AstraZeneca (AZN - Free Report) and its global biologics research and development arm, MedImmune announced disappointing top-line results from the TULIP 1 phase III study for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The phase III study did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE, as measured by the SLE Responder Index 4 (SRI4) at 12 months.
Anifrolumab is a developmental mAb that inhibits the activity of all type I interferons (IFN), which play a central role in lupus. SLE is a chronic autoimmune disease with significant unmet need.
The TULIP study includes two phase III clinical studies, TULIP 1 and TULIP 2, which are evaluating the efficacy and safety of anifrolumab compared with placebo in patients with moderately-to-severely active autoantibody-positive SLE who are receiving standard of care treatment.
Further, anifrolumab is also being tested in a phase III SLE long-term extension study, a phase II study using subcutaneous delivery in SLE and a phase II study for lupus nephritis.
Shares of the company have increased 10.5% year to date compared with the industry’s growth of 4.6%.
There are very few medicines approved for SLE. Per GlaxoSmithKline plc (GSK - Free Report) , its human monoclonal antibody, Benlysta (belimumab) is currently the only medicine specifically developed and approved for SLE. In March 2018, GlaxoSmithKlineinitiated 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 SLE. The main aim of the study is to evaluate whether the combination treatment achieves a state of low disease activity along with clinical remission in patients living with this chronic and unpredictable disease.
Zacks Rank & Stock to Consider
AstraZeneca has a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Gilead Sciences Inc. (GILD - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 5.7% so far this year.
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