Phathom Pharmaceuticals Provides Update on FDA Litigation

FLORHAM PARK, N.J., Oct. 26, 2026 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal (GI) diseases, today announced the U.S. Food and Drug Administration’s (FDA’s) establishment of a public docket (Docket No. FDA-2026-N-13038) to solicit comment on legal and regulatory questions regarding certain issues raised by a filer of an abbreviated new drug application (ANDA) referencing VOQUEZNA® (vonoprazan) tablets, BDR Pharmaceuticals, International Pvt. Ltd. (BDR), in litigation brought against the FDA following FDA’s rejection of the ANDA. The litigation was brought to challenge FDA’s June 6, 2025 decision granting Phathom’s Citizen Petition, which agreed with Phathom that VOQUEZNA benefits from 10 years of New Chemical Entity (NCE) exclusivity through May 3, 2032. The deadline for comments submitted to the public docket is November 23, 2026.