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Phathom Pharmaceuticals Reports First Quarter 2023 Results
FLORHAM PARK, N.J., May 10, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"FLORHAM PARK, N.J., May 10, 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 first quarter of 2023 and provided updates on recent regulatory progress. “This quarter, we made remarkable progress advancing mission-critical priorities that position Phathom to potentially deliver vonoprazan to patients suffering from Erosive GERD and H. pylori infection before year end,” said Terrie Curran, President and Chief Executive Officer of Phathom. “Our ongoing stability program for the minor drug product reformulation continues to demonstrate effective control of the N-nitroso-vonoprazan (NVP) impurity and confirms our confidence that our planned NDA resubmission will address the sole deficiency cited in the FDA’s complete response letters. Building on this positive momentum, our commercial team continues to prepare for a planned fourth quarter commercial launch and we remain engaged with payers, healthcare providers, and key opinion leaders to capitalize on the blockbuster potential of our first-in-class therapy.” Clinical, Regulatory, and Business Updates: Phathom remains on track to resubmit its erosive esophagitis (Erosive GERD) NDA this quarter, with potential for FDA approval and a subsequent U.S. commercial launch for Erosive GERD and H. pylori infection anticipated in the fourth quarter of 2023. The Company’s ongoing stability program for the minor reformulation of vonoprazan drug product continues to demonstrate that it is achieving the intended effects of limiting and controlling NVP formation. Based on FDA feedback from the March 2023 meeting, Phathom believes the data package it expects to include in the resubmission will address the NVP issue, the sole deficiency noted in the FDA’s complete response letters (CRLs).In January 2023, Phathom shared positive topline results from the Phase 3 PHALCON-NERD-301 trial evaluating the daily dosing of vonoprazan for Non-Erosive GERD. Both vonoprazan 10 mg and 20 mg doses met the primary endpoint and showed highly statistically significant greater percentage of 24-hour heartburn free days as compared to placebo (p4, higher predicted Erosive GERD healing rates, and lower probabilities of failure to achieve healing...