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Novo Nordisk (NVO) Resumes Phase III Hemophilia Studies

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Novo Nordisk (NVO - Free Report) 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 - Free Report) , Horizon Therapeutics Public Limited Company (HZNP - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) . 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.

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