Shares of Gilead Sciences, Inc. GILD were up 2.1% after it announced additional data on experimental drug, remdesivir.
A comparative analysis of the phase III SIMPLE-Severe study and a real-world retrospective cohort of patients with severe COVID-19 showed that remdesivir was associated with an improvement in clinical recovery and a 62% reduction in the risk of mortality compared with standard of care.
This comparative pre-planned analysis included 312 patients treated in the phase III SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity, who received standard-of-care treatment in the same time period as the SIMPLE-Severe study.
The mortality rate for patients treated with remdesivir in the analysis was 7.6% at day 14 compared with 12.5% among patients not taking the drug.
However, this analysis will require confirmation in prospective clinical trials, per the company.
While the data was overall encouraging, the company’s comparison of two different populations was confusing.
Meanwhile, separate subgroup analyses from the phase III SIMPLE-Severe study, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study.
Additionally, new analyses of the company’s compassionate use program demonstrated that 83% of pediatric patients (n=77) and 92% of pregnant and postpartum women (n=86) with a broad spectrum of disease severity recovered by day 28.
We note that Gilead recently initiated a global, open-label phase II/III study to evaluate the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. The company is also collaborating on a study for pregnant women.
Gilead’s shares have rallied 20.4% in the year so far compared with the industry’s growth of 7.4%. In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.
The FDA also granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic. It was granted regulatory approval in Japan under an exceptional approval pathway. The European Commission has granted conditional marketing authorization to remdesivir as a treatment for SARS-CoV-2 infection, under the brand name Veklury.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion.
Roche RHHBY initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia. Alexion ALXN is also evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
Regeneron REGN has also initiated late-stage studies on its investigational double-antibody cocktail, REGN-COV2, for the treatment of COVID-19. The candidate is being evaluated both for the treatment and prevention of the disease.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Best Stocks from Zacks
Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2019, while the S&P 500 gained and impressive +53.6%, five of our strategies returned +65.8%, +97.1%, +118.0%, +175.7% and even +186.7%.
This outperformance has not just been a recent phenomenon. From 2000 – 2019, while the S&P averaged +6.0% per year, our top strategies averaged up to +54.7% per year.
See their latest picks free >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Alexion Pharmaceuticals, Inc. (ALXN) : Free Stock Analysis Report
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research