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Global Blood's (GBT) Oxbryta Secures FDA Approval for SCD

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Global Blood Therapeutics, Inc. (GBT - Free Report) announced that the FDA has approved its lead product candidate Oxbryta (voxelotor) as an oral, once-daily treatment for sickle cell disease (SCD) in patients aged 12 years and above. The approval comes almost three months ahead of the scheduled action date of Feb 26, 2020.

SCD is a chronic, inherited blood disorder that affects hemoglobin levels.

Following this nod, Oxbryta became the first approved therapy that directly inhibits sickle hemoglobin polymerization, a major cause for SCD.

Shares of Global Blood have surged 53.4% so far this year compared with the industry’s rise of 4.6%.

Meanwhile, the company is on track to initiate a post-approval confirmatory study (HOPE-KIDS 2) by this year-end on Oxbryta using transcranial doppler (TCD) flow velocity to show a reduction in stroke risk among children aged from two to 15 years.

Importantly, treatment options are limited for SCD. However, Global Blood is likely to face stiff competition as many companies are developing therapies to treat the disease.

In November 2019, the FDA approved Novartis’ (NVS - Free Report) Adakveo (crizanlizumab) to lower the frequency of vaso-occlusive crises (VOCs) or pain crises in patients with SCD, aged 16 years or above. The nod came approximately two months ahead of the FDA’s priority-review action date.

bluebird bio (BLUE - Free Report) is also developing a LentiGlobin for the treatment of VOC in patients with SCD.

Zacks Rank & Key Pick

Global Blood currently has a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have been revised 16% upward for 2019 and 17.4% for 2020 over the past 60 days. The stock has rallied 71.4% so far this year.

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