Needham analyst Joseph Stringer lowered the firm’s price target on Phathom Pharmaceuticals to $25 from $38 but keeps a Buy rating on the shares after the company’s disclosed that the FDA will not take action on the vonoprazan Erosive Esophagitis NDA on or before the PDUFA due to its request for additional stability data related to the nitrosamine impurity. Commentary from Phathom management indicates that the FDA has established an acceptable daily intake limit for the impurity, and the agency is requesting additional stability testing, Stringer tells investors in a research note. The analyst adds that while no details yet exist on a new PDUFA, the management remains "very confident" in a 2023 launch.
Published first on TheFly
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