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Novo Nordisk Files Regulatory Application for Semaglutide
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Novo Nordisk A/S (NVO - Free Report) announced that it has submitted a regulatory application for its glucagon-like peptide-1 (GLP-1) analogue, semaglutide (once-weekly), in both the U.S. and the EU for the treatment of adults with type II diabetes.
A look at the company’s share price movement so far this year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. The stock’s price declined 40.7% in the year-to-date period, which compared unfavorably to the 8.4% fall for the industry.
Coming back to the latest news, the submission was based on results from the SUSTAIN phase IIIa clinical trial program, which evaluated semaglutide (once-weekly) in combination with oral-antidiabetic agents and basal insulin. Findings demonstrated statistically significant and sustained blood glucose control in patients treated with semaglutide in comparison to sitagliptin, exenatide extended-release, Sanofi’s (SNY - Free Report) Lantus (insulin glargine U100/once-daily) and placebo.
Novo Nordisk plans to deliver semaglutide in the prefilled delivery device, FlexTouch. A potential approval in the U.S. and the EU will further strengthen Novo Nordisk’s diabetes portfolio. We note that the company has a strong presence in the Diabetes Care market, supported by one of the broadest diabetes portfolios in the industry comprising drugs like Victoza, Levemir and modern insulins.
The company expects sales to grow 5–6% in 2016, driven by continually strong performance of modern insulins Tresiba and Victoza as well as contributions from Saxenda and Xultophy.
We remind investors that last month, Xultophy 100/3.6 was approved in the U.S. in adjunct to diet and exercise for improving glycemic control in adults with type II diabetes mellitus, inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).
Note that the market for diabetes is highly crowded. Although Novo Nordisk is the market leader with a global value share of 27%, loss of exclusivity for products like NovoRapid/NovoLog and NovoLog Mix/NovoMix, along with intensifying competition in the diabetes market, will affect the company’s top line.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 6.5% year to date.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates have increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average positive surprise of 56.65%. Its share price has surged 67.5% year to date.
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Novo Nordisk Files Regulatory Application for Semaglutide
Novo Nordisk A/S (NVO - Free Report) announced that it has submitted a regulatory application for its glucagon-like peptide-1 (GLP-1) analogue, semaglutide (once-weekly), in both the U.S. and the EU for the treatment of adults with type II diabetes.
A look at the company’s share price movement so far this year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. The stock’s price declined 40.7% in the year-to-date period, which compared unfavorably to the 8.4% fall for the industry.
Coming back to the latest news, the submission was based on results from the SUSTAIN phase IIIa clinical trial program, which evaluated semaglutide (once-weekly) in combination with oral-antidiabetic agents and basal insulin. Findings demonstrated statistically significant and sustained blood glucose control in patients treated with semaglutide in comparison to sitagliptin, exenatide extended-release, Sanofi’s (SNY - Free Report) Lantus (insulin glargine U100/once-daily) and placebo.
Novo Nordisk plans to deliver semaglutide in the prefilled delivery device, FlexTouch. A potential approval in the U.S. and the EU will further strengthen Novo Nordisk’s diabetes portfolio. We note that the company has a strong presence in the Diabetes Care market, supported by one of the broadest diabetes portfolios in the industry comprising drugs like Victoza, Levemir and modern insulins.
The company expects sales to grow 5–6% in 2016, driven by continually strong performance of modern insulins Tresiba and Victoza as well as contributions from Saxenda and Xultophy.
We remind investors that last month, Xultophy 100/3.6 was approved in the U.S. in adjunct to diet and exercise for improving glycemic control in adults with type II diabetes mellitus, inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).
Note that the market for diabetes is highly crowded. Although Novo Nordisk is the market leader with a global value share of 27%, loss of exclusivity for products like NovoRapid/NovoLog and NovoLog Mix/NovoMix, along with intensifying competition in the diabetes market, will affect the company’s top line.
NOVO-NORDISK AS Price and Consensus
NOVO-NORDISK AS Price and Consensus | NOVO-NORDISK AS Quote
Novo Nordisk currently has Zacks Rank #4 (Sell).
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector include Cambrex Corporation and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 6.5% year to date.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates have increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average positive surprise of 56.65%. Its share price has surged 67.5% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>