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Gilead (GILD) Gains 13% YTD on Coronavirus Drug Development


Shares of Gilead Sciences, Inc. GILD have been up 13.1% in the year so far compared with the industry’s growth of 7.3%.

The stock has been in the news from the onset of the year due to its promising experimental coronavirus drug, remdesivir.

Gilead initiated two open-label phase III studies in February (SIMPLE studies) on experimental candidate, remdesivir, for COVID-19. Additional global studies are ongoing, including a global, placebo-controlled trial being led by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) as well as the more recently-initiated studies through the World Health Organization and INSERM in France.

NIAID recently announced that the preliminary results from the trial met the primary endpoint and remdesivir was found to shorten the time of recovery for hospitalized patients with COVID-19, when compared with a placebo. Gilead also announced top-line results from the first SIMPLE study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe COVID-19 disease. The study demonstrated similar clinical improvements in patients with severe symptoms of COVID-19, regardless of whether they received five or ten days of treatment.

It was recently granted regulatory approval in Japan under the brand name, Veklury as a treatment for SARS-CoV-2 infection. The approval came under an exceptional approval pathway.

As the candidate has shown promising results in infected patients, Gilead is being touted as the first company in the United States to come up with a treatment for this deadly disease. A possible outcome will significantly boost prospects until vaccines are available.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, quite a few biotechs are evaluating their approved drugs or pipeline candidates to determine if they are effective in treating the infected patients.

Meanwhile, Gilead’s HIV franchise maintains momentum, driven by the strong performance of Biktarvy. Encouraging initial uptake of Descovy for the PrEP setting also boosted the business.

However, the HIV business faces stiff competition from ViiV Healthcare, a joint venture of Glaxo GSK and Pfizer PFE.

Gilead is looking to diversify its business as well. The company and partner Galapagos NV GLPG recently announced positive top-line results from a late-stage study on its investigational, oral, once-daily, selective JAK1 inhibitor filgotinib. The results showed that a higher dose of the candidate achieved the desired results. A potential approval will bode well for Gilead.

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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