Thursday, 16 July 2026 09:15 AM
Company Update
Pivotal Clinical Study Poised to Start in Q3 2026
RALEIGH, NC / ACCESS Newswire / July 16, 2026 / Belhaven Biopharma today issued a corporate update announcing key milestones that together materially advance the company's path to commercialization and partnership for Nasdepi®, its dry‑powder nasal epinephrine product.
The company secured additional US patents to further strengthen Nasdepi's patent portfolio.
The company established commercial‑scale manufacturing capacity to support initial global market forecasts and reduce launch risk.
Ongoing discussions with the U.S. Food and Drug Administration (FDA) have resulted in clarity of the overall clinical development plan, the summative human factors study, and the device reliability plan needed for approval.
Belhaven now holds 11 issued U.S. patents, with an additional 10 patents pending. The expanded patent estate provides broad coverage for dry‑powder nasal epinephrine products, encompassing formulation, methods of use, and pharmacologic outcomes. The company's patent portfolio is the largest in the dry‑powder nasal epinephrine space and creates a durable competitive position. Belhaven now intends to pursue corresponding patent protections globally.
At the same time, Belhaven has produced Nasdepi at commercial‑scale utilizing an integrated manufacturing strategy with highly reputable contract manufacturing partners. Initial annual capacity is in the range of 2-3 million devices, aligned with near‑term market projections and scalable to meet the needs of the prescribed U.S. anaphylaxis epinephrine autoinjector market of approximately $3.5 billion, which represents approximately half of the total diagnosed patients.
Belhaven also continues proactive engagement with the FDA on key development topics, including the overall clinical development program, emergency use reliability testing, and the summative human factors study design. The company expects to begin its pivotal clinical study in Q3 2026.
"These milestones reflect deliberate, tangible progress," said Scott Lyman, CEO of Belhaven Biopharma. "We have spent the past few months strengthening the foundation of our company: expanding IP coverage while implementing a commercial-scale manufacturing process for producing Nasdepi. Combined with ongoing dialog and feedback from the FDA on all aspects of the Nasdepi program, these advances solidify market positioning and reduce execution risk for potential commercial partners."
Belhaven is focused on strategic pharmaceutical partnerships to maximize patient access and commercialization reach worldwide. Commercial manufacturing readiness validates the product can launch once regulatory approvals are obtained and supports partner pre-launch and long-term commercial execution.
For more information, please visit:www.belhavenbio.com
About Belhaven Biopharma
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