Why Phathom Pharmaceuticals (PHT) Shares Are Plunging Today - Phathom Pharmaceuticals (NASDAQ:PHAT)

The FDA notified Phathom Pharmaceuticals Inc PHAT that no action would be taken on the company's new drug application (NDA) for vonoprazan, under review as a treatment for erosive esophagitis, on or before the current Prescription Drug User Fee Act (PDUFA) target action date of January 11, 2023.
Erosive esophagitis is a type of inflammation in which there is damage to the tissue lining.
In August 2022, the company detected trace levels of a nitrosamine impurity, N-nitroso-vonoprazan (NVP), in commercial batches. It was working closely with the FDA to obtain approval for a proposed acceptable daily intake limit, test method, and controls to address this impurity.
While an acceptable daily intake limit for NVP has now been established by the FDA at 96 ng/day, the FDA has requested additional stability data demonstrating that levels of NVP remain below that limit throughout the proposed shelf life of the product.
As a result, Phathom no longer expects product launches for H. pylori or erosive esophagitis in Q1 2023.
Price Action: PHAT shares are down 24.43% at $9.06 during the premarket session on the last check Wednesday.
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FDA Issues No Action Notice For Phathom Pharma's Investigational Candidate, Shares Plunge