Biotech bigwig Gilead Sciences, Inc. GILD announced that it is currently transitioning to expanded access programs from individual compassionate-use requests for its experimental drug — remdesivir — for the treatment of coronavirus.
We note that Gilead is currently working to evaluate the safety and efficacy of remdesivir as a potential treatment for COVID-19 at the earliest in multiple ongoing studies.
Remdesivir is being used in the United States for the treatment of the disease under federal rules that allow the use of unapproved drugs on compassionate grounds. The candidate was previously under testing for Ebola virus.
The company has provided emergency access to remdesivir for several hundred patients in the United States, Europe and Japan.
However, given the exponential rise in compassionate-use requests for emergency access to remdesivir, Gilead has decided to offer the drug under an expanded-access program to accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with the national regulatory authorities worldwide.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if these are effective in treating the infected patients.
As the candidate has shown promising results in infected patients, investors are banking on Gilead for being the first company to come up with a treatment for this deadly disease. Initial data from the ongoing studies are expected in the upcoming weeks.
Last week, Gilead asked the FDA to rescind the Orphan Drug designation granted to its experimental drug, remdesivir, for the treatment of coronavirus. However, Gilead has asked the agency to revoke the same after facing criticism to seek benefits amid global health crisis. The biotech firm was earlier accused of exorbitantly pricing its HCV drugs.
While Gilead is pioneering the race for developing a potential cure for COVID-19, other companies have joined the bandwagon as well.
Regeneron Pharmaceuticals REGN too has identified antibodies, which can possibly treat coronavirus. Regeneron and partner Sanofi SNY are also evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19.
President Trump reportedly wants to speed up the approvals of vaccines and treatments to fight the pandemic.
Johnson & Johnson JNJ recently announced the selection of a lead coronavirus vaccine candidate.
Desperate times call for desperate measures and pharma/biotech companies are running a race against time to successfully develop treatments and vaccines to combat this contagious disease. While the drugs and vaccines will need some time to be tested and a cure is not imminent, investors will keep an eye on the above-discussed companies as the pandemic is unlikely to die out any time soon.
Gilead currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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