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Novartis' (NVS) Ligelizumab Gets Breakthrough Therapy Status

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Novartis AG (NVS - Free Report) announced that the FDA has granted ligelizumab (QGE031) the Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU), in patients who have an inadequate response to H1-antihistamine treatment.

The FDA’s Breakthrough Therapy tag is granted to expedite development and review of drugs that target serious or life-threatening conditions and show potential substantial improvement over existing therapies on one or more significant clinical endpoints.

Shares of the company declined 0.5% against the industry’s growth of 3% in the past year.

CSU,also known as chronic idiopathic urticaria (CIU),is a distressing and unpredictable skin condition with many patients having uncontrolled symptoms.

Ligelizumab (QGE031) is a next-generation monoclonal anti-immunoglobulin E (IgE) antibody and it is thought to work by blocking the IgE/FcεRI pathway, a key driver of the inflammatory process in CSU.

In January 2020,Novartis announced a mechanistic study results which showed that ligelizumab demonstrated higher effectiveness at inhibiting the major pathogenic IgE/FcεRI pathway in chronic spontaneous urticaria and can bind to IgE with an 88-fold higher affinity than Xolair, which Novartis markets together with Roche AG (RHHBY - Free Report) . The data showedthat ligelizumab and Xolair recognize and bind differently to IgE, with ligelizumab resulting in a significantly enhanced blockade of IgE/FcεRIsignaling.

Ligelizumab compared with Xolair is currently being evaluated in an ongoing phase III program,, which includes phase III studies — PEARL 1 and PEARL 2. The studies have recruited more than 2,000 patients globally across 48 countries and results are expected in the second half of 2021.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the healthcare sector include Alkermes Plc. (ALKS - Free Report) and Halozyme Therapeutics Inc. (HALO - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings per share estimates have increased from 85 cents to 92 cents for 2020 and from $1.68 to $1.72 for 2021 over the past 60 days.

Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 12.9% in the past year.

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