AGEN - Agenus Faces Regulatory and Financial Challenges: Analyst Downgrades Stock Pending Trial Clarity | Benzinga
Thursday, Agenus Inc. (NASDAQ:AGEN) announced the results of its end-of-Phase 2 meeting with the FDA to advance its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for adult patients with relapsed/refractory microsatellite-stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).
The FDA discouraged the accelerated approval pathway and advised against submitting these results to support an Accelerated Approval based on its view that objective response rates may not translate to survival benefits.
Given the limited treatment options for late-stage colorectal cancer and the promising survival data from the Phase I trial of botensilimab plus balstilimab (bot/bal), William Blair notes that replicating these Phase 1 results in the Phase 2 ...