Recent Updates — PHAT
The U.S. Food and Drug Administration established a public docket (Docket No. FDA-2026-N-13038) to solicit comment on legal and regulatory questions regarding the New Chemical Entity (NCE) exclusivity for VOQUEZNA tablets. The deadline for comments is November 23, 2026. This action follows litigation brought by BDR Pharmaceuticals against the FDA after it rejected an Abbreviated New Drug Application referencing VOQUEZNA. The FDA had previously granted Phathom’s Citizen Petition, agreeing that VOQUEZNA benefits from 10 years of NCE exclusivity through May 3, 2032. A second filer, Saba Ilac Sanayii Ve Ticaret AS, intends to consolidate its case with BDR’s. The outcome could impact the duration of Phathom's regulatory protection for its flagship product. Phathom Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing treatments for gastrointestinal diseases.
BDR Pharmaceuticals International Pvt. Ltd. filed suit against the U.S. Food and Drug Administration in the United States District Court for the District of Columbia, challenging the agency's refusal to receive an abbreviated new drug application referencing Phathom’s VOQUEZNA. BDR alleges that FDA improperly applied the GAIN Act to extend Phathom’s New Chemical Entity exclusivity through May 3, 2032. Phathom believes the FDA correctly evaluated the issue and intends to take action to protect its statutory exclusivities. The company operates in the pharmaceutical industry.
Phathom Pharmaceuticals announced the initiation of patient screening for pHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed dosing regimen of VOQUEZNA (vonoprazan) in adults with Non-Erosive Gastroesophageal Reflux Disease. The multicenter trial will enroll approximately 500 patients across roughly 80 U.S. sites and is expected to report topline results in the first quarter of 2028. If successful, the study aims to support a regulatory submission for label expansion. Phathom Pharmaceuticals operates in the biopharmaceutical industry, developing treatments for gastrointestinal disorders.
Phathom Pharmaceuticals reported second quarter 2026 financial results with net revenues of $74.3 million, an 88% increase year-over-year and a record for the period. The company achieved operating profitability excluding stock-based compensation, with total operating expenses reduced by 33% to $63.1 million compared to Q2 2025. Net loss narrowed significantly to $17.6 million from $75.8 million in the prior year quarter. Cash and cash equivalents stood at $182.5 million as of June 30, 2026. The company updated its full-year 2026 net revenue guidance downward to a range of $310–$325 million from the previous $320–$345 million estimate. Additionally, Phathom announced plans to initiate a Phase 3 clinical trial for as-needed dosing of VOQUEZNA in Non-Erosive GERD patients and reported completion of enrollment in its Phase 2 Eosinophilic Esophagitis trial. Phathom Pharmaceuticals is a biopharmaceutical company focused on the commercialization and development of novel treatments for gastrointestinal diseases.
Phathom Pharmaceuticals, Inc. announced the completion of patient enrollment for its Phase 2 pHalcon-EoE-201 clinical trial, which evaluates VOQUEZNA (vonoprazan) for the treatment of eosinophilic esophagitis (EoE) in adults. The randomized, double-blind, placebo-controlled study has enrolled 95 patients across 41 U.S. sites, with topline results expected in the fourth quarter of 2026. Phathom Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing gastrointestinal treatments.