11:20 AM EDT, 07/18/2024 (MT Newswires) -- Agenus ( AGEN ) said Thursday that the US Food and Drug Administration discouraged an accelerated approval pathway for its potential colorectal cancer combination treatment consisting of botensilimab and balstilimab.

"FDA advised against submission of [phase 2 trial] results in support of an accelerated approval based on their view that objective response rates may not translate to survival benefit," Agenus ( AGEN ) said.

The company said the regulator agreed with the dosing regimen for a phase 3 trial of the combination treatment and recommended the inclusion of a botensilimab monotherapy arm at the company's discretion in the phase 3 study.

Shares or Agenus ( AGEN ) slumped more than 56% in recent Thursday trading.

Price: 7.77, Change: -9.96, Percent Change: -56.18