Phathom's NDA for VOQUEZNA in Non-Erosive GERD accepted by FDA; PDUFA date July 19, 2024

Phathom Pharmaceuticals, Inc.

FDA accepted NDA for VOQUEZNA (vonoprazan) for daily heartburn treatment in Non-Erosive GERD.
Standard 10-month review assigned; PDUFA target action date is July 19, 2024.
Plans to initiate an additional Phase 3 study in 2024 evaluating VOQUEZNA for As Needed episodic heartburn relief.
No PPIs are currently approved for as-needed use in Non-Erosive GERD, a potential differentiation.

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