Sunday, March 3, 2013

Novo Nordisk shares plunge on FDA rejection

LOS ANGELES (MarketWatch) � Shares of Novo Nordisk plunged 14% Monday after the company suffered a setback for its planned launch of new insulin products as the U.S. Food and Drug Administration asked for further testing on the treatments.

Danish-based Novo Nordisk NVO �DK:NOVOB �also fell more than 14% in European trading after the FDA declined approval for Tresiba and a related product known as Ryzodeg.

Reuters Enlarge Image Novo Nordisk�s corporate headquarters

In a news release, the company said the FDA is seeking additional cardiovascular data. Novo Nordisk does not expect to be able to complete the data this year.

The company said, however, that it does not expect the news to affect financial results for the year. Analysts polled by FactSet are calling for Novo Nordisk to earn $8.38 a share for the year.

Shares ended trading down $26.89 to $166.40.

Regeneron Pharmaceuticals Inc. REGN �jumped as much as 8% after the company said that French drug maker Sanofi SA SNY �filed Hart-Scott-Rodino antitrust papers and plans to acquire more shares of the company.

Click to Play Too much cheering over stocks

Stock market cheerleaders may be running onto the field, but sidelines are safer and only slightly less attractive these days. Photo: Getty Images.

Sanofi plans to hold at least $500 million worth of stock when the purchases are complete, Regeneron said, and will do so through open market buys and direct purchases.

Shares of Regeneron were halted at the opening bell and didn�t resume trading until 10:05 a.m. Eastern.

Sanofi issued a statement, saying it is bound by a 2007 agreement to not acquire more than 30% of Regeneron shares.

The statement said: �Sanofi needed to file as we could not buy any share without filing for [Hart-Scott-Rodino]. We are very happy with the relationship with Regeneron, but needed this technical filing to get freedom to operate.�

It went on to say: �Sanofi has the right to increase its shareholding in Regeneron. It may increase its holding over time subject to market conditions and within the terms of our partnership agreement. Sanofi has not announced any intention to take a controlling stake in Regeneron.�

Regeneron ended the day up 2.7% to $170.35. Sanofi was up more than 3% to $48.01. Analysts said that the FDA�s rejection of Novo Nordisk�s insulin drugs could help Sanofi�s Lantus, a competing medication.

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