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© 2026 Benzinga | All Rights Reserved

May 24, 2023 12:31 PM 1 min read

Phathom Pharmaceuticals Resubmits FDA Application For Acid Blocker, Raises $131M Via Equity

by Vandana Singh Benzinga Editor

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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

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PHATPhathom Pharmaceuticals Inc

Phathom Pharmaceuticals Inc (NASDAQ: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.

PHATPhathom Pharmaceuticals Inc

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