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AstraZeneca's COPD Candidate Duaklir Reports Positive Data

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AstraZeneca Plc (AZN - Free Report) announced positive top-line results from the phase III AMPLIFY study for Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily). The candidate is being evaluated for the treatment of chronic obstructive pulmonary disease (COPD).

The study met its primary endpoint and showed a statistically-significant improvement in lung function in patients with moderate to very severe stable COPD compared to each individual component (either aclidinium bromide or formoterol).  

AstraZeneca’s shares have outperformed the industry year to date. The stock has rallied 11.1% compared with the industry’s gain of 10.2% in the same time frame.

A full evaluation of the AMPLIFY data is ongoing and further results will be presented at a forthcoming medical meeting. AstraZeneca expects to submit an new drug application (NDA)  for Duaklir to the FDA during the first half of 2018 based on the AMPLIFY data.

In April, the company entered a strategic collaboration with Circassia Pharmaceuticals PLC for the development and commercialization of COPD drugs Tudorza and Duaklir in the United States.

In a separate release, AstraZeneca along with partner Amgen Inc. (AMGN - Free Report) also announced results from the PATHWAY phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by MedImmune.

 

Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) both sporting a Zacks Rank #1 (Strong Buy).  You can see the complete list of today’s Zacks #1 Rank stocks here.

Alexion Pharmaceuticals’ earnings per share estimates have moved up from $5.32 to $5.61 for 2017 and from $6.53 to $6.92 for 2018 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 11.12%. The share price of the company has increased 18.7% year to date.

Regeneron’s earnings per share estimates have increased from $12.86 to $14.99 for 2017 and from $15.52 to $16.49 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 36.2% year to date.

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