Phathom Pharmaceuticals Announces Publication of Data from Phase 3 pHalcon-NERD-301 Study Showing VOQUEZNA® (vonoprazan) Improved Nocturnal GERD Symptoms in Patients with Non-Erosive Reflux Disease

• Data published in the American Journal of Gastroenterology showed rapid and sustained relief of nighttime gastroesophageal reflux disease (GERD) symptoms in patients treated with VOQUEZNA, including clinically meaningful increases in heartburn-free nights observed after the first dose and maintained through 24 weeks of treatment
• Analysis of exploratory endpoints showed durable improvements in measures of nocturnal symptom severity and sleep-related impacts throughout the full treatment period

FLORHAM PARK, N.J., Oct. 25, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that results of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial evaluating VOQUEZNA® (vonoprazan) tablets in patients with Non-Erosive Reflux Disease (NERD) have been published in the American Journal of Gastroenterology. The article, titled “Vonoprazan Improves Nocturnal Gastroesophageal Reflux Symptoms in Non-Erosive Reflux Disease”, underscores the significant burden of nighttime GERD symptoms and the potential role of VOQUEZNA in addressing this aspect of the disease.

Nighttime GERD symptoms are highly prevalent, affecting up to an estimated 80% of patients with GERD, and can be associated with impaired sleep, reduced work productivity, and increased risk of esophageal and respiratory complications. Despite lifestyle interventions and the widespread use of proton pump inhibitors (PPIs) and H2-receptor antagonists (H2RAs), many patients experience inadequate relief of nocturnal symptoms, which remain underrepresented in clinical research.

“Nocturnal symptoms can be among the most disruptive and difficult-to-manage aspects of GERD,” said Philip Katz, MD, MACG, Professor of Medicine, Weill Cornell Medicine and study author who serves as a consultant for Phathom Pharmaceuticals. “This large, randomized trial provides important support for VOQUEZNA’s potential role in improving sleep and daily functioning for patients with Non-Erosive Reflux Disease.”

In the Phase 3 pHalcon-NERD-301 trial, 772 patients were randomized to VOQUEZNA 10 mg, 20 mg, or placebo for an initial 4-week period. Patients on VOQUEZNA continued blinded active treatment for a 20-week extension, while those on placebo were re-randomized to VOQUEZNA 10 mg or 20 mg for the extension phase.  

Key findings include:

• Percentage of Heartburn-Free Nights: At week 4, patients receiving VOQUEZNA 10 mg and 20 mg achieved mean percentages of heartburn-free nights of 59.9% and 56.4%, respectively, compared to 43.3% for placebo (nominal p