Shares of Aspire Biopharma Holdings Inc (NASDAQ:ASBP) jumped more than 60% in premarket trading on Wednesday after the company said a pre-IND meeting with the Food and Drug Administration had produced positive feedback for its emergency heart attack treatment.
Aspire said the FDA endorsed its proposed regulatory approach for OTASA, a sublingual aspirin powder intended for use in suspected heart attack cases. According to the company, the agency indicated that no additional studies beyond Aspire’s planned 32-participant clinical trial would be required ahead of a potential 505(b)(2) regulatory filing, which the company is targeting for the second half of 2026.
The upcoming study will compare OTASA at a 162 mg dose with the current standard of care — two chewed 81 mg aspirin tablets — by assessing inhibition of serum thromboxane B2 levels in healthy volunteers.
Commenting on the outcome of the meeting, Interim Chief Executive Officer Kraig Higginson said: “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.”
Aspire added that its submission to the FDA included results from a pilot clinical trial showing that OTASA achieved higher and more rapid average plasma concentrations of acetylsalicylic acid compared with chewed aspirin tablets. The company said the sublingual formulation also delivered rapid platelet inhibition within two minutes of dosing.
The company noted that the FDA’s response could support a future application for breakthrough therapy designation for OTASA. Aspire also said it is currently in discussions with potential commercial partners as it advances development of the product.