Microsize brings over thirty years of expertise in specialized particle size engineering for the pharmaceutical industry, from pre-clinical development to full-scale GMP commercial manufacturing.
ESTERO, FLORIDA / ACCESS Newswire / January 29, 2026 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a biopharmaceutical company developing multi-faceted, patent-pending drug delivery technology, today announced it has entered into an agreement with Microsize (Quakertown, Pennsylvania), the largest independent North American contract development and manufacturing organization (CDMO) focused on cGMP micronization and particle size engineering.
Microsize specializes in particle size reduction, micronization, and solubility enhancement for drugs. Aspire has partnered with Microsize to support the ongoing development of its lead drug candidate: acetylsalicylic acid (aspirin) 162 mg sublingual powder, an investigational new drug undergoing development for the emergency treatment of suspected acute myocardial infarction (heart attack).
This collaboration is expected to deliver optimized drug product to support an upcoming clinical trial and the planned submission of a Section 505(b)(2) New Drug Application for Aspire's sublingual aspirin near the end of 2026.
The clinical trial will evaluate serum thromboxane B2 (TxB2) inhibition in 32 healthy volunteers, comparing (162 mg) against the current standard of care-two chewed 81 mg aspirin tablets. This collaboration marks a critical step for Aspire, securing critical expertise to support its ongoing and future product development and regulatory efforts.
CEO Commentary
"We value Microsize's special expertise and are excited to partner with the Microsize team to support development of our sublingual aspirin product as we prepare to submit a New Drug Application later this year," said Kraig Higginson, Interim CEO of Aspire. "This agreement is a critical step in our path forward, and reinforces our commitment to excellence, product quality, and U.S.-based innovation."
This agreement builds upon Aspire's broader strategy to develop existing, approved therapeutics that offer faster onset of action with fewer side effects.
About Microsize
For over 30 years, Microsize has been a pioneer in enhancing dissolution and bioavailabilty of Active Pharmaceutical Ingredients (API's) and functional excipients via particle size reduction technologies including milling, micronization and classification. Operating from 100,000 square feet in US-based, state-of-the-art, FDA inspected GMP facilities, Microsize has the experience and capabilities to rapidly develop, scale up, and process API's and excipients ranging from grams to multi-metric tons, including highly potent compounds. Microsize is the partner of choice from small biotechs to big pharma to CDMO's, and is recognized for its speed, responsiveness, and high customer-touch business model. Visit www.microsize.com.
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 small 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 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.
SOURCE: Aspire Biopharma Holdings, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/aspire-biopharma-secures-agreement-with-microsize-for-development-of-1131388
