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AstraZeneca's (AZN) Asthma Drug Meets Primary Goal in Phase III

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Zacks Equity Research
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AstraZeneca PLC AZN along with Amgen AMGN announced that their promising pipeline candidate tezepelumab met the primary endpoint in the phase III NAVIGATOR study, which evaluated the candidate for treating patients with severe, uncontrolled asthma.

Data from the study showed that treatment with tezepelumab plus standard of care (SoC) led to a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER), a measure of deterioration of asthma, over 52 weeks of treatment versus placebo plus SoC in the overall patient population.

Moreover, in patients with low levels of eosinophil (less than 300 cells per microlitre and less than 150 cells per microlitre) too, tezepelumab demonstrated a statistically significant and clinically meaningful reduction in AAER. Results from the study will be presented at an upcoming medical conference. Importantly, tezepelumab was well tolerated in patients suffering severe asthma.

Secondary endpoints of the NAVIGATOR study included the effect of tezepelumab on lung function, asthma control and health-related quality of life.

Shares of AstraZeneca have rallied 13.5% so far this year against the industry’s decrease of 0.8%.

Price chart for AstraZeneca
Price chart for AstraZeneca


We note that tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody, currently being evaluated for the treatment of patients with severe, uncontrolled asthma.

In September 2018, the FDA granted a Breakthrough Therapy designation to tezepelumab for the treatment of patients with severe, uncontrolled asthma without an eosinophilic phenotype.

The NAVIGATOR study is part of the phase III PATHFINDER program on tezepelumab. Another study on tezepelumab in the phase III PATHFINDER program is SOURCE.

We note that the asthma market holds great potential. However, upon potential approval, tezepelumab is likely to face stiff competition from treatments like GlaxoSmithKline’s GSK Nucala, which is approved for several indications, anmey severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.

Zacks Rank & Key Pick

AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Repligen Corporation RGEN, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Repligen’s earnings estimates have been revised 7.8% and 10.5% upward for 2020 and 2021 each over the past 60 days. The stock has skyrocketed 102.1% year to date.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report
 
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
 
Amgen Inc. (AMGN) : Free Stock Analysis Report
 
Repligen Corporation (RGEN) : Free Stock Analysis Report
 
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