Agenus Inc. (NASDAQ: AGEN), suffered a dramatic drop in its stock price Thursday, with a fall of more than 50%. This was due to the US Food and Drug Administration’s (FDA) decision not to pursue accelerated approval for BOT/BAL, a colorectal cancer combo therapy.
Despite this setback, the company is committed to exploring other pathways to bring the promising treatment to the market.
The FDA’s recommendation was made after Agenus presented its Phase 2 results, which revealed a 19.4% ORR and a 90% survival rate at 6 months for the 75mg dose of BOT/BAL.
Agenus’ stock price plummeted after concerns about the survival benefits of the therapy. The stock had risen significantly earlier in the year.
Dr. Steven O’Day (Agenus’ chief Medical Officer) stressed the company’s commitment to BOT/BAL and plans to include a BOT monotherapy in its upcoming phase 3 trial.
This strategic move is intended to address FDA concerns, and pave a way for future regulatory approval.
Financial and Analyst Insights
Analysts had previously projected a bullish future for Agenus despite the recent stock decline. They gave it a consensus “buy”, and a price target of an average $39 per share.
The company’s financial strength, including the fact that it ended the first quarter with $52.9 millions in cash, demonstrates its ability to navigate regulatory hurdles while advancing its clinical development pipeline.
Agenus to meet European regulators
Agenus is planning strategic engagements with European regulators to discuss regulatory pathways in the third quarter 2024.
The company will also present compelling data about the therapy’s effectiveness in treating Sarcoma in a prestigious European medical event in September. This will highlight its commitment to meeting unmet medical needs.
Agenus is at a critical point in its efforts to balance scientific innovation and regulatory scrutiny.
Agenus is committed to delivering innovative treatments that could potentially transform patient outcomes.
This post Agenus stock plummets more than 50% as FDA rejects accelerated approval of BOT/BAL Cancer Therapy may be modified as new developments unfold
This site is for entertainment only. Click here to read more
