Phathom Pharmaceuticals (NASDAQ: PHAT) shares plunged more than 24% in after-hours trading on Tuesday after a disappointing update regarding its new drug application (NDA) for vonoprazan.
The biopharmaceutical company announced today that the U.S. FDA will take no action on its NDA for vonoprazan which is currently under review on or prior to the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
Vonoprazan is a novel potassium-competitive acid blocker (PCAB) used as a treatment for erosive esophagitis. Erosive esophagitis is a severe form of gastroesophageal reflux disease (GERD, or acid reflux).
In August last year, PHAT announced that it had detected ” trace levels of a nitrosamine impurity, N-nitroso-vonoprazan (NVP) in commercial batches and was working closely with the FDA to obtain approval of a proposed acceptable daily intake limit, test method, and controls to address this impurity prior to releasing vonoprazan-based products to the market.”
While an acceptable daily intake limit had now been established, the FDA has now requested additional stability data.
Analysts are bullish about PHAT stock with a Strong Buy consensus rating based on five unanimous Buys.
