As last week ended, Eli Lilly disclosed a setback — the US Food and Drug Administration declined to approve its new biologic treatment for rheumatoid arthritis. The news, which was released on a day when the stock market was closed, came as a surprise and sent Lilly shares down nearly 4 percent so far today. And shares in Incyte, which would collect royalties on any sales, are down 10 percent.
The reactions reflect not only disappointment but considerable uncertainty. The reason is the FDA wants more clinical data to determine appropriate dosing as well as to address unspecified safety concerns. Lilly says it “disagree[s] with the agency’s conclusions,” but must now run further studies, and the eventual timing of any regulatory approval is unclear, which, of course, gives competitors a nice edge.