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FDA opens public docket on Phathom's Voquezna exclusivity dispute

Mon, 26 Oct 2026 06:05:36 -0400

Phathom Pharmaceuticals (Nasdaq: PHAT) announced that the U.S. Food and Drug Administration has opened a public docket to solicit comments on legal and regulatory questions related to litigation over the exclusivity status of its drug Voquezna (vonoprazan) tablets.

The docket, numbered FDA-2026-N-13038, was established in response to litigation filed by BDR Pharmaceuticals, International Pvt. Ltd., which challenged an FDA decision made on June 6, 2025. That decision granted Phathom's Citizen Petition, affirming that Voquezna holds 10 years of New Chemical Entity exclusivity through May 3, 2032. BDR had filed an abbreviated new drug application referencing Voquezna, which the FDA rejected. The

FDA opens public docket on Phathom's Voquezna exclusivity dispute

Mon, 26 Oct 2026 06:05:36 -0400

FDA opens public docket on Phathom's Voquezna exclusivity dispute

Mon, 26 Oct 2026 06:05:36 -0400

Form 8-K Phathom Pharmaceuticals, For: Oct 26

Mon, 26 Oct 2026 06:02:00 -0400

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Phathom Pharmaceuticals Provides Update on FDA Litigation

Mon, 26 Oct 2026 04:00:00 -0400

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,

Phathom Pharmaceuticals Provides Update on FDA Litigation

Mon, 26 Oct 2026 04:00:00 -0400

Form 8-K Phathom Pharmaceuticals, For: Oct 23

Fri, 23 Oct 2026 17:01:00 -0400

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

Fri, 23 Oct 2026 04:52:22 -0400

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)

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

Fri, 23 Oct 2026 04:00:00 -0400

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

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

Fri, 23 Oct 2026 04:00:00 -0400

Phathom Pharmaceuticals to Report Third Quarter 2026 Financial Results and Provide Business Update on Thursday, October 29, 2026

Mon, 19 Oct 2026 08:00:00 -0400

Management to host conference call on Thursday, October 29, 2026, at 8:00 am EDT

FLORHAM PARK, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal (GI) diseases, today announced that it will host a live webcast at 8:00 am EDT on Thursday, October 29, 2026, to report its third quarter 2026 financial results and provide a business update.

A live webcast and additional information about the presentation can be accessed on the Events & Presentations section of the Phathom website at

Phathom Pharmaceuticals to Report Third Quarter 2026 Financial Results and Provide Business Update on Thursday, October 29, 2026

Mon, 19 Oct 2026 08:00:00 -0400

Management to host conference call on Thursday, October 29, 2026, at 8:00 am EDT

A live webcast and additional information about the presentation can be accessed on the Events & Presentations section of the Phathom website at

Phathom Pharmaceuticals (PHAT) PT Lowered to $16 at Jefferies

Wed, 14 Oct 2026 04:53:21 -0400

Jefferies analyst Glen Santangelo lowered the price target on Phathom Pharmaceuticals (NASDAQ: PHAT) to $16.00 (from $20.00) while maintaining a Buy rating.

The analyst comments "Q3 should be in-line vs cons. PHAT had a tough year, but we really like the 2027 setup. Despite cons #s looking high, $500M cap suggests the buyside is way below already, and 2027 guidance should be a clearing event. Further, PHAT has a very (+) risk/reward into the competitor PCAB PDUFA in Jan 2027. Even if approved, two PCABs in the market should grow awareness and penetration for both + PHAT's salesforce will likely be

Phathom Pharmaceuticals (PHAT) PT Lowered to $16 at Jefferies

Wed, 14 Oct 2026 04:53:21 -0400

Jefferies analyst Glen Santangelo lowered the price target on Phathom Pharmaceuticals (NASDAQ: PHAT) to $16.00 (from $20.00) while maintaining a Buy rating.

Phathom data projects vonoprazan cost-effective vs. PPIs for GERD

Mon, 12 Oct 2026 08:03:29 -0400

Phathom Pharmaceuticals (Nasdaq: PHAT) presented new cost-effectiveness and clinical data for its drug VOQUEZNA (vonoprazan) at the American College of Gastroenterology's 2026 Annual Scientific Meeting in Nashville, Tennessee, held October 9–14.

A predictive Markov model analyzed lifetime clinical and economic outcomes of VOQUEZNA versus proton pump inhibitors (PPIs) in commercially insured U.S. adults with Erosive GERD, starting at a mean age of 51.3 years. The model projected that VOQUEZNA would result in fewer downstream complications, such as esophageal adenocarcinoma and related deaths, compared with PPIs.

At an estimated net price, the model projected healthcare savings for VOQUEZNA over PPIs in both the

Phathom data projects vonoprazan cost-effective vs. PPIs for GERD

Mon, 12 Oct 2026 08:03:29 -0400

At an estimated net price, the model projected healthcare savings for VOQUEZNA over PPIs in both the

Phathom Pharmaceuticals Highlights New Cost-Effectiveness Data and Growing Clinical Interest in VOQUEZNA® (vonoprazan) at ACG 2026

Mon, 12 Oct 2026 08:00:00 -0400

New analysis projects VOQUEZNA® (vonoprazan) to provide meaningful economic value and be cost-effective vs. proton pump inhibitors (PPIs) for adults with Erosive GERD, with potential cost savings at net price based on clinical healing and maintenance-of-healing data and fewer anticipated downstream complications
Additional Phathom-sponsored data highlight VOQUEZNA treatment effect across BMI subgroups in Non-Erosive GERD and real-world patient characteristics
Vonoprazan was also the subject of 38 independent, investigator-initiated abstracts presented at ACG 2026, spanning GERD, H. pylori eradication, and other gastrointestinal conditions

FLORHAM PARK, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals,

Phathom Pharmaceuticals Highlights New Cost-Effectiveness Data and Growing Clinical Interest in VOQUEZNA® (vonoprazan) at ACG 2026

Mon, 12 Oct 2026 08:00:00 -0400

New analysis projects VOQUEZNA® (vonoprazan) to provide meaningful economic value and be cost-effective vs. proton pump inhibitors (PPIs) for adults with Erosive GERD, with potential cost savings at net price based on clinical healing and maintenance-of-healing data and fewer anticipated downstream complications
Additional Phathom-sponsored data highlight VOQUEZNA treatment effect across BMI subgroups in Non-Erosive GERD and real-world patient characteristics
Vonoprazan was also the subject of 38 independent, investigator-initiated abstracts presented at ACG 2026, spanning GERD, H. pylori eradication, and other gastrointestinal conditions

FLORHAM PARK, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals,

Form 4 Phathom Pharmaceuticals, For: Oct 06 Filed by: Narula Sanjeev

Thu, 08 Oct 2026 17:45:00 -0400

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Phathom to present Voquezna data at ACG 2026 meeting

Thu, 08 Oct 2026 08:00:40 -0400

Phathom Pharmaceuticals (Nasdaq: PHAT) will present three scientific posters on its drug Voquezna (vonoprazan) at the American College of Gastroenterology 2026 Annual Scientific Meeting, held October 9-14 in Nashville, Tennessee.

The presentations will cover new analyses related to Gastroesophageal Reflux Disease (GERD), including a post hoc analysis of Voquezna efficacy across body mass index subgroups in patients with non-erosive GERD, a retrospective analysis of real-world patient characteristics, and a Markov model examining cost-effectiveness of Voquezna compared with proton pump inhibitors (PPIs) in erosive esophagitis.

The BMI subgroup poster is scheduled for October 11, followed by the real-world patient characteristics poster on October

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

Thu, 08 Oct 2026 08:00:00 -0400

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.

Phathom will present three scientific posters featuring new data and analyses for VOQUEZNA^® (vonoprazan) in Gastroesophageal Reflux Disease

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

Thu, 08 Oct 2026 08:00:00 -0400

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

Phathom will present three scientific posters featuring new data and analyses for VOQUEZNA^® (vonoprazan) in Gastroesophageal Reflux Disease

Form 8-K Phathom Pharmaceuticals, For: Sep 29

Tue, 29 Sep 2026 16:46:00 -0400

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Phathom starts Phase 3 trial of Voquezna for on-demand GERD use

Tue, 29 Sep 2026 08:00:28 -0400

Phathom Pharmaceuticals (Nasdaq: PHAT) announced the start of patient screening for pHalcon-NERD-302, a Phase 3 clinical study evaluating an as-needed dosing regimen of its drug VOQUEZNA (vonoprazan) in adults with Non-Erosive Gastroesophageal Reflux Disease (NERD). Topline results are expected in the first quarter of 2028.

The multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 500 adults who report heartburn at least four days per week, across roughly 80 sites in the U.S. After a four-week open-label run-in period with VOQUEZNA 10 mg once daily, eligible patients will be randomized to receive either VOQUEZNA 10 mg or placebo on an as-needed basis

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

Tue, 29 Sep 2026 08:00:00 -0400

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),