Phathom Pharmaceuticals

7 articles about Phathom Pharmaceuticals

• Phathom Pharmaceuticals to Participate in Upcoming Investor Conferences

  4/12/2023

  Phathom Pharmaceuticals, Inc. announced today that members of its management team will participate in the following upcoming investor conferences.

• Phathom Pharmaceuticals Announces Regulatory Update and Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch

  4/4/2023

  Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today provided a regulatory update following its recent meeting with the FDA regarding the complete response letters (CRLs) for Phathom’s erosive esophagitis NDA and H. pylori post approval supplement (PAS) to VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® NDAs.

• Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

  2/28/2023

  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.

• 

  Phathom Faces Another Delay with H. pylori, Esophagitis Drugs

  2/10/2023

  The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities in its Helicobacter pylori drug products.

• Phathom Pharmaceuticals Provides Regulatory Updates

  2/9/2023

  Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced regulatory updates for its approved products, VOQUEZNA™ TRIPLE PAK™ and VOQUEZNA DUAL PAK™, approved in the U.S. for the treatment of H. pylori infection, and its pending New Drug Application (NDA) for vonoprazan for the treatment of erosive esophagitis.

• Phathom Pharmaceuticals Announces Positive Topline Results from Phase 3 PHALCON-NERD-301 Trial Evaluating Daily Dosing of Vonoprazan for Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)

  1/8/2023

  Phathom Pharmaceuticals, Inc. announced positive topline results from PHALCON-NERD-301, a Phase 3 study evaluating the efficacy and safety of vonoprazan for the daily treatment of adults in symptomatic non-erosive gastroesophageal reflux disease.

• Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis

  1/3/2023

  Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that no action will be taken on the Company’s new drug application (NDA) for vonoprazan, a novel potassium-competitive acid blocker (PCAB), under review as a treatment for erosive esophagitis, on or prior to the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.