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AstraZeneca's (AZN) Calquence Fails in Coronavirus Study

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AstraZeneca PLC (AZN - Free Report) announced that its BTK inhibitor drug Calquence (acalabrutinib) did not meet the primary efficacy endpoint in the phase II CALAVI study, which evaluated the same for treating patients hospitalized with respiratory symptoms of COVID-19.

Data from the CALAVI study showed that Calquence when added to the best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. However, the safety and tolerability profile of Calquence was similar to what was observed in the previous studies for the given patient population.

The CALAVI study comprised two phase II studies, which evaluated the combination of Calquence plus BSC compared to BSC alone for patients hospitalized with COVID-19 infection.

Notably, in April 2020, AstraZeneca announced plans to initiate the CALAVI study as preclinical and early clinical data on Calquence demonstrated its potential to treat the exaggerated immune response (cytokine storm) in patients hospitalized with COVID-19 infection.

We note that Calquence is approved to address previously treated mantle cell lymphoma and chronic lymphocytic leukemia indication (in frontline as well as relapsed/recurrent disease setting). The drug generated sales of $340 million in the first nine months of 2020.

Shares of AstraZeneca have rallied 16.4% year to date compared with the industry’s increase of 0.6%.

price chart for AstraZeneca


AstraZeneca is evaluating its COVID-19 vaccine candidate AZD1222 in partnership with the Oxford University. Last week, the company resumed its late-stage clinical studies on AZD1222 in the United States after those were paused in September due to an unexplained illness.

Also, in October 2020, AstraZeneca announced that it plans to start two phase III studies shortly on AZD7442, its investigational cocktail antibody therapy, which is being developed for the prevention and treatment of COVID-19. AZD7442 is a combo of two monoclonal antibodies, namely AZD8895 and AZD1061.

We note that apart from AstraZeneca, companies like Johnson & Johnson (JNJ - Free Report) , Moderna (MRNA - Free Report) , Pfizer (PFE - Free Report) /BioNTech are developing their respective COVID-19 vaccine candidates in late-stage clinical studies.

Earlier this week, Pfizer/BioNTech announced the first interim data from a phase III study on their mRNA-based coronavirus vaccine candidate BNT162b2. Data from the same showed that the candidate was more than 90% effective in preventing COVID-19 in participants without any evidence of prior SARS-CoV-2 infection.

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AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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