Business
Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Meeting scheduled in March 2023 with the U.S. Food and Drug Administration (FDA) to discuss stability data and resubmission requirements for erosive GERD and
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Meeting scheduled in March 2023 with the U.S. Food and Drug Administration (FDA) to discuss stability data and resubmission requirements for erosive GERD and H. pylori New Drug Applications FLORHAM PARK, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update. “Over the past year, our teams made significant progress to advance the development and commercial potential of vonoprazan. We obtained FDA approval of our first products, aligned with the FDA on a near final label for erosive GERD, and delivered our third positive Phase 3 trial for vonoprazan in a third potential indication,” said Terrie Curran, President and Chief Executive Officer of Phathom. “While our anticipated commercial launch is on hold pending resolution of the previously announced nitrosamine impurity issue, we are confident in the progress we have made in generating additional stability data, and based on initial testing results, we believe the mitigation measures put in place are achieving their intended effects. We have a meeting scheduled with the FDA in March to discuss our proposed resubmission plan and align on potential review timelines to help make vonoprazan available to patients as soon as possible. We look forward to meeting with the FDA and expect to share more details about our progress once we have obtained additional clarity.”Full Year 2022 and Recent Business Highlights: Phathom delivered positive topline results for the primary endpoint from its third Phase 3 trial, PHALCON-NERD-301, evaluating the daily dosing of vonoprazan for the treatment of non-erosive gastroesophageal reflux disease (GERD) in adults. In the four-week placebo-controlled period of the study, both vonoprazan doses (10 mg and 20 mg) met the primary endpoint by showing a statistically significant greater percentage of 24-hour heartburn free days as compared to placebo (p","length":2509,"tagName":"div"}]