Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin (OTASA) [Yahoo! Finance]
Aspire Biopharma Holdings, Inc. (ASBP)
Company Research
Source: Yahoo! Finance
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 B (TxB ) inhibition in 32 healthy vol
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ASBP
Sec Filings
- 1/15/26 - Form 8-K
- 1/13/26 - Form 8-K
- 12/15/25 - Form EFFECT
- ASBP's page on the SEC website