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Roche (RHHBY) Announces Positive Data on Hemophilia A Drug

Roche Holdings AG RHHBY announced positive data from the phase III study, HAVEN 1, on hemophilia A candidate emicizumab. The data were published in The New England Journal of Medicine (NEJM).

The study evaluated once-weekly subcutaneous emicizumab prophylaxis (preventative) in adults and adolescents with hemophilia A with inhibitors. The primary endpoint showed a clinically meaningful and statistically significant reduction in treated bleeds of 87% with emicizumab prophylaxis compared to on-demand bypassing agents (BPAs). In addition, all 12 secondary endpoints were positive, including a statistically significant reduction of 79% in treated bleeds in a subset of patients comparing two prophylaxis regimens (emicizumab and BPAs).

The data from the study, HAVEN 1 as well as the interim analysis of the phase III study, HAVEN 2, of emicizumab in children will be presented at the 26th International Society on Thrombosis and Haemostasis (ISTH) Congress.

The data from both studies have been submitted to the FDA and the EMA for approval. We remind investors that the FDA granted Breakthrough Therapy Designation for emicizumab in adults and adolescents with hemophilia A with inhibitors in Sep 2015.

Meanwhile, Roche is evaluating emicizumab in patients with hemophilia A both with and without inhibitors and evaluating less frequent dosing regimens as well.

Roche’s share price shows that the company has underperformed the Zacks classified industry in the last year. The stock lost 4.6% compared with the Large Cap Pharmaceuticals industry’s gain of 1.2%.

Along with emicizumab, Roche’s hematology portfolio at present consists of MabThera/Rituxan, Gazyva/Gazyvaro and VenclextaTM/VenclyxtoTM in collaboration with AbbVie ABBV along with a pipeline which has a small molecule antagonist of MDM2 (idasanutlin/RG7388) and polatuzumab vedotin.

A few other companies are also developing treatments for hemophilia A. Last week, Shire SHPG filed an investigational new drug (IND) application with the FDA, seeking approval for recombinant factor VIII (FVIII) gene therapy candidate, SHP654. The drug will be used for the treatment of patients with hemophilia A.

Zacks Rank and Stock to Consider

Roche currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the health care sector is Enzo Biochem, Inc. ENZ , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Enzo Biochem’s loss estimates have narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018 over the last 30 days. The company delivered positive earnings surprise in the last four quarters, with an average beat of 55.83%. Its shares have moved up 59.9% so far this year.

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Roche Holding AG (RHHBY): Free Stock Analysis Report
AbbVie Inc. (ABBV): Free Stock Analysis Report
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Shire PLC (SHPG): Free Stock Analysis Report
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