Gilead Sciences, Inc. (GILD - Free Report) announced that it will start studies for an inhaled version of the experimental coronavirus candidate remdesivir after receiving the green light from the FDA.
The company will screen healthy volunteers for phase I studies this week and expects to commence studies in August.
An inhaled formulation would be given through a nebulizer. Remdesivir is currently given to COVID-19 patients intravenously through daily infusions in the hospital. Per the company, since an inhaled formulation would be given through a nebulizer, it will potentially allow for easier administration outside the hospital, at earlier stages of the infection. This, in turn, could help combat the contagion.
We remind investors that the FDA granted remdesivir an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with severe COVID-19. It has not been approved otherwise.
The company will also conduct trials using intravenous infusions in outpatient settings, such as infusion centers and nursing homes. Gilead is also evaluating remdesivir combined with other therapies to improve patient outcomes.
Gilead is currently conducting randomized, controlled trials of remdesivir to evaluate its safety and efficacy in hospitalized patients. In the NIAID study, remdesivir shortened recovery time by four days, on average. In the SIMPLE study of moderately ill patients (those in hospital but not requiring oxygen), individuals on a five-day course of remdesivir had better clinical outcomes than those receiving standard of care.
The data from the NIAID study also showed that the treatment was most effective in patients who did not require medical ventilation yet, supporting further study in patients with the infection.
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.
Gilead’s shares have rallied 18% in the year so far compared with the industry’s growth of 13.3%. In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.
While a potential approval of remdesivir will be a boost, there is uncertainty regarding the drug’s profitability in the long run.
Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients.
Roche (RHHBY - Free Report) too 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 - Free Report) is evaluating its rare disease drug, Ultomiris (ravulizumab-cwvz), for the COVID-19 infection.
Incyte (INCY - Free Report) 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.
The company 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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