US regulator FDA (Food and Drug Administration) has denied approval for Novo Nordisk's insulin Tresiba due to the need for more data that assesses heart risk.

Shares in the Danish company tanks on Monday morning after it admitted that it is unlikely it will be able to provide the requested information this year.

Novo Nordisk has been working on the long-acting insulin for type 1 diabetics to compete with rival Sanofi's Lantus product.

In a note published after the news came out, analysts at Jefferies commented that they expect Sanofi to benefit the most and they indicated that the decision could result in up to a five-year delay for Novo Nordisk product's approval in the US.

The brokers downgraded the Danish stock to 'hold' on November 6th due precisely to their caution on the outcome of this issue due to "the negative stance from the FDA itself" back when the briefing documents were published.

Jefferies maintained its 'hold' recommendation and a 960 kroner price target.

Novo Nordisk plummeted 11.92% to 942.50 kroner on Monday morning.

JM

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