Agenus Inc. got an unwelcome surprise from the US Food and Drug Administration as the agency recommended against the company filing for accelerated approval for the combination of its CTLA-4-targeting monoclonal antibody botensilimab and the PD-1-targeting balstilimab (BOT/BAL) in relapsed/refractory microsatellite-stable colorectal cancer (MSS CRC) with no active liver metastases.
FDA Leaves Door Open For Further Discussions With Agenus Over BOT/BAL
The biotech company surprised observers when it announced the agency advised against filing for accelerated approval of the CTLA-4/PD-1 combination.
More from Strategy
• By
European pharma leaders want to see a deal so that no tariffs are imposed on medicines – but they also want the European Union to urgently rethink its sector policies that they believe will lead to massive investment loss.
• By
The US president's most recent comments suggest tariffs on pharma are imminent and Ireland has the most to lose.
• By
As drugmakers update investors on first quarter financial performance, uncertainty around global trade and US regulatory oversight is likely to dominate discussions.
• By
Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
More from Business
• By
Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
• By
The biotech has rejected a takeover bid from Nordic Capital but a sale to private equity could be a solution to the public market's continued reluctance to adequately value PureTech’s hub-and-spoke business model.
• By
There were six biopharma initial public offerings on Western stock exchanges, including five in the US, during the first quarter, but plunging stock values could halt further IPOs.