Phathom Pharmaceuticals, Inc. logo PHAT - Phathom Pharmaceuticals, Inc.

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Phathom Pharmaceuticals Provides Update on FDA Litigation

Phathom Pharmaceuticals Provides Update on FDA Litigation

FLORHAM PARK, N.J., Oct. 26, 2026 (GLOBE NEWSWIRE) -- 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.

Oct 26, 2026 12:00 AM • globenewswire.com
Phathom Pharmaceuticals Provides Update on Litigation Filed by BDR Pharmaceuticals against FDA

Phathom Pharmaceuticals Provides Update on Litigation Filed by BDR Pharmaceuticals against FDA

FLORHAM PARK, N.J., Oct. 23, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal (GI) diseases, announced today 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.

Oct 23, 2026 12:00 AM • globenewswire.com
Phathom Pharmaceuticals to Present New Data and Analyses for VOQUEZNA® (vonoprazan) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting

Phathom Pharmaceuticals to Present New Data and Analyses for VOQUEZNA® (vonoprazan) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting

Three scientific presentations will highlight new analyses of VOQUEZNA® (vonoprazan) in GERD, including real-world patient characteristics, efficacy across BMI subgroups, and cost-effectiveness in Erosive Esophagitis FLORHAM PARK, N.J., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced its participation in the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, being held October 9-14 in Nashville, Tennessee.

Oct 08, 2026 04:00 AM • globenewswire.com
Phathom Pharmaceuticals Announces Initiation of Registrational Phase 3 Study of VOQUEZNA® (vonoprazan) for As-Needed Treatment of Non-Erosive GERD

Phathom Pharmaceuticals Announces Initiation of Registrational Phase 3 Study of VOQUEZNA® (vonoprazan) for As-Needed Treatment of Non-Erosive GERD

Initiation of registrational Phase 3 study of VOQUEZNA® (vonoprazan) for as-needed (PRN) use in Non-Erosive Reflux Disease (NERD) builds on previously reported positive Phase 2 data Topline results expected in the first quarter of 2028 pHalcon-NERD-302, if successful, is intended to support a potential VOQUEZNA label expansion to include as-needed treatment of heartburn episodes in patients with Non-Erosive GERD, a treatment regimen of interest to patients for which proton pump inhibitors (PPIs) are not currently approved in the U.S. FLORHAM PARK, N.J., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases, today announced the initiation of patient screening in pHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed (PRN or on-demand) investigational dosing regimen of VOQUEZNA® (vonoprazan) tablets in adults with Non-Erosive Gastroesophageal Reflux Disease, or Non-Erosive GERD (NERD).

Sep 29, 2026 04:00 AM • globenewswire.com
Levi & Korsinsky Notifies Investors of Pending Investigation Into Securities Claims Involving Phathom Pharmaceuticals, Inc. (PHAT)

Levi & Korsinsky Notifies Investors of Pending Investigation Into Securities Claims Involving Phathom Pharmaceuticals, Inc. (PHAT)

Phathom Pharmaceuticals' revised FY 2026 revenue outlook of $310 million -- $325 million came in below the roughly $332 million -- $334 million analysts were modeling, and PHAT shares sold off on the news Phathom Pharmaceuticals' revised FY 2026 revenue outlook of $310 million -- $325 million came in below the roughly $332 million -- $334 million analysts were modeling, and PHAT shares sold off on the news

Aug 04, 2026 06:09 AM • globenewswire.com (Hide legal announcements)
PHAT Investor Alert: Levi & Korsinsky Notifies Investors of Investigation Into Phathom Pharmaceuticals, Inc. (PHAT)

PHAT Investor Alert: Levi & Korsinsky Notifies Investors of Investigation Into Phathom Pharmaceuticals, Inc. (PHAT)

NEW YORK--(BUSINESS WIRE)--Phathom Pharmaceuticals, Inc. (NASDAQ: PHAT) shareholders took losses after the Company lowered its full-year 2026 revenue guidance to $310 million–$325 million from its previously issued $320 million–$345 million range, falling below Wall Street consensus estimates of approximately $332 million. If you suffered a loss on your Phathom Pharmaceuticals investment, you are encouraged to click here to submit your information. You may also contact Joseph E. Levi, Esq. via.

Aug 03, 2026 06:07 AM • businesswire.com (Hide legal announcements)
Phathom Pharmaceuticals Completes Patient Enrollment Ahead of Schedule in Phase 2 pHalcon-EoE-201 Study of VOQUEZNA® (vonoprazan) in Eosinophilic Esophagitis (EoE)

Phathom Pharmaceuticals Completes Patient Enrollment Ahead of Schedule in Phase 2 pHalcon-EoE-201 Study of VOQUEZNA® (vonoprazan) in Eosinophilic Esophagitis (EoE)

This trial is the first large, placebo-controlled clinical trial of an acid suppression treatment in EoE Topline results for the double-blind 12-week treatment portion of the study are expected in Q4 of 2026 FLORHAM PARK, N.J., June 23, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced it has completed enrollment in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQUEZNA® (vonoprazan) tablets as an investigational treatment for eosinophilic esophagitis (EoE) in adults.

Jun 23, 2026 03:59 AM • globenewswire.com

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