Belhaven Biopharma

Belhaven - Needle-Free Epinephrine Nasal Spray for Fast, Reliable Allergy Emergency Relief

Belhaven Biopharma begins a pivotal randomized crossover trial comparing its nasal powder epinephrine formulation (BBP01) against intramuscular auto-injectors and manual administration. The study evaluates pharmacokinetic and pharmacodynamic profiles in treating anaphylaxis. BBP01 aims to offer an alternative delivery method for emergency epinephrine treatment.

Oct 2026ACCESS NewswireNews article

Belhaven Biopharma expands its Nasdepi patent portfolio and prepares for commercial launch, aligning with FDA guidelines. The company readies its supply chain and plans to begin a pivotal clinical study in **Q3 2026**, marking a critical step toward regulatory approval and market introduction.

Jul 2026Yahoo FinanceNews article

Belhaven Biopharma begins a pivotal biocomparability study evaluating Nasdepi® against epinephrine intramuscular injections. The trial assesses pharmacokinetics, pharmacodynamics, and safety under an FDA-authorized Investigational New Drug (IND) application. Results may inform regulatory approval pathways for Nasdepi® as an alternative treatment.

Oct 2025BioSpaceNews article

Belhaven Biopharma secures an oversubscribed **Series A funding round** to accelerate development of its **Nasdepi® program**, now progressing into **late-stage clinical trials and manufacturing** toward a **New Drug Application (NDA) submission**. The capital infusion supports preparations for potential **commercial launch partnerships**. The company specializes in clinical-stage biopharmaceuticals.

Aug 2025Yahoo FinanceNews article