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Agenus to Withdraw Biologics License Application for Cervical Cancer Drug Candidate; Shares Fall Pre-Bell

9:22AM ET 10/22/2021 MT Newswires
Agenus (AGEN) said Friday it is withdrawing its biologics license application for cervical cancer drug candidate balstilimab at the recommendation of the US Food and Drug Administration, following the approval of pembrolizumab.

The company will also discontinue its ongoing confirmatory trial on balstilimab but will still move ahead with its development plans for balstilimab combinations. It will launch a development program combining balstilimab with AGEN1181 in multiple tumor types, it added.

The discontinuation of the Brava clinical trial is expected to reduce research and development expenses by more than $100 million.

Shares in the drugmaker were 22.4% lower in recent Friday premarket activity.