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Biotech stocks Facing FDA Decision in January 2023

Phathom Pharmaceuticals
Phathom Pharmaceuticals

Phathom Pharmaceuticals Inc.’s (PHAT) New Drug Application for Vonoprazan is under standard review, with a decision expected on January 11, 2023.

Vonoprazan is proposed as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn.

In the U.S., Vonoprazan-based regimens are approved as part of a co-packaged product in combination with antibiotics for the treatment of H. pylori infection in adults, under brand names VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin).

If approved for erosive esophagitis, Vonoprazan will be marketed under brand name VOQUEZNA.

The company expects to launch VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK next quarter, as well as, if approved, VOQUEZNA tablets for EE.

PHAT closed Friday’s trading at $11.29, down 2.08%.