Phathom Pharmaceuticals Initiates Phase 3 Screening for VOQUEZNA in NERD

What Happened
On September 29, 2026, Phathom Pharmaceuticals (PHAT) announced the start of patient screening for pHalcon‑NERD‑302, a registrational Phase 3 study evaluating an as‑needed (PRN) dosing regimen of VOQUEZNA (vonoprazan) 10 mg tablets in adults with Non‑Erosive Gastroesophageal Reflux Disease (NERD). The company said topline results are expected in the first quarter of 2028. The study follows previously reported positive Phase 2 results and is intended to support a potential regulatory submission for a label expansion if successful.

Key Details

• Study name: pHalcon‑NERD‑302; announced screening start date: Sept 29, 2026.
• Planned enrollment: ~500 adults with NERD who report heartburn ≥4 days/week; ~80 U.S. sites.
• Design: 4‑week open‑label run‑in with VOQUEZNA 10 mg once daily; patients without heartburn in final 7 days randomized 1:1 to VOQUEZNA 10 mg PRN or placebo for 24 weeks.
• Primary endpoint: at Week 12 — percent of heartburn episodes with complete relief within 2 hours and sustained relief for 24 hours. Topline results expected Q1 2028.

Why It Matters
A positive, registrational Phase 3 result could enable Phathom to pursue a label expansion for VOQUEZNA as an on‑demand treatment option for NERD, potentially expanding the drug’s market use beyond current indications. The filing also highlights timing and execution risks (enrollment, site activation, study conduct) and includes forward‑looking statement cautions; investors should monitor enrollment progress and the Q1 2028 topline milestone.