Novo Nordisk A/S shares soared the most in 12 years after the drugmaker said it will resubmit its Tresiba insulin to U.S. regulators, putting the medicine a step closer to approval in the world’s biggest pharmaceutical market.
Novo said Thursday after European markets closed that it will resubmit Tresiba to the Food and Drug Administration within the next month. The Danish company, the world’s largest insulin maker, is acting on an early analysis of a study of the long-acting insulin’s cardiovascular risks.
The shares rose as much as 14 percent, the biggest gain since 2002, as analysts at Goldman Sachs and Morgan Stanley raised their price predictions. The stock was up 10 percent at 368.50 kroner at 9:20 a.m. in Copenhagen.
The decision to move forward in the U.S. “removes long-term growth uncertainty around Novo’s insulin portfolio,” Keyur Parekh, an analyst at Goldman Sachs, said in a note to investors. Parekh raised his price target to 375 kroner from 345 kroner.
The FDA rejected Tresiba in 2013 over concerns that it increased heart problems, a setback to the Bagsvaerd, Denmark-based company in its contest with Sanofi to dominate the diabetes market. Tresiba is already sold in countries including Denmark, the U.K., Switzerland, Sweden, Mexico and Japan. The heart study, dubbed DEVOTE, is expected to be completed in the second half of 2016, Novo said.
“Given Novo’s previous comments, this decision suggests the data as it stands does not suggest a raised cardiovascular risk,” said Sam Fazeli, an analyst with Bloomberg Intelligence. “This means a possible launch in the U.S. in 2016.”
Novo needs Tresiba to wrest market share from Paris-based Sanofi’s best-selling diabetes treatment, Lantus insulin, and its successor product Toujeo, soon to be introduced in the U.S. Novo’s older insulin, Levemir, has trailed Lantus over the years. The Sanofi product garnered 6.34 billion euros ($6.91 billion) in sales last year.
The decision to resubmit Tresiba in the U.S. is a “slight negative” for Sanofi now, and the outcome will be an important determinant of Novo’s ability to compete with the French drugmaker, analysts at Morgan Stanley said in a note. They raised their price target to 358 kroner from 310 kroner.
Sanofi shares were little changed at 91.33 euros as of 9:28 a.m. in Paris.
Long-acting insulins seek to replicate the steady stream of the hormone that healthy people’s bodies produce over 24 hours.