Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application
August 21, 2023 08:00 ET
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Phathom Pharmaceuticals
Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf lifeSubmission of...
Phathom Pharmaceuticals Reports Second Quarter 2023 Results
August 10, 2023 08:01 ET
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Phathom Pharmaceuticals
Prior Approval Supplement (PAS) for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2023 by the U.S. Food and Drug...
Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
June 12, 2023 08:01 ET
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Phathom Pharmaceuticals
Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023Combined launch of vonoprazan for Erosive GERD and H. pylori indications planned for Q4 2023, if approved FLORHAM PARK, N.J., June...
Phathom Pharmaceuticals to Participate in Upcoming Investor Conferences
June 01, 2023 08:00 ET
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA
May 23, 2023 16:00 ET
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Phathom Pharmaceuticals
Anticipated FDA action date in Q4 2023; if approved, combined launch for Erosive GERD and H. pylori indications planned before year endIf approved, vonoprazan would be the first innovative acid...
Phathom Pharmaceuticals Presents New Data at Digestive Disease Week® (DDW) 2023
May 09, 2023 08:00 ET
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Phathom Pharmaceuticals
Higher H. pylori eradication rates demonstrated with vonoprazan-based regimens vs. lansoprazole triple therapy, regardless of different baseline demographics and clinical characteristicsMeta-analysis...
Phathom Pharmaceuticals Announces Regulatory Update and Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch
April 04, 2023 08:00 ET
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Phathom Pharmaceuticals
Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug application (NDA) this quarterCombined commercial...
GLOBALLY RECOGNIZED ROSEN LAW FIRM Encourages Phathom Pharmaceuticals, Inc. Investors to Inquire About Securities Class Action Investigation – PHAT
February 14, 2023 20:40 ET
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The Rosen Law Firm PA
NEW YORK, Feb. 14, 2023 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, continues its investigation of potential securities claims on behalf of shareholders of Phathom...
TOP RANKED ROSEN LAW FIRM Encourages Phathom Pharmaceuticals, Inc. Investors to Inquire About Securities Class Action Investigation – PHAT
February 09, 2023 15:33 ET
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The Rosen Law Firm PA
NEW YORK, Feb. 09, 2023 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, continues its investigation of potential securities claims on behalf of shareholders of Phathom...
Phathom Pharmaceuticals Announces Positive Topline Results from Phase 3 PHALCON-NERD-301 Trial Evaluating Daily Dosing of Vonoprazan for Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)
January 08, 2023 18:00 ET
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Phathom Pharmaceuticals
Both vonoprazan 10 mg and 20 mg doses met the primary endpoint and showed highly statistically significant greater percentage of 24-hour heartburn free days as compared to placebo (p<0.0001)Data...