Novo Nordisk NVO announced that the phase III studies (explorer 6, 7 and 8) on concizumab are being resumed. The studies are investigating subcutaneous concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status.
In March 2020, Novo Nordisk paused two clinical studies in the concizumab phase III program (explorer 7 and 8) and one clinical trial in the phase II program (explorer 5). Consequently, no additional patients we recruited and further treatment of patients enrolled in the studies was ceased.
The decision was a result of the occurrence of non-fatal thrombotic events in three patients enrolled in the ongoing phase III program.
Novo Nordisk together with relevant authorities identified a new path forward for concizumab. New safety measures and guidelines, based on analysis of all available data, have been agreed on with the FDA and the clinical hold has been lifted.
Shares of the company have gained 15.5% compared with the industry’s growth of 1.0%.
In October 2019, Novo Nordisk initiated the explorer 7 phase III study with concizumab in patients with hemophilia A or B with inhibitors toward FVIII or FIX. The objective of the study was to establish the safety and efficacy of once-daily prophylactic subcutaneous concizumab delivered in a pen device to reduce the number of bleeds. A parallel phase III study, explorer 8, in hemophilia A or B patients without inhibitors was initiated in November 2019.
Novo Nordisk has a strong presence in the Diabetes care market with one of the broadest diabetes portfolios in the industry. Moreover, it is encouraging to see the company’s efforts to develop new treatments. In February 2019, the FDA approved Novo Nordisk’s biologics license application (BLA) for Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of hemophilia A in adults and children. The drug is approved for the routine prophylactic to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes plus perioperative management of bleeding in the given patient population
Zacks Rank &Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and Alimera Sciences Inc. ALIM. While Emergent and Horizon Therapeutics sport a Zacks Rank #1 (Strong Buy), Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $4.03 to $5.60 for 2020 and from $3.73 to $6.67 for 2021 over the past 60 days.
Horizon Therapeutics’ earnings estimates have increased from $1.54 to $2.68 for 2020 and from $2.71 to $4.34 for 2021 over the past 60 days.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days.
Today’s Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through Q2 2020, while the S&P 500 gained an impressive +44.0%, five of our strategies returned +50.9%, +93.8%, +122.2%, +153.0%, and even +156.8%. This outperformance has not just been a recent phenomenon. From 2000 – Q2 2020, while the S&P averaged +5.5% per year, our top strategies averaged up to +51.7% per year.
See their latest picks free >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Zacks Investment Research
