Phathom Pharmaceuticals (NASDAQ: PHAT) reported publication of Phase 3 pHalcon-NERD-301 data in the American Journal of Gastroenterology showing VOQUEZNA (vonoprazan) produced rapid and sustained relief of nocturnal GERD symptoms.
In 772 randomized patients, mean heartburn-free nights at Week 4 were 59.9% (10 mg) and 56.4% (20 mg) vs 43.3% for placebo (nominal p70% through the 20-week extension. VOQUEZNA improved N-GSSIQ scores for nocturnal severity and concern and was generally well tolerated with common AEs ≤5% in the extension.
Phathom Pharmaceuticals (NASDAQ: PHAT) ha riportato la pubblicazione dei dati di fase 3 pHalcon-NERD-301 sull’American Journal of Gastroenterology che mostrano che VOQUEZNA (vonoprazan) ha prodotto un rapido e duraturo sollievo dai sintomi notturni della GERD.
In 772 pazienti randomizzati, le notti prive di bruciore a Week 4 sono state 59.9% (10 mg) e 56.4% (20 mg) rispetto al 43.3% per placebo (nominal p70% fino all’estensione di 20 settimane. VOQUEZNA ha migliorato i punteggi N-GSSIQ per severità notturna e preoccupazione ed è stato generalmente ben tollerato con eventi avversi comuni ≤5% nell’estensione.
Phathom Pharmaceuticals (NASDAQ: PHAT) informó la publicación de los datos de fase 3 pHalcon-NERD-301 en American Journal of Gastroenterology, que muestran que VOQUEZNA (vonoprazan) proporcionó un alivio rápido y sostenido de los síntomas nocturnos de GERD.
En 772 pacientes aleatorizados, las noches libres de ardor en la Semana 4 fueron 59.9% (10 mg) y 56.4% (20 mg) frente al 43.3% de placebo (p nominal 70% a lo largo de la extensión de 20 semanas. VOQUEZNA mejoró las puntuaciones N-GSSIQ de severidad nocturna y preocupación y, en general, se toleró bien con efectos adversos comunes ≤5% en la extensión.
Phathom Pharmaceuticals (NASDAQ: PHAT)은 VOQUEZNA(vonoprazan)가 야간 GERD 증상의 빠르고 지속적인 완화를 보여준 Phase 3 pHalcon-NERD-301 데이터가 American Journal of Gastroenterology에 발표되었다고 보고했습니다.
7772명의 무작위 배정 환자 중 4주 차의 속쓰림 없는 야간 수의 평균은 59.9% (10 mg) 및 56.4% (20 mg)로 위약의 43.3%에 비해 통계적으로 유의미했습니다(nominal p70%를 넘었습니다. VOQUEZNA는 야간 중증도 및 우려에 대한 N-GSSIQ 점수를 개선했고, 확장 기간 동안 일반적으로 잘 견뎌졌으며 확장 기간의 일반적 부작용은 ≤5%였습니다.
Phathom Pharmaceuticals (NASDAQ: PHAT) a annoncé la publication des données de phase 3 pHalcon-NERD-301 dans l’American Journal of Gastroenterology, montrant que VOQUEZNA (vonoprazan) a produit un soulagement rapide et durable des symptômes nocturnes de RGE.
Sur 772 patients randomisés, les nuits sans brûlure à la semaine 4 étaient 59,9% (10 mg) et 56,4% (20 mg) contre 43,3% placebo (p nominal 70% jusqu’à l’extension de 20 semaines. VOQUEZNA a amélioré les scores N-GSSIQ pour la gravité nocturne et l’inquiétude et a été généralement bien toléré, avec des EAs courants ≤5% dans l’extension.
Phathom Pharmaceuticals (NASDAQ: PHAT) berichtete die Veröffentlichung der Phase-3-Daten pHalcon-NERD-301 im American Journal of Gastroenterology, die zeigen, dass VOQUEZNA (vonoprazan) eine schnelle und anhaltende Linderung der nächtlichen GERD-Symptome bewirkte.
Bei 772 randomisierten Patienten lagen die nächtlichen Stunden frei von Sodbrennen in Woche 4 bei 59.9% (10 mg) und 56.4% (20 mg) gegenüber 43.3% Placebo (nominal p70% während der 20-wöchigen Verlängerung. VOQUEZNA verbesserte die N-GSSIQ-Werte für nächtliche Schweregrad und Sorge und wurde im Allgemeinen gut vertragen, wobei häufige unerwünschte Ereignisse ≤5% in der Verlängerung lagen.
Phathom Pharmaceuticals (NASDAQ: PHAT) أفادت بنشر بيانات المرحلة 3 pHalcon-NERD-301 في المجلة الأمريكية لعلم أمراض الجهاز الهضمي، مع عرض أن VOQUEZNA (vonoprazan) أظهر تخفيفاً سريعاً ومستداماً لأعراض GERD الليلية.
في 772 مريضاً عشوائياً، كانت ليالٍ خالية من حموضة عند الأسبوع 4 بمعدل 59.9% (10 ملغ) و 56.4% (20 ملغ) مقابل 43.3% في الدواء الوهمي (قيمة p nominal70% حتى التمديد البالغ 20 أسبوعاً. حسَّن VOQUEZNA درجات N-GSSIQ لحدة الليل والقلق، وكانت بشكل عام جيدة التحمل مع حدوث أحداث جانبية شائعة ≤5% في التمديد.
Phathom Pharmaceuticals (NASDAQ: PHAT) 已在《美国胃肠病学杂志》发表了阶段3研究 pHalcon-NERD-301 的数据，显示 VOQUEZNA（vonoprazan）可快速且持续缓解夜间GERD症状。
在772名随机分组患者中，第4周无烧心的夜晚平均为 59.9%（10 mg）和 56.4%（20 mg），对比安慰剂的 43.3%（名义值 p70%。VOQUEZNA改善了夜间严重程度与担忧的N-GSSIQ评分，总体耐受性良好，扩展期常见不良事件≤5%。
Positive
- 772 patients randomized in pivotal Phase 3 pHalcon-NERD-301
- Week 4 mean heartburn-free nights: 59.9% (10 mg) and 56.4% (20 mg) vs 43.3% placebo
- Onset after first dose: 45.3% (10 mg) and 52.4% (20 mg) had a heartburn-free night vs 32.1% placebo
- Median heartburn-free nights remained >70% through 20-week extension
- Sustained improvements on N-GSSIQ nocturnal severity and concern subscales through 24 weeks
Negative
- Key efficacy analyses described as exploratory and not adjusted for multiple comparisons
- Common adverse events reported up to 5% in the 20-week extension (eg, upper respiratory infection, sinusitis, nausea)
- Safety label includes multiple postmarketing risks (eg, TIN, SCAR, fundic gland polyps) requiring monitoring
Insights
Phase 3 data show rapid, sustained nighttime symptom relief with VOQUEZNA, supporting its clinical value in NERD.
VOQUEZNA produced clinically meaningful increases in heartburn-free nights versus placebo (mean 59.9% and 56.4% for 10 mg and 20 mg at week 4 versus 43.3% for placebo) with separation after the first dose and median heartburn-free nights above 70% through the extension. This pattern suggests a consistent symptomatic benefit for nocturnal GERD when prescribed as in the trial, and tolerability signals reported were mostly common, non-severe events observed at low frequencies.
Key dependencies and risks are clear in the data: the primary evidence is symptom-based and some analyses are described as exploratory and not adjusted for multiplicity, which limits certainty about statistical robustness. Safety observations (including postmarketing warnings listed in the prescribing information) require attention for long-term use. Watch for additional peer-reviewed analyses, regulatory labeling language and real-world tolerability data over a 24 weeks to one year horizon; pay particular attention to confirmatory endpoints, multiplicity-adjusted statistical results, and any emerging safety signals in broader practice.
10/25/2025 – 09:59 AM
- 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. – Phathom Pharmaceuticals (NASDAQ: PHAT) shares are edging higher this morning following the release of data showcasing the efficacy of VOQUEZNA (vonoprazan) in treating nocturnal GERD. The findings, published in the *American Journal of Gastroenterology,* bolster the drug’s profile in addressing a significant and often undertreated aspect of GERD.
The Phase 3 pHalcon-NERD-301 trial, a randomized, double-blind, placebo-controlled study, evaluated VOQUEZNA in patients with Non-Erosive Reflux Disease (NERD). The study enrolled 772 patients, with results indicating that VOQUEZNA not only provided rapid relief but also sustained relief of nighttime GERD symptoms. Specifically, patients receiving VOQUEZNA experienced a statistically significant increase in heartburn-free nights compared to those on placebo. At Week 4, nearly 60% of patients on the 10mg dose and 56.4% on the 20mg dose reported heartburn-free nights, compared to just 43.3% in the placebo group.
“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. “This data confirms VOQUEZNA’s potential role in improving sleep and daily functioning for patients with NERD, particularly targeting those persistent nighttime symptoms.”
The trial also highlighted the speed of onset, with a clear separation from placebo observed after the very first dose. Approximately 45.3% and 52.4% of patients taking the 10 mg and 20 mg doses, respectively, experienced a heartburn-free night after the first dose, compared to 32.1% in the placebo group. This rapid action could be a significant advantage for patients seeking immediate relief.
VOQUEZNA’s sustained efficacy was further demonstrated through a 20-week extension, with median heartburn-free nights remaining above 70% across all treatment groups. Moreover, patient-reported outcomes, measured by the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ), showed improvements from baseline versus placebo in total N-GSSIQ score, and in the subscales of nocturnal symptom severity and concern about nocturnal GERD, but not on morning impact.
From a safety perspective, VOQUEZNA was generally well-tolerated. The most common adverse events reported during the 4-week initial period were nausea, abdominal pain, constipation, diarrhea, and urinary tract infection. The 20-week extension saw similarly low occurrences of adverse events. However, the label includes postmarketing risks, such as acute tubulointerstitial nephritis, severe cutaneous adverse reactions, and fundic gland polyps, requiring ongoing monitoring and vigilance. Also to note, key efficacy analyses are explaratory and not adjusted for multiple comparisons.
According to Phathom Pharmaceuticals, an estimated 38 million adults in the U.S. live with Non-Erosive GERD, underscoring the potential market opportunity for VOQUEZNA. As a potassium-competitive acid blocker (PCAB), VOQUEZNA represents a novel approach to acid suppression, potentially offering advantages over traditional proton pump inhibitors (PPIs).
Analysts will be closely watching Phathom’s upcoming earnings calls and presentations for further insights into the commercial ramp-up and market penetration strategy for VOQUEZNA, particularly in the context of evolving treatment guidelines and competitive dynamics within the GERD market.
VOQUEZNA: Key Considerations for Investors
- Market Opportunity: Assess the potential revenue growth from addressing the unmet needs of NERD patients, particularly those experiencing nocturnal GERD and seeking superior acid suppression.
- Clinical Data: Analyze the statistical significance of key efficacy endpoints, considering that some are exploratory and not adjusted for multiple comparisons. Evaluate the durability of VOQUEZNA’s benefits and the impact on patient-reported outcomes.
- Competitive Landscape: Understand how VOQUEZNA differentiates itself from existing therapies, including PPIs and H2RAs. Track pricing strategies and market access initiatives to gauge its competitive edge.
- Safety Profile: Monitor real-world tolerability data and ensure awareness of potential adverse events. Assess the impact of safety labeling on prescribing patterns and market adoption.
Phathom currently markets vonoprazan in the United States as VOQUEZNA for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for the treatment of *H. pylori* infection in adults.
FAQ
What did Phathom (PHAT) publish on October 25, 2025 about VOQUEZNA and nocturnal GERD?
Phathom published Phase 3 pHalcon-NERD-301 analyses showing rapid and sustained nocturnal symptom relief with VOQUEZNA in 772 patients, with Week 4 mean heartburn-free nights of 59.9% (10 mg) and 56.4% (20 mg) vs 43.3% placebo.
How quickly did VOQUEZNA (PHAT) reduce nighttime heartburn in the pHalcon-NERD-301 trial?
Separation from placebo was observed after the first dose: 45.3% (10 mg) and 52.4% (20 mg) had a heartburn-free night vs 32.1% on placebo.
Are VOQUEZNA’s nocturnal symptom benefits durable for PHAT patients?
Yes; median heartburn-free nights remained above 70% across treatment groups through the 20-week blinded extension.
What safety findings did Phathom report for VOQUEZNA in the NERD trial?
VOQUEZNA was generally well tolerated; most common AEs were ≤3% in the 4-week period and ≤5% in the 20-week extension (eg, nausea, URTI, sinusitis).
How should investors interpret the statistical significance in Phathom’s NERD publication (PHAT)?
The Week 4 differences reported a nominal pexploratory and not adjusted for multiple comparisons.
What indications does VOQUEZNA have in the U.S. relevant to PHAT shareholders?
VOQUEZNA is approved in adults for healing and maintenance of erosive GERD, relief of heartburn associated with erosive and non-erosive GERD, and as part of H. pylori treatment regimens.
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