FDA delays action on Phathom's vonoprazan EE NDA; nitrosamine impurity data required, launch pushed past Q1 2023

Phathom Pharmaceuticals, Inc.

FDA will not act by Jan 11, 2023 PDUFA date for vonoprazan erosive esophagitis NDA.
Acceptable daily intake for nitrosamine impurity NVP set at 96 ng/day; additional stability data required.
Phathom no longer expects product launches for H. pylori or EE in Q1 2023.
Company is generating additional stability data and discussing nature/extent with FDA.
Previously identified NVP impurity in commercial batches delays both indications.

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