AstraZeneca plc ( AZN Quick Quote AZN - Free Report) resumed its phase I/II clinical study on its COVID-19 vaccine candidate, AZD1222, in Japan, which it had halted in September. It took the decision after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Last month, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, which it is developing in partnership with Oxford University, as a patient in U.K. suffered an unspecified illness. The British drug giant voluntarily paused the studies to allow independent committees and international regulators to review the safety data. AstraZeneca said the review by the independent data committee was a standard procedure when there is an unexplained illness observed in a study.
However, it has resumed studies in UK, Brazil, South Africa, India and now in Japan as the regulatory authorities have considered it safe to do so. However, the study in the United States remains on hold and the company is in discussion with the FDA to provide the necessary information to re-start the studies.
Meanwhile, AstraZeneca has not disclosed any medical information about the kind and seriousness of the disease and whether the adverse event was related to the vaccine shot.
So far this year, AstraZeneca’s stock is up 8.8% in contrast to the 1.7% decline of the
Late-stage studies on AZD1222 were ongoing in the United States UK, Brazil, South Africa, India and Japan. The pause in vaccinations covered the studies in the United States as well as other countries. The trials aim to enroll up to 50,000 participants globally.
Several drugmakers are working relentlessly to develop a vaccine for the deadly coronavirus disease, which has infected 35.4 million people globally and killed more than 1 million.
AstraZeneca’s COVID-19 vaccine candidate was probably the most advanced in terms of development and was being viewed as one of the first candidates to reach the market. However, the voluntary suspension might have delayed the timeline of the studies and subsequently the vaccine’s approval. Other than AstraZeneca/Oxford University, COVID-19 vaccine candidates of Moderna
), J&J ( MRNA JNJ Quick Quote JNJ - Free Report) and Pfizer ( PFE Quick Quote PFE - Free Report) /BioNTech are also in late-stage development. J&J began a pivotal phase III study last month. While J&J is testing a single dose of its investigational COVID-19 vaccine candidate, JNJ-78436735, Pfizer/BioNTech, AstraZeneca/Oxford University and Moderna are testing two shots of their respective candidates.
Meanwhile the FDA granted Breakthrough Therapy Designation (BTD to AstraZeneca’s blockbuster medicine, Farxiga in patients with chronic kidney disease (CKD) with and without type-II diabetes. The designation was based on data from the phase III DAPA-CKD study, which showed that Farxiga significantly reduced the composite measure of worsening of renal function or risk of death in the study by 39% in patients with CKD Stages 2-4 and elevated urinary albumin excretion in patients with and without type-II diabetes.
Farxiga, a diabetes medicine, is also approved to reduce the risk of hospitalization for heart failure (hHF) in patients with type-II diabetes. and established CV disease or multiple CV risk factors.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see
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