PHAT - Phathom: Undervalued Biotech With Possible GERD Treatment Label Expansion

2024-03-18 01:19:05 ET

Summary

• The FDA has set a target action date of July 19, 2024, for expanded approval of Voquenza, which would target the larger Non-Erosive GERD patient population.
• The global market for GERD therapies is expected to be $3.4 billion by 2032.
• A soon-to-be-initiated phase 3 study in 2024 is going to explore the use of Voquenza with "As Needed" dosing to treat Non-Erosive GERD patients.
• Voquenza may also be used to treat patients with another gastrointestinal disorder, such as eosinophilic esophagitis. A phase 2 study using this drug to treat this patient population is expected to be initiated in 2024.

Phathom Pharmaceuticals ( PHAT ) is a good biotech to keep an eye on in the coming months because it is gearing up to potentially receive an expanded FDA approval of its drug Voquenza as a daily treatment for heartburn in patients with non-erosive gastroesophageal reflux disease [GERD]. The U.S. agency accepted the application filing of Voquenza for the treatment of this patient population. The reason why investors should be concerned about this is because the FDA has already set a Prescription Drug User Fee Act [PDUFA] target action date of July 19, 2024. Not only that, but this would be an expanded label to target a much larger portion of the GERD market. The reason why is that Phathom Pharmaceuticals had already received FDA approval for Voquenza for patients with erosive GERD back in 2023....

For further details see: