Shares of Novo Nordisk tumbled Monday after the Danish drugmaker said U.S. regulators want to see a new study before they can finish their review of two diabetes treatments with a long-acting insulin.
The company said Sunday that the Food and Drug Administration requested information from a study that looks at cardiovascular health before it makes a decision on Tresiba and Ryzodeg, which both use the insulin degludec.
Novo Nordisk said it was surprised and disappointed by the decision. The company plans to provide the requested data, but it probably will not be able to do so this year. The request could delay U.S. approval by up to five years, Jefferies analyst Jeffrey Holford said in a research note.