RALEIGH, NC / ACCESS Newswire / October 6, 2026 / Belhaven Biopharma, Inc. today announced the initiation of a pivotal clinical study evaluating BBP01, an investigational nasal powder formulation of epinephrine being developed as a needle-free alternative for the delivery of epinephrine to treat anaphylaxis.

The randomized, open-label, three-treatment crossover study design will assess the comparative bioavailability of an intranasal dose of BBP01 against two established intramuscular reference products: a 0.3 mg epinephrine auto-injector and a 0.3 mg manual intramuscular injection of Adrenalin® in 60 adult participants. Secondary endpoints will assess the safety and tolerability of BBP01, including nasal examinations, and pharmacodynamic changes in blood pressure, heart rate and mean arterial pressure.

"This study will generate the definitive data we need to conduct our pre-NDA meeting with FDA in 1Q27," said Scott Lyman, CEO of Belhaven Biopharma. "Confirming FDA alignment with our previous interactions on the work completed in the clinic, human factors, and manufacturing validates that we move into completing the remaining supportive work needed for filing our NDA in 2027."

BBP01 is an investigational product and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Its safety and efficacy have not been established.

For more information, please visit: www.belhavenbio.com

About Belhaven Biopharma, Inc.

Belhaven Biopharma is a clinical-stage pharmaceutical research company specializing in developing life-saving medications delivered quickly, effectively, and painlessly with a simple, dry powder, single-use nasal device. They are at the forefront of developing nasal dry powder epinephrine, which is revolutionizing emergency-use epinephrine delivery and expanding global access. Nasdepi^®, Belhaven's lead program, is the first dry powder nasal device for treating life-threatening allergic reactions.

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SOURCE: Belhaven Biopharma