Phathom Pharmaceuticals Inc (NASDAQ:PHAT) shares are trading higher Monday after the company announced FDA approval of its reformulated vonoprazan tablets. 

What Happened: Phathom said the FDA approved its prior approval supplement for its vonoprazan tablets for both Voquenza Triple Pak and Voquenza Dual Pak for the treatment of Helicobacter pylori infection in adults.

"H. pylori eradication failures are due to rising antibiotic resistance, inadequate acid suppression, and complex treatment regimens. We are excited about VOQUEZNA TRIPLE and DUAL PAKs, a new class of acid suppression therapy, that has the potential to address these issues and enhance H. pylori eradication," said Terrie Curran, president and CEO of Phathom.

The initial product approvals were based on safety and efficacy data from the Phase 3 PHALCON-HP trial. Phathom plans to host an investor call in November to discuss its U.S. commercial launch plans.

Phathom is a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases.

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PHAT Price Action: Phathom shares were up 4.85% at $9.08 at the time of publication, according to Benzinga Pro.

Photo: 3844328 from Pixabay.