FDA accepts Phathom's vonoprazan NDA resubmission for Erosive GERD; PDUFA date Nov 17, 2023

Phathom Pharmaceuticals, Inc.

FDA acknowledged NDA resubmission for vonoprazan, a PCAB, as complete response to the February 2023 CRL.
Classified as a Class 2 resubmission with a PDUFA goal date of November 17, 2023.
Resubmission included three months stability data of reformulated tablets to support commercial shelf life.
Additional stability data will be provided during review as previously agreed with the FDA.

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