Agenus Inc 
AGEN confronted a dramatic decline in its inventory value on Thursday, plummeting greater than 50%, following the US Meals and Drug Administration (FDA’s) choice to advise in opposition to pursuing accelerated approval for its BOT/BAL colorectal most cancers mixture remedy.
Regardless of the setback, the corporate stays dedicated to exploring various pathways to convey this promising therapy to market.
The FDA’s suggestion got here after Agenus introduced outcomes from its Part 2 examine, revealing a 19.4% total response price (ORR) and a 90% 6-month survival price for the 75mg dosage of BOT/BAL.
Nevertheless, issues concerning the remedy’s survival advantages led to a pointy sell-off of Agenus inventory, which had seen important positive factors earlier within the yr.
Dr. Steven O’Day, Agenus’ chief medical officer, emphasised the corporate’s willpower to advance BOT/BAL, together with plans to include a BOT monotherapy arm in its upcoming Part 3 trial.
This strategic transfer goals to handle FDA issues and pave the best way for future regulatory approval.
Monetary and analyst insights
Regardless of the inventory’s latest downturn, analysts beforehand projected a bullish outlook for Agenus, with a consensus “purchase” ranking and a median value goal of $39 per share.
The corporate’s monetary resilience, together with ending the primary quarter with $52.9 million in money, underscores its potential to navigate regulatory challenges whereas advancing its medical pipeline.
Agenus to fulfill with European regulators
Wanting forward, Agenus plans strategic engagements with European regulators within the third quarter of 2024 to debate regulatory pathways for BOT/BAL.
Moreover, the corporate will current compelling knowledge on the remedy’s efficacy in treating Sarcoma at a prestigious European medical oncology occasion in September, highlighting its dedication to addressing unmet medical wants.
The FDA’s choice represents a essential juncture for Agenus because it strives to steadiness scientific innovation with regulatory scrutiny.
Whereas the setback underscores the challenges inherent in drug growth, Agenus stays steadfast in its mission to ship progressive therapies that may probably rework affected person outcomes in oncology.
