Gilead Sciences Inc. (GILD) said it expects to produce more than 2 million treatment courses of its experimental coronavirus drug candidate remdesivir by the end of the year and many millions more in 2021.
After getting the green light from the U.S. Food and Drug Administration (FDA), Gilead announced that it is planning to start Phase 1 trials of an inhaled version of remdesivir this week and begin studies in patients with COVID-19 in August.
Remdesivir is an investigational antiviral virus candidate, which is currently given to patients intravenously through daily infusions in the hospital. An inhaled formulation would be given through a nebulizer, which Gilead said could potentially allow for easier use outside the hospital, at earlier stages of the disease.
“That could have significant implications in helping to stem the tide of the pandemic,” Gilead CEO Daniel O’Day said in an open letter.
O’Day added that the company is also exploring whether patient outcomes can be improved by combining remdesivir with other therapies to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response.
In addition, Gilead announced plans for a “next wave of studies” of remdesivir, which will include vulnerable patient populations, including a study in pregnant women.
Remdesivir is a viral RNA polymerase inhibitor which means that it interferes with the production of viral genetic material, preventing the virus from multiplying. Gilead’s investigational antiviral therapy has received Emergency Use Authorization (EUA) by the FDA to treat COVID-19.
Shares in Gilead declined 1.6% to $76.23 in midday U.S. trading trimming the year-to-date advance to about 17%.
For now though, Wall Street analysts remain sidelined on the stock. The Hold consensus is based on 14 Hold ratings and 4 Sell ratings versus 10 Buy ratings. The $79.95 average price target implies a modest 4.7% upside potential in the shares in the coming 12 months. (See Gilead stock analysis on TipRanks).
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