Shares of Agenus Inc. (AGEN) tanked nearly 60% on Thursday morning after the U.S. FDA discouraged accelerated approval pathway for colon cancer treatment.
AGEN is currently trading at $7.17, down $10.56 or 59.53%, on the Nasdaq. The stock opened its trading at $6.96 after closing Wednesday at $17.73. The stock has traded between $4.78 and $34.20 in the past 52-week period.
Agenus announced the results of its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), for the advancement of its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer with no active liver metastases (NLM).
The company said topline interim data suggest best activity seen at 75 mg BOT/240mg BAL combination.
FDA advised against submission of these results in support of an Accelerated Approval based on their view that objective response rates may not translate to survival benefit.
The FDA recommended the inclusion of a BOT monotherapy arm at Agenus' discretion in the Phase 3 study.
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