Aspire Biopharma says FDA feeback supports NDA filing in 2H26

Aspire Biopharma (ASBP) announced the outcome of a Type B pre-Investigational New Drug meeting with the U.S. Food and Drug Administration. The meeting provided a clear regulatory roadmap for the Company’s investigational new drug, acetylsalicylic acid 162 mg sublingual powder, designed for the emergency treatment of suspected acute myocardial infarction. 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 inhibition in 32 healthy volunteers, comparing OTASA 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. “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.”