Novo Nordisk's (NVO) Drug Gets FDA Approval For Hemophilia B

Novo Nordisk (CO:NOVOb) (NYSE:NVO) announced that the FDA has approved the Biologics License Application (BLA) for Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

Novo Nordisk’s share price shows that the company has outperformed the Zacks classified Large Cap Pharmaceuticals industry year to date. The stock rallied 18.2% compared with the industry’s gain of 10.2%.

We note Rebinyn is the brand name for nonacog beta pegol, N9-GP. It The evaluation was based on the results from the paradigm clinical trial program where 115 previously treated children and adults with haemophilia B were treated with Rebinyn, and the approval follows the Blood Products Advisory Committee meeting held on April 4, 2017.

In Mar 2017, the company received a positive opinion from the European authorities on the use of Refixia, the brand name for N9-GP in Europe, recommending marketing authorization for the treatment of adolescents and adults with hemophilia B. The approval should boost the revenues of the company.

We remind investors that in Apr 2017, Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) unit Genentech announced positive interim results from the Phase III HAVEN 2 study evaluating its pipeline candidate emicizumab. Emicizumab is being evaluated in children less than 12 years of age with hemophilia A and inhibitors to factor VIII. The study revealed that emicizumab reduced the number of bleeds in children with hemophilia A and inhibitors to factor VIII after 12 weeks of treatment over time.

Zacks Rank and Key Picks

Novo Nordisk carries a Zacks Rank#3 Hold). Some better ranked stocks in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) and MEI Pharma, Inc. (NASDAQ:MEIP) . Both VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.

MEI Pharma’s estimates narrowed from loss per share of 1 cent to gain per share of 1 cent for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.

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