63% Drop in Pre-Market Trading Following FDA’s Disapproval

  • Agenus shares drop after FDA discourages accelerated approval for colon cancer treatment
  • Stock down 63% in premarket trading
  • Company cites objective response rates not translating to survival benefit
  • Phase 2 trial results not sufficient for accelerated approval
  • Agreement on Phase 3 trial dosing with FDA
  • FDA recommends monotherapy of botensilimab for next study

Agenus shares plunged after the company announced that the Food and Drug Administration (FDA) advised against seeking accelerated approval for its immunotherapy combination of botensilimab and balstilimab as a treatment for adult patients with relapsed and refractory microsatellite stable colorectal cancer. The stock fell 63% to $6.50 in premarket trading, down from its year-to-date gain of 7%. Agenus revealed that objective response rates in a Phase 2 trial did not demonstrate a clear survival benefit. However, the company and FDA have agreed on dosing for a Phase 3 trial of the combination therapy and suggested testing monotherapy of botensilimab in the next study.

Factuality Level: 8
Factuality Justification: The article provides accurate and objective information about the FDA’s advice to Agenus regarding their trial results and future plans for Phase 3 trials, with no signs of sensationalism or personal opinion.
Noise Level: 2
Noise Justification: The article provides relevant and concise information about the FDA’s decision on Agenus’s trial results and its impact on the company’s stock price, as well as the next steps for the Phase 3 trial. It does not contain any irrelevant or misleading information, nor does it reinforce popular narratives without questioning them. However, it lacks analysis of long-term trends or possibilities, accountability, scientific rigor and intellectual honesty, staying on topic, evidence, data, examples, or actionable insights.
Public Companies: Agenus (AGEN)
Key People: Dean Seal (Author)

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Financial Relevance: Yes
Financial Markets Impacted: Agenus stock
Financial Rating Justification: The article discusses the impact of regulatory advice on Agenus’s stock price and future clinical trials, which directly affects the company’s financial situation and investor sentiment.
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Extreme Rating Justification: No extreme event mentioned in the article

Reported publicly: www.marketwatch.com