Agenus Inc (NASDAQ: AGEN) faced a dramatic decline in its stock price on Thursday, plummeting more than 50%, following the US Food and Drug Administration (FDA’s) decision to advise against pursuing accelerated approval for its BOT/BAL colorectal cancer combination therapy.
Despite the setback, the company remains committed to exploring alternative pathways to bring this promising treatment to market.
The FDA’s recommendation came after Agenus presented results from its Phase 2 study, revealing a 19.4% overall response rate (ORR) and a 90% 6-month survival rate for the 75mg dosage of BOT/BAL.
However, concerns about the therapy’s survival benefits led to a sharp sell-off of Agenus stock, which had seen significant gains earlier in the year.
Dr. Steven O’Day, Agenus’ chief medical officer, emphasized the company’s determination to advance BOT/BAL, including plans to incorporate a BOT monotherapy arm in its upcoming Phase 3 trial.
This strategic move aims to address FDA concerns and pave the way for future regulatory approval.
Financial and analyst insights
Despite the stock’s recent downturn, analysts previously projected a bullish outlook for Agenus, with a consensus “buy” rating and an average price target of $39 per share.
The company’s financial resilience, including ending the first quarter with $52.9 million in cash, underscores its ability to navigate regulatory challenges while advancing its clinical pipeline.
Agenus to meet with European regulators
Looking ahead, Agenus plans strategic engagements with European regulators in the third quarter of 2024 to discuss regulatory pathways for BOT/BAL.
Additionally, the company will present compelling data on the therapy’s efficacy in treating Sarcoma at a prestigious European medical oncology event in September, highlighting its commitment to addressing unmet medical needs.
The FDA’s decision represents a critical juncture for Agenus as it strives to balance scientific innovation with regulatory scrutiny.
While the setback underscores the challenges inherent in drug development, Agenus remains steadfast in its mission to deliver innovative treatments that can potentially transform patient outcomes in oncology.
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