Gilead Down on Mixed Results From Coronavirus Drug Remdesivir

Shares of Gilead Sciences, Inc. GILD were down 3.43% after it reported mixed results from a late-stage study on investigational antiviral remdesivir in hospitalized patients with moderate COVID-19 pneumonia.

The open-label phase III SIMPLE study evaluated five-day and 10-day courses of remdesivir plus standard of care as compared to only standard of care in these patients.

Hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for five or 10 days or standard of care alone. The primary endpoint was the clinical status as assessed by a seven-point ordinal score at day 11, ranging from hospital discharge to increasing levels of oxygen and ventilator support to death. The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.

Data showed that patients in the five-day remdesivir treatment group were 65% more likely to have clinical improvement at day 11 compared with those in the standard of care group.

However, the odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care alone were favorable but did not attain statistical significance.

Consequently, shares were down on the data.

Remdesivir was generally well-tolerated in both five-day and 10-day treatment groups and no new safety signals were identified in either of them.

Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

We remind investors that the FDA granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, given the severity of the pandemic.

Remdesivir is currently approved in Japan as a treatment for patients infected with COVID-19.

Management emphasized that early intervention in the disease process with a five-day treatment course can significantly improve clinical outcomes for these patients.

Meanwhile, The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and early treatment improved clinical outcomes.

Gilead’s shares have rallied 15.7% in the year so far compared with the industry’s growth of 9.1%. The stock has been in the news from the onset of the year due to remdesivir.

Roche RHHBY too initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia.

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. Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.

Earlier, Incyte INCY initiated RUXCOVID, a global, randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of Jakafi plus SoC in patients 12 years and above with COVID-19-associated cytokine storm. Alexion ALXN is evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.

Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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