Phathom Pharmaceuticals Resubmits FDA Application For Acid Blocker, Raises $131M Via Equity - Phathom Pharmaceuticals (NASDAQ:PHAT)

This resubmission responds to the Complete Response Letter issued by the FDA in February 2023 concerning specifications and controls for a nitrosamine drug substance-related impurity, N-nitroso-vonoprazan (NVP). The three-month data demonstrate Phathoms mitigation measures control NVP growth through three months and keep levels well below the acceptable daily intake limit of 96 ng/day. Phathom expects the application to be classified as a Class 2 resubmission with a six-month review period and plans to provide the FDA with six-month stability data from its ongoing stability program during the regulatory review process. A combined U.S. commercial launch for the Erosive GERD and H. pylori indications is planned for the fourth quarter of 2023 if approved. Concurrently, the company raised $130.7 million via an equity offering of 11.125 million shares at $11.75 per share.PHAT Price Action: Phathom Pharmaceuticals shares are down 11.23% at $11.60 at publication Wednesday.Read Next: Eloxx Pharmaceuticals Plans To Take ELX-02 Into Pivotal Trial For Alport Syndrome