Pfizer Inc., PFE, FDA Calendar, PDUFA Date

Company Name	Pfizer Inc. PFE
Drug Name	Vepdegestrant (NDA)
Event Name	FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer
Event Date	06/05/2026
Outcome Date	05/01/2026
Outcome	FDA approved Vepdegestrant, under the brand name VEPPANU, for the treatment of ESR1m, ER+/HER2- advanced breast cancer on May 1, 2026
Drug Status	Vepdegestrant is being co-developed by Arvinas and Pfizer . Rigel will be responsible for the launch and commercialization of VEPPANU in the U.S. and will own global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S.
Rival Drugs	Menarini's Orserdu, AstraZeneca's Faslodex
Market Potential	If approved Vepdegestrant could achieve peak sales of $2 billion to $4 billion, according to analysts
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