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 23, 2026, Phathom Pharmaceuticals, Inc. (“Phathom” or the “Company”) announced that BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) has filed suit against the U.S.…
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 2026-10-23
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On October 23, 2026, Phathom Pharmaceuticals, Inc. (“Phathom” or the “Company”) announced that BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) has filed suit against the U.S. Food and Drug Administration (“FDA”) and related Federal Defendants in the United States District Court for the District of Columbia, principally challenging FDA’s alleged refusal to receive an abbreviated new drug application (“ANDA”) referencing Phathom’s new drug application (“NDA”) for VOQUEZNA. In the suit, BDR alleges that FDA has improperly applied the GAIN Act to extend Phathom’s New Chemical Entity (“NCE”) exclusivity for VOQUEZNA (vonoprazan fumarate) tablets. Phathom is evaluating the BDR filings, but believes that FDA carefully and correctly evaluated this issue in its June 6, 2025 grant of Phathom’s December 11, 2024 Citizen Petition, in which FDA recognized 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032. Phathom intends to take appropriate action to protect its statutory exclusivities.