and reduce development risk—think of renovating a house using an existing foundation rather than building from scratch.

AI-generated analysis. Not financial advice.

New sublingual delivery system designed to provide more rapid relief from nausea caused by cancer medicines

Ondansetron, currently sold under the brand name Zofran^®, was the 53rd most commonly prescribed medication in the U.S. in 2023

Global ondansetron market size valued at approximately $1.4 billion in 2023

ESTERO, FL / ACCESS Newswire / February 12, 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 filing of a provisional patent application with the United States Patent and Trademark Office (USPTO). The application, titled "A Sublingual Powder Formulation of Ondansetron and Methods of Use Thereof," marks the first-ever sublingual powder delivery system for ondansetron-the active ingredient in Zofran^®. Aspire's formulation is designed to provide rapid relief for patients suffering from nausea and vomiting induced by chemotherapy, radiation, or surgery.

Redefining Nausea Relief: IV Speed Without the Needle

Ondansetron is currently limited by a roughly 30-minute delay when taken as a tablet. NIH

Aspire's sublingual platform is engineered to deliver:

• Near-Instant Absorption: Bypasses the gastrointestinal tract and first-pass metabolism, potentially reducing onset of action from 30 minutes to just minutes.

• Clinical Comparability: Designed to mirror the speed of intravenous (IV) administration without the need for hospital-based injections or professional assistance.

• Patient Compliance: Specifically addresses the "unmet need" for patients who cannot swallow tablets due to severe emesis (vomiting) or gastric irritation.

Strategic Market Positioning

• Significant and Growing Utilization: Ondansetron was the 53rd most prescribed medication in the U.S. in 2023, with over 12.5 million prescriptions, according to ClinCalc.

• Market Growth: The global ondansetron market is projected to grow from $1.4 billion (2023) to $2.4 billion by 2032, driven by rising cancer incidences and expanded surgical procedures, according to DATAINTELO.

• Accelerated Approval Path: Aspire intends to utilize the FDA's 505(b)(2) regulatory pathway, which leverages existing safety data to streamline clinical development and reduce time-to-market.

CEO Commentary

"This product candidate exemplifies the real-world clinical benefits of our sublingual drug delivery technology, providing fast relief when minutes matter most. By making existing, trusted medications work better and faster, we aim to provide a treatment solution for anyone facing the debilitating effects of acute nausea-from chemotherapy side effects to post-operative recovery," said Kraig Higginson, Interim CEO of Aspire.

About Zofran^® and Ondansetron
Zofran^®, developed by GlaxoSmithKline, was approved by the FDA in 1991, with a generic version approved in July 2007. Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation therapy. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Aspire Biopharma Holdings, Inc.

Contact

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

SOURCE: Aspire Biopharma Holdings, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Aspire Biopharma (ASBP) announce on February 12, 2026?

Aspire filed a provisional USPTO patent application for a sublingual ondansetron powder on February 12, 2026. According to the company, the formulation targets rapid relief for chemotherapy-, radiation- and surgery-induced nausea and represents the first sublingual powder delivery for ondansetron.

How fast does Aspire claim its sublingual ondansetron (ASBP) works compared with tablets?

Aspire claims onset could drop from ~30 minutes to just minutes with the sublingual powder. According to the company, the sublingual route bypasses first-pass metabolism and may mirror intravenous administration speed without injections.

What regulatory route will Aspire (ASBP) pursue for the sublingual ondansetron candidate?

Aspire intends to use the FDA 505(b)(2) pathway to streamline development and rely on existing safety data. According to the company, this approach aims to reduce time-to-market versus a full NDA program.

What market opportunity did Aspire cite for ondansetron in the announcement?

Aspire cited over 12.5 million U.S. prescriptions and a global ondansetron market valued at about $1.4 billion in 2023. According to the company, growth drivers include rising cancer incidence and expanded surgical procedures.

What does the provisional patent filing mean for ASBP shareholders?

A provisional filing secures an early priority date but does not grant patent rights yet. According to the company, it starts intellectual property protection while further development and formal patent prosecution continue.