Pharma Stock Roundup: LLY, AZN, PFE, GSK Progress on Coronavirus Programs

This week, Eli Lilly LLY filed for emergency use of its coronavirus antibody candidate, and Pfizer PFE / BioNTech has started filing for COVID-19 vaccine approval in Europe. AstraZeneca AZN resumed its COVID-19 vaccine study in Japan.
Review of the week's most important stories
Lilly Submits EUA for Antibody Candidates, LYCoV555: Lilly filed with the FDA for Emergency Use (EUA) approval for its antibody therapy candidate LYCoV555 as a monotherapy for the treatment of higher risk patients recently diagnosed with a mild diagnosis-moderate COVID-19. The company also released promising data from the combination cohort of the Phase II BLAZE-1 study, showing that an antibody combination, LYCoV555 and LY-CoV016, reduced symptoms of viral load and COVID-19-related hospital stays and emergency rooms.
The application for EUA was based on these dual therapy data as well as data from the monotherapy cohort published last month. Lilly will file a separate application for EUA for combination therapy in November.
Meanwhile, Lilly has entered into an agreement with the Bill & Melinda Gates Foundation to supply their potential COVID-19 antibody therapy to low and middle income countries. The deal is part of the foundation's philanthropic program COVID-19 Therapeutics Accelerator (CTA), which aims to bring effective COVID-19 drugs to market quickly. Commercial production of the candidate will begin in April 2021 at CTA's reserved production facility in Denmark.
EMA Starts On-going Review of Pfizer's Coronavirus Vaccine: Pfizer / BioNTech began ongoing filing of its mRNA-based coronavirus vaccine candidate BNT162b2 with the European Medicines Agency (EMA). The EMA accepted an ongoing review of the candidate based on the available preclinical and clinical data.
As part of the ongoing review process, the EMA Committee for Medicinal Products for Human Use has started to evaluate the preclinical data. After completing the ongoing review process, the final / formal marketing proposal will be submitted once the EMA is satisfied that the data submitted is appropriate and demonstrates the effectiveness and safety of the vaccine.
In the meantime, Pfizer and partner OPKO Health announced favorable top-line data from a Phase III study of Somatrogon given once a week to growth hormone deficient children aged 3 to <18 years. The study met its primary endpoint by showing an improved treatment load of somatrogon injection compared to once daily somatropin injection (current standard of treatment) as measured by the mean total score for life interference. The effectiveness of Somatrogon observed in the study demonstrates its potential for reducing lifestyle disruptions, supporting patient preference, and improving adherence compared to somatropin.
In the meantime, Pfizer and partner Sangamo announced the initiation of a Phase III study to evaluate the giroctocogene fitelparvovec / SB-525, an experimental gene therapy in patients with severe hemophilia A.
AstraZeneca Restarts COVID-19 Vaccine Trial in Japan: AstraZeneca resumed Phase I / II clinical trials of its COVID-19 vaccine candidate AZD1222 in Japan after restarting trials in the UK, Brazil, South Africa and India. Last month, AstraZeneca temporarily suspended all worldwide late-stage studies on AZD1222, which are being developed in partnership with Oxford University, because a patient in the UK had an unspecified disease. While the international trials have now resumed, the US trial is on hold and the company is in discussion with the FDA to provide the information needed to restart the trials.
Glaxo / Vir Biotech's COVID-19 antibody drug enters phase III: Glaxo GSK and its partner Vir Biotech announced the global expansion of the COMET-ICE study of their monoclonal antibody VIR-7831 for the early treatment of COVID- 19 in phase III to patients at high hospital risk. The study continued on the recommendation of an independent data monitoring committee based on positive data from the leader in part of the Phase II COMET ICE study in Phase III. First data from the Phase III study are expected by the end of 2020, while results for the primary endpoint are expected in the first quarter of 2021.
The COMET program also includes two other studies, one to treat hospital patients and one to prevent symptomatic infections. The study is part of a collaboration agreement between Glaxo and Vir Biotechnology signed in April to develop antibody treatments for coronaviruses including SARS-CoV-2.
J&J Agrees to Ship 200 Million Doses of Coronavirus Vaccine to European Countries: J & J JNJ announced an agreement with the European Commission to ship 200 million doses of its COVID-19 investigational candidate to European countries after approval. The agreement also provides an option for EU member states to secure up to 200 million additional doses.
J&J started a large pivotal Phase III trial this month to evaluate the safety and efficacy of a single dose of its COVID-19 vaccine candidate JNJ-78436735. J&J has signed a similar pre-delivery agreement to provide 100 million doses of its candidate to the US government. J&J is committed to delivering more than a billion doses worldwide by the time the vaccine is approved.
EMA accepts Sanofi's Pompe disease application: The European Medicines Agency has accepted Sanofi's SNY application for approval to review its investigational enzyme replacement therapy avalglucosidase alfa for the treatment of late-onset Pompe disease. The marketing authorization application is based on data from two studies involving both patients with Pompe disease and patients with late onset. The EMA is expected to make its decision in the second half of 2021.
Novo Nordisk raises outlook for 2020: Novo Nordisk NVO has raised its previously published outlook for 2020 sales and operating profit growth due to less negative than expected impact of COVID-19. Revenue growth at constant exchange rates (CER) is expected to be in the range of 5 to 8% versus previous expectations in the range of 3 to 6%. The growth expectations for the operating result were raised from 2-5% to 5-8%. The company also announced preliminary third quarter revenue and operating profit growth rate. Novo Nordisk sales at CER increased 7% and operating income increased 7% in the third quarter.
The NYSE ARCA Pharmaceutical Index rose 1.13% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR% return
Large Cap Pharmaceuticals Industry 5YR% return
Large Cap Pharmaceuticals Industry 5YR% return
This is how the eight main stocks have performed in the last five trading sessions.
In the last five trading sessions, Lilly saw the maximum increase (6.3%) while Merck fell the most (1.5%).
In the past six months, AstraZeneca has risen the most (21.1%) while Merck has decreased the most (2.5%).
(See the final pharmaceutical inventory summary here: FDA Approves New Uses of PFE, JNJ, and GSK Drugs)
What's next in the pharmaceutical world?
Keep an eye out for J & J's third quarter results, as well as regular pipeline and regulatory updates next week.
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