Novo Nordisk (NVO - Free Report) announced that the FDA has approved its fast-acting mealtime insulin aspart, Fiasp, for the treatment of adults with diabetes.
The FDA approval was based on results from a phase III study showing that Fiasp improved overall blood sugar (HbA1c) and post-meal sugar (postprandial glucose or PPG) control over 52 weeks compared with conventional insulin aspart (NovoRapid).
The company had resubmitted the new drug application (NDA) for Fiasp as a class II re-submission to the FDA in March 2017.
In October 2016, Novo Nordisk announced that it had received a Complete Response Letter from the FDA regarding the NDA for fast-acting insulin aspart. In the letter, the FDA requested additional information related to the assay for the immunogenicity and the assay used to generate the clinical pharmacokinetics data before the review of the NDA could be completed.
Novo Nordisk’s shares have outperformed the industry year to date. The stock has rallied 36.7% compared with the industry’s gain of 16.5% in the same time frame.
Fiasp is already approved in Europe for improving the control of postprandial glucose (PPG) excursions in patients with type I and type II diabetes as well as for pump treatment.
In fact, the company has a strong presence in the diabetes care market with a global value market share of 27%. Also, the company has strong presence in the total insulin market, and modern and new-generation insulin market with a global value market share of 46% and 45%, respectively. Notably, Novo Nordisk has one of the broadest diabetes portfolios in the industry.
Zacks Rank & Stocks to Consider
Novo Nordisk carries a Zacks Rank #3 (Hold). Some better-ranked stocks in health care sector include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Biogen Inc. (BIIB - Free Report) and Aduro BioTech, Inc. (ADRO - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Biogen and Aduro carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have increased from $13.84 to $14.99 for 2017 and from $15.79 to $16.65 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 21.8% year to date.
Biogen’s earnings per share estimates have moved up $21.37 to $21.42 for 2017 and from $23.11 to $23.23 for 2017 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 6.41%. The share price of the company has increased 10.3% year to date.
Aduro’s loss estimates per share have narrowed from $1.36 to $1.29 for 2017 over last 60 days. The company came up with positive earnings surprises in two of the trailing four quarters, with an average beat of 2.53%.
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