The drugs have been slow to catch on since approval more than two years ago, but results showing reduction in cardiovascular events could help it gain traction.

Deal Snapshot: Akeso has already sought to secure FDA approval for its PD-1 inhibitor, but the agency has shown reluctance to approve drugs based on China-only data.

The drug is dosed once every four weeks – compared with Mounjaro and Wegovy’s weekly dosing – but the company also signaled it is considering extended dosing intervals.

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.

The microbiome therapy won approval for preventing recurrence of Clostridioides difficile infections, but an analyst said the future could be in more targeted approaches.

Without disclosing data, Nimbus announced positive Phase IIb results for NDI-034858 in psoriasis. The company plans to initiate a Phase III trial next year.