04:30 PM EDT, 08/08/2025 (MT Newswires) -- Arvinas ( ARVN ) and Pfizer ( PFE ) said late Friday the US Food and Drug Administration accepted the new drug application for vepdegestrant to treat patients with advanced breast cancer who have previously received endocrine-based therapy.

The FDA assigned a Prescription Drug User Fee Act action date of June 5, 2026, the drugmakers said.

The application submission was based on data from a phase 3 trial evaluating the safety and efficacy of vepdegestrant versus fulvestrant, the companies said.

Vepdegestrant also received fast track designation by the FDA, they added.

Arvinas ( ARVN ) shares were up 1.8% during after-hours activity, while Pfizer ( PFE ) was slightly down.