PHAT - Phathom stock rises on vonoprazan refiling plans following FDA meet

2023-04-04 09:38:49 ET

Phathom Pharmaceuticals ( NASDAQ: PHAT ) stock rose ~10% on Tuesday after the company said it expects to refile an application seeking approval of vonoprazan to treat erosive esophagitis in Q2 2023 following a meeting with the U.S. FDA.

In February, Phathom received response from the FDA formally asking for additional stability data for the vonoprazan products. The data is to assure the U.S. drug regulator that levels of a nitrosamine impurity, N-nitroso-vonoprazan (NVP), previously found in commercial batches, will be at or below daily acceptable intake throughout the drug's shelf life. In August 2022, the company had found trace amounts of NVP in commercial batches of the drug.

Phathom said on Tuesday that it recently met with the FDA regarding the complete response letters (CRLs) for the erosive esophagitis NDA and H. pylori post approval supplement (PAS) to Voquezna TRIPLE PAK and Voquezna DUAL PAK NDAs. Both CRLs were solely related to specifications and controls for NVP.

The company added that it since detecting NVP, it investigated and implemented mitigation measures, including a minor tablet reformulation, to inhibit the growth of NVP.

Phathom noted that it shared available stability data with the FDA on this reformulation and received feedback on refiling requirements, including the expected stability data needed.

Based on this, Phathom expects refiling the NDA for erosive esophagitis in Q2 2023 which if approved, could lead to a combined commercial launch of the erosive esophagitis and H. pylori uses in Q4 2023, according to the company.

Phathom also expects submitting a PAS for Voquezna TRIPLE PAK and Voquezna DUAL PAK, with FDA action anticipated in Q4 2023.

"We believe the data package, including stability data that we have shared with the Agency, and which we continue to generate, demonstrate that the mitigation measures we have implemented are successfully achieving their intended effects of limiting and controlling NVP, the sole deficiency noted in the prior CRLs," said Phathom President and CEO Terrie Curran.

Esophagitis is an inflammation of the esophagus which can cause difficulty in swallowing and chest pain.

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