Gilead Up on Positive Final Results for Coronavirus Treatment
Gilead Sciences, Inc. GILD shares rose 0.82% after announcing positive final results from the National Institute of Allergy and Infectious Diseases (NIAID) Phase III double-blind, placebo-controlled ACTT-1 study of antiviral studies Veklury (remdesivir) was used to treat adults hospitalized with mild-moderate or severe COVID-19.
The Adaptive COVID-19 Treatment Study (ACTT-1) is an international, randomized phase III study in which a 10-day Veklury course plus standard of care in more than 1,000 adult patients with mild / moderate to severe COVID symptoms in the Hospital was rated. 19, including those who were critically ill and required mechanical ventilation when screened.
These results indicated that treatment with Veklury resulted in a faster time to recovery than previously reported. Veklury combined with the standard of care shortened the time to recovery by four days compared to placebo plus standard of care (11 days versus 15 days) in the preliminary 15th day results. Results from the past 29 days showed that Veklury achieved clinical recovery five days faster than those given placebo, with a median time to recovery of 10 days with Veklury versus 15 days with placebo and an increased recovery rate of 29% when compared to placebo.
The study met its primary endpoint and showed that Veklury plus standard of care significantly reduced time to recovery by day 29 compared to placebo plus standard of care.
The results showed that treatment with Veklury in COVID-19 patients resulted in consistent, clinically meaningful improvements on multiple outcome assessments compared to placebo. These data also suggest that administration of remdesivir to patients with oxygen can significantly reduce the likelihood of death compared to other subgroups.
Several ongoing international Phase III trials are now evaluating the safety and efficacy of Veklury in the treatment of COVID-19 in different patient populations, formulations and in combination with other therapies.
Given the urgent need to treat the infected patients, the FDA granted Veklury an Emergency Use Authorization (EUA) for the COVID-19 infection.
The company's shares are down 1.7% year-to-date versus the industry's 1.9% growth.
Gilead and Regeneron Pharmaceuticals REGN were in the news last week after President Trump tested positive and was treated with experimental treatments from both companies.
Regeneron recently filed an application with the FDA for an EUA for the experimental COVID-19 treatment REGN-COV2. REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and has been specially developed to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. It is being evaluated for both treatment and prevention of COVID-19.
There are currently no FDA-approved treatments for the serious illness caused by SARS-CoV-2. The pharmaceutical / biotech sector is fighting against time to develop treatments and vaccines to cure the contagion. Given the alarming spread and severity of the pandemic, some biotech companies are developing antibodies or evaluating their approved drugs or pipeline candidates to see if they are effective enough to treat the infected patients.
Eli Lilly LLY also recently submitted an initial EUA application to the FDA for its antibody therapy candidate LYCoV555 as monotherapy for the treatment of higher-risk patients recently diagnosed with mild to moderate COVID-19.
Last week, Vir Biotechnology VIR and its partner GlaxoSmithKline announced that they were expanding their COMET-ICE study to Phase III. The study will examine the candidate monoclonal antibody, VIR-7831, for the early treatment of COVID-19 in patients at high hospital risk.
Gilead currently has a Zacks Rank 3 (Hold). The full list of today's Zacks # 1 Rank (Strong Buy) stocks can be found here.
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