PHAT - Phathom Pharma sinks 25% after FDA won't act on vonoprazan NDA for erosive esophagitis

• Phathom Pharmaceuticals ( NASDAQ: PHAT ) plunged 25% in after-hours trading on Tuesday after it was informed by the US FDA that the agency would not render a decision on its vonoprazan NDA for erosive esophagitis by the Jan. 11 PDUFA date .
• In early August 2022, the company found trace amounts of a nitrosamine impurity, N-nitroso-vonoprazan (NVP), in commercial batches of the drug. Since then, it has been working with the FDA on an acceptable daily intake limit and ways to control the impurity prior to vonoprazan hitting the market.
• While the FDA has established an intake limit for the impurity, the agency wants additional data showing that levels of NVP remain below that limit throughout the shelf life of the product.
• As a result, Phathom ( PHAT ) will not be able to launch vonoprazan in Q1 as planned.
• Check out why Seeking Alpha contributor Avisol Capital Partners called Phathom ( PHAT ) a buy in November 2022.

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