Common Stock, par value $0.0001 per share
- Symbol
- PHAT
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 8.01 · 8-K
Phathom Pharmaceuticals, Inc.
PHATNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On October 26, 2026, Phathom Pharmaceuticals, Inc. (“Phathom” or the “Company”) announced the U.S. Food and Drug Administration’s (“FDA’s”) establishment of a public docket (Docket No.…
Company context
Phathom Pharmaceuticals is a biopharmaceutical company focused on the commercialization and development of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) for the U.S., Europe and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) and VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X.
Current securities
Registered securities in this filing
PHATHOM PHARMACEUTICALS, INC. · 8-K · Filed 2026-10-26
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On October 26, 2026, Phathom Pharmaceuticals, Inc. (“Phathom” or the “Company”) 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, Intl. 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.
Phathom believes the FDA carefully reviewed the NCE exclusivity period applicable to VOQUEZNA through a full public process and reached the right decision, which exclusivity remains in effect. Phathom will make that case clearly in its comments to the FDA and in any appropriate court proceeding.
A second purported ANDA filer, Saba Ilac Sanayii Ve Ticaret AS, has filed a notice in the BDR litigation claiming to have a pending related case, and that it intends to move to consolidate its case with BDR’s.