Phathom provides regulatory update on path to resubmit EE NDA in Q2 2023; launch expected Q4 2023

Phathom Pharmaceuticals, Inc.

Met with FDA; CRLs solely related to nitrosamine impurity NVP; mitigation includes minor tablet reformulation.
Stability data shared with FDA; anticipates resubmitting EE NDA in Q2 2023, with combined EE/H. pylori launch in Q4 2023.
Also plans to submit PAS for H. pylori; FDA action expected in Q4 2023.

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