Business
Phathom Pharmaceuticals Reports Third Quarter 2021 Results and Provides Key Clinical, Regulatory, and Business Updates
Two New Drug Applications (NDAs) for vonoprazan-based treatment regimens for H. pylori infection were accepted for filing by FDA with six-month Priority
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Two New Drug Applications (NDAs) for vonoprazan-based treatment regimens for H. pylori infection were accepted for filing by FDA with six-month Priority Review granted; PDUFA target action date of May 3, 2022U.S. launch for both vonoprazan-based treatment regimens for H. pylori anticipated in the second half of 2022, if approvedPositive Phase 3 trial results for vonoprazan in erosive esophagitis (EE) reported in October 2021; NDA submission targeted for the first quarter of 2022 FLORHAM PARK, N.J., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the third quarter of 2021 and provided updates regarding recent clinical, regulatory, and business progress. “Phathom continued its strong execution through the third quarter of 2021, delivering impressive topline results from our pivotal Phase 3 PHALCON-EE study. The PHALCON-EE data adds to our excitement about vonoprazan’s potential to satisfy large unmet patient needs in the U.S. and European erosive esophagitis market,” said Terrie Curran, Phathom’s President and Chief Executive Officer. “With the recent acceptance of both NDAs for vonoprazan-based treatments in H. pylori, and the planned submission of an NDA for vonoprazan in EE in the first quarter of 2022, we are enthusiastic about vonoprazan’s potential to offer a novel treatment option to address the significant unmet needs that exist for so many patients across these prevalent acid-related disorders.” Clinical and Regulatory Updates: The U.S. Food and Drug Administration (FDA) accepted NDAs for two convenience packs containing vonoprazan-based treatment regimens for adults with H. pylori infection: vonoprazan in combination with amoxicillin and clarithromycin (“vonoprazan triple therapy”) and vonoprazan in combination with amoxicillin (“vonoprazan dual therapy”). The NDAs were granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target action date of May 3, 2022. Phathom submitted the NDAs to the FDA on September 3, 2021. The FDA previously designated vonoprazan dual and triple therapy as qualified infectious disease products (QIDPs) which, if approved, will provide vonoprazan five additional yea...