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Roche's Hemophilia A Drug Positive in Second Phase III Study

Zacks Equity Research

Roche Holding AG’s RHHBY unit Genentech announced positive interim results from the Phase III HAVEN 2 study evaluating its pipeline candidate emicizumab prophylaxis. Emicizumab was being assessed 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.

Roche’s share price shows that the company has outperformed the Zacks classified industry year to date. The stock rallied 11.8% compared with the Large Cap Pharmaceuticals industry’s gain of 5.4% during the period.

Notably, the results were in line with data from the phase III HAVEN 1 study in adults and adolescents (12 years of age or older) for the same indication.  The data from the study announced in Dec 2016 showed a statistically significant reduction in the number of bleeds over time in patients treated with emicizumab prophylaxis as compared to those patients who do not receive prophylactic treatment.

Going forward, data from both HAVEN 1 and the interim results from HAVEN 2 studies will be presented at an upcoming medical meeting and submitted toregulatory authorities in order to get an approval.

Roche has been in the news this month for data-readouts and regulatory updates.

Last week, Roche announced that the global randomized phase III study, ALEX, on lung cancer drug Alecensa met its primary endpoint as an initial (first-line) treatment. According to the evaluation, Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with Pfizer’s PFE Xalkori in patients suffering from anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Also, earlier this month, Roche announced encouraging results from another phase III study, ALUR Alecensa. This study also met its primary endpoint as data from the study demonstrated that Alecensa significantly improved progression-free survival (PFS) in patients. Importantly, last month, Roche received FDA approval for its highly-awaited multiple sclerosis (MS) drug, Ocrevus, which is expected to have blockbuster potential.

Roche Holding AG Price


Roche Holding AG Price | Roche Holding AG Quote

Zacks Rank & Key Picks

Roche currently sports a Zacks Rank #1 (Strong Buy). Other top-ranked stocks in the health care sector include Heska Corp. HSKA and Galena Biopharma, Inc. GALE. Both the companies carry Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates moved up from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 60 days. The company posted a positive earnings surprise in all of the last four quarters, with an average beat of 291.54%. Its share price increased 41.9% year to date.

Galena Biopharma‘s loss estimates narrowed from $2.27 to 58 cents for 2017 and from 92 cents to 73 cents for 2018, over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 53.83%.  

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