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Biotech Stocks Facing FDA Decision In November 2023

Phathom Pharmaceuticals
Phathom Pharmaceuticals

The FDA decision on Phathom Pharmaceuticals Inc.’s (PHAT) Vonoprazan, proposed for the treatment of erosive GERD, is due on November 17, 2023.

Erosive GERD, also referred to as erosive esophagitis, is a major type of GERD (gastroesophageal reflux disease), characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus.

This marks the company's second attempt to obtain FDA approval for Vonoprazan.

The FDA had declined to approve Vonoprazan in February of this year due to issues concerning the specifications and controls for a nitrosamine drug substance impurity known as N-nitroso-vonoprazan.

PHAT closed Friday’s trading at $8.66, up 1.64%.