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Phathom Pharmaceuticals, Inc.
BDR Pharmaceuticals has filed a lawsuit against the FDA challenging the extension of NCE exclusivity for Phathom's drug, VOQUEZNA. Phathom Pharmaceuticals maintains that the FDA's previous grant of exclusivity through May 3, 2032, is correct and intends to take action to protect its statutory rights.…more
Phathom Pharmaceuticals, Inc.
Insider Sanjeev Narula of Phathom Pharmaceuticals reported a change in beneficial ownership of company securities effective October 6, 2026. This filing provides the details of the executive's stock holdings via Form 4.…more
Phathom Pharmaceuticals, Inc.
Phathom Pharmaceuticals has initiated patient screening for its Phase 3 clinical trial (pHalcon-NERD-302), evaluating the as-needed use of VOQUEZNA (vonoprazan) 10 mg for adults with Non-Erosive GERD. The study will enroll approximately 500 patients across 80 U.S. sites, with topline results expected in the first quarter of 2028.…more
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Phathom Responds to BDR Lawsuit Against FDA Over Voquezna ANDA
Phathom stated that the FDA correctly recognized its New Chemical Entity exclusivity for Voquezna until May 3, 2032. The company is defending its market position against a lawsuit challenging the FDA's approval process.…more
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BDR Pharmaceuticals has filed a lawsuit against the FDA challenging the extension of Phathom's regulatory exclusivity for its drug VOQUEZNA. Phathom maintains that the FDA's previous decision was correct and intends to take legal action to protect its statutory rights.…more
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Phathom Pharmaceuticals will release its third quarter 2026 financial results and provide a business update on October 29, 2026. Investors will be looking for updates on the company's business progress and the performance of its key products.…more
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