Submission based on positive results from Phase 3 PHALCON-NERD-301 in which vonoprazan 10 mg and 20 mg controlled heartburn symptoms through the entire 6 months of the study with a safety profile consistent with prior vonoprazan studiesNew drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for vonoprazan as a daily treatment for Non-Erosive GERD, the largest subcategory of GERD with an estimated U.S.

根据第3阶段PHALCON-NERD-301的积极结果提交报告，其中vonoprazan 10 mg和20 mg在整个6个月的研究中控制胃灼热症状，其安全性与之前的vonoprazan研究一致新药申请（NDA）寻求美国食品和药物管理局（FDA）批准vonoprazan作为非糜烂性GERD的日常治疗，估计美国的GERD最大的子类别。

adult population of 38 millionFDA action date for Non-Erosive GERD NDA expected in the third quarter of 2024 FLORHAM PARK, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease (GERD) in adults.

2024年9月26日（GLOBE NEWSWIRE）-Phatom Pharmaceuticals，Inc。（纳斯达克股票代码：PHAT），一家专注于开发和商业化胃肠（GI）疾病新疗法的生物制药公司，今天宣布向FDA提交一份NDA，用于vonoprazan作为成人非糜烂性胃食管反流病（GERD）的日常治疗。

The regulatory submission is supported by the positive data from the PHALCON-NERD-301 study, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults with Non-Erosive GERD (NERD). Vonoprazan is an investigational first-in-class potassium-competitive acid blocker (PCAB) from a novel class of medicines that block acid secretion in the stomach.

PHALCON-NERD-301研究的积极数据支持了监管提交，该研究是一项评估vonoprazan对非糜烂性GERD（NERD）成人日常治疗疗效和安全性的3期研究。Vonoprazan是一种研究性一流的钾竞争性酸阻断剂（PCAB），来自一类阻断胃中酸分泌的新型药物。

“The submission of the NERD daily dosing NDA represents a major potential advancement for the estimated 38 million adults in the U.S. suffering from the symptoms of Non-Erosive GERD, many of whom are dissatisfied with currently available therapies,” said Terrie Curran, President and Chief Executive Officer at Phathom.

Phathom总裁兼首席执行官Terrie Curran说：“提交NERD每日剂量NDA代表了美国约3800万成年人患有非糜烂性GERD症状的重大潜在进展，其中许多人对目前可用的治疗方法不满意。”。

“Our NDA is supported by the results of our successfully completed PHALCON-NERD-301 study, which demonstrated vonoprazan’s durable 24-hour heartburn control over six months a.

“我们的NDA得到了我们成功完成的PHALCON-NERD-301研究结果的支持，该研究证明了vonoprazan在六个月内持久的24小时胃灼热控制。