Business
Phathom Pharmaceuticals Reports Second Quarter 2023 Results
Prior Approval Supplement (PAS) for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30,
About this update from Phathom Pharmaceuticals, Inc.
[{"type":"text","content":"Prior Approval Supplement (PAS) for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2023 by the U.S. Food and Drug Administration (FDA) U.S. commercial launch for H. pylori and Erosive GERD planned for Q4 2023Successfully completed Phase 3 PHALCON-NERD-301 trial for Non-Erosive GERD; regulatory submission on track to occur by year-end FLORHAM PARK, N.J., Aug. 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 second quarter of 2023 and provided updates on recent regulatory and business progress. “We made great progress advancing key regulatory, financial, and commercial priorities during the second quarter, highlighted by our regulatory submissions for both Erosive GERD and H. pylori convenience packs, the successful execution of a capital raise resulting in $141.4 million in net proceeds, and commencement of our salesforce recruiting in anticipation of our product launches in the fourth quarter,” said Terrie Curran, President and Chief Executive Officer of Phathom. “Our manufacturing and regulatory teams have worked diligently to address the impurity cited by the FDA in the complete response letters we received in February, and we are pleased that our regulatory applications have been assigned PDUFA action dates later this year. We remain focused on onboarding a high-performing field force and completing the final preparations for our anticipated commercial launches.” Clinical, Regulatory, and Business Updates: In June 2023, Phathom submitted a PAS to the FDA for both VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin). The submission of these supplements signifies a full response to the February 2023 complete response letter (CRL) and, subject to filing, the FDA has assigned a PDUFA goal date of October 30, 2023. The PAS contained three months of stability data supporting both VOQUEZNA-based convenience packs, which includes reformulated vonoprazan tablets, to support the commercial shelf life of vonoprazan. Phathom plans to provide six-month stability data during the regulatory review as previously agreed with the FDA...