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GlaxoSmithKline Initiates Phase III Combo Study on Benlysta

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GlaxoSmithKline plc (GSK - Free Report) initiated a phase III study evaluating human monoclonal antibody — Benlysta (belimumab) — in combination with Roche’s (RHHBY - Free Report) anti-CD20 monoclonal antibody- Rituxan (rituximab) in adult patients with systemic lupus erythematosus (SLE). Benlysta is currently the only medicine specifically developed and approved for SLE.

The study named BLISS-BELIEVE will evaluate the efficacy and safety of Benlysta administered in combination with a single cycle of Rituxan in patients with SLE. The primary endpoint of the study is disease control defined as Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) -2K score <2, that will be achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of <5 mg/day at week 52. Clinical remission and durable response with no treatment other than antimalarials, are the secondary endpoints. The study is expected to complete in 2021.

The main aim of the study is to evaluate whether the combination treatment will not only achieve a state of low disease activity, but also achieve clinical remission in patients living with this chronic and unpredictable disease.

Over the year, the shares of the company have declined 13.1% against the industry’s gain of 8.3%.

 

 

SLE is a chronic disease and is the most common form of lupus, affecting about 70% percent of an estimated 5 million people with lupus worldwide.

GlaxoSmithKline possesses one of the strongest late-stage pipelines in large-cap pharma. The company is focused on oncology, immuno-inflammation, HIV and respiratory therapeutic areas. The successful development and commercialization of the pipeline candidates should boost the company’s top line.

 

 

Zacks Rank & Key Picks

GlaxoSmithKline carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the same space are Regeneron Pharmaceuticals (REGN - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) . Both Regeneron and Ligand sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

Ligand’s earnings per share estimates have moved up from $3.78 to $4.20 and from $4.75 to $5.32 for 2018 and 2019, respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 61.2% over a year.

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