• Phathom Pharmaceuticals Inc PHAT resubmitted its marketing application to the FDA seeking approval for vonoprazan for Erosive GERD (gastroesophageal reflux disease), also referred to as erosive esophagitis.


• 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 resubmission contains three months of stability data for six batches of the reformulated vonoprazan tablets. 


• The three-month data demonstrate Phathom's mitigation measures control NVP growth through three months and keep levels well below the acceptable daily intake limit of 96 ng/day.


• All of the manufactured reformulated batches have demonstrated control of NVP through three months of long-term stability conditions that are more than tenfold below the acceptable intake limit, which Phathom believes supports the requested shelf life of 24 months.


• 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.

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