Shares of Gilead Sciences, Inc. GILD gained 0.82% after it announced the publication of positive final results from the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled, phase III ACTT-1 trial of investigational antiviral Veklury (remdesivir) for the treatment of adults hospitalized with mild-moderate or severe COVID-19.
The Adaptive COVID-19 Treatment Trial (ACTT-1) is an international, randomized phase III study that evaluated a 10-day course of Veklury plus standard of care in more than 1,000 hospitalized adult patients with mild/moderate to severe symptoms of COVID-19, including those who were critically ill and required mechanical ventilation at screening.
These results demonstrated that treatment with Veklury resulted in a faster time to recovery than previously reported. Veklury in combination with standard of care shortened the time to recovery by four days compared with placebo plus standard of care (11 days versus 15 days) in the preliminary day 15 results. Results from the final 29 days showed that Veklury achieved clinical recovery five days faster than those receiving placebo, with a median time to recovery of 10 days with Veklury versus 15 days with placebo and an increased recovery rate of 29% compared with placebo.
The study met its primary endpoint, demonstrating that Veklury plus standard of care was superior in shortening the time to recovery through day 29 compared with placebo plus standard of care.
The results showed that treatment with Veklury resulted in consistent, clinically meaningful improvements across multiple outcome assessments compared with placebo in COVID-19 patients. These data also suggest that giving remdesivir to patients on oxygen may significantly reduce their chances of death as compared to other subgroups.
Meanwhile, multiple ongoing international phase III studies are evaluating the safety and efficacy of Veklury for 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 an Emergency Use Authorization (EUA) to Veklury for the COVID-19 infection.
The company’s shares have lost 1.7% in the year so far against the industry’s growth of 1.9%.
Gilead and Regeneron Pharmaceuticals REGN were in news last week after President Trump tested positive and was being treated with experimental treatments from both companies.
Regeneron recently submitted a request to the FDA for an EUA for its experimental COVID-19 treatment, REGN-COV2. REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically 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.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.
Eli Lilly LLY too recently submitted an initial request to the FDA for granting an EUA to its antibody therapy candidate, LYCoV555, as a monotherapy for the treatment of higher-risk patients, who have recently been diagnosed with mild-to-moderate COVID-19.
Last week, Vir Biotechnology VIR and its partner GlaxoSmithKline announced that they are expanding their COMET-ICE study to phase III. The study is evaluating their monoclonal antibody candidate, VIR-7831, for the early treatment of COVID-19 in patients who are at a high risk of hospitalization.
Gilead 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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