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Horizon (HZNP) Gets Positive CHMP Opinion for Uplizna in NMOSD

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Horizon Therapeutics Public Limited Company (HZNP - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to Uplizna (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder (“NMOSD”) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).

The opinion will now be reviewed by the European Commission, which has already granted orphan designation to Uplizna for the given indication.

The positive CHMP opinion was based on data from the N-MOmentum program. Data from the program showed that treatment with Uplizna as a monotherapy reduces the risk of relapse by 77% versus placebo in AQP4-IgG+NMOSD adult patients.

Shares of Horizon have rallied 50.2% so far this year against the industry’s decline of 13.9%.

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We note that in June 2020, the FDA approved Uplizna for adult patients with AQP4-IgG+ NMOSD in order to reduce the risk of attacks. Uplizna is also approved in Japan for the same indication.

Per the company, it is the only approved NMOSD therapy to demonstrate a clinically relevant and durable effect on delaying worsening of disability, with a significant reduction in hospitalization in the United States.

The FDA has granted a Breakthrough Therapy and Orphan Drug designation to Uplizna. The drug generated sales worth $18.7 million in the third quarter of 2021.

Several studies on Uplizna are currently ongoing for different indications.

Horizon is currently evaluating Uplizna in a placebo-controlled phase III study for treating patients with myasthenia gravis, a chronic, rare, autoimmune neuromuscular disease. Another phase III study is investigating Uplizna in patients with IgG4-related disease.

A potential label expansion for any of the above indications should boost Uplizna sales in the days ahead.

Zacks Rank & Stocks to Consider

Horizon currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Galera Therapeutics, Inc. (GRTX - Free Report) , vTv Therapeutics Inc. (VTVT - Free Report) and Editas Medicine, Inc. (EDIT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Galera Therapeutics’ loss per share estimates have narrowed 19.5% for 2021 and 32.3% for 2022, over the past 60 days.

Earnings of Galera Therapeutics have surpassed estimates in only one of the trailing four quarters, and missed the same on the other three occasions.

vTv Therapeutics’ loss per share estimates have narrowed 21.7% for 2021 and 2.9% for 2022, over the past 60 days.

vTv Therapeutics’ earnings have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

Editas Medicine’s loss per share estimates have narrowed 11.9% for 2021 and 4.1% for 2022, over the past 60 days.

Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.