By Chris Wack


Phathom Pharmaceuticals Inc. shares were down 39%, to $7.36, after the company said it was delaying the launch of vonoprazan.

The biopharmaceutical company said late Tuesday that the U.S. Food and Drug Administration has notified it that no action will be taken on the new drug application for vonoprazan, a novel potassium-competitive acid blocker, under review as a treatment for erosive esophagitis, on or prior to the current Prescription Drug User Fee Act target action date of Jan. 11, 2023.

On Aug. 2, the company said it had detected trace levels of a nitrosamine impurity, N-nitroso-vonoprazan 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.

Phathom said it is actively in the process of both generating additional stability data and discussing with the FDA the nature and extent of such requested data. As a result, Phathom no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.

Needham cut its price target for Phathom shares to $25 from $38 a share, while maintaining its "Buy" rating. BMO Capital cut its price target to $35 from $38 a share, while keeping its "Outperform" rating.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

01-04-23 1012ET