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Gilead Asks FDA to Withdraw Orphan Drug Tag for Remdesivir

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Zacks Equity Research
·4-min read
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Shares of Gilead Sciences, Inc. GILD were down 5.8% after it reportedly asked the FDA to rescind the Orphan Drug designation granted to its experimental drug, remdesivir, for the treatment of COVID-19.

On Mar 23, 2020, the agency had granted remdesivir the Orphan Drug designation for the treatment of COVID-19.

Gilead had initiated two phase III studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19. These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries.

The studies will assess two dosing durations of the candidate, administered intravenously. Reportedly, remdesivir is already 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 the Ebola virus. As the candidate has shown promising results in the infected patients, investors are banking on Gilead for being the first company to come up with a treatment for this deadly disease.

We note that the Orphan Drug designation is generally granted to drugs being developed for rare diseases, which affect less than 200,000 persons in the United States. The designation gives special tax and market exclusivity incentives.

However, Gilead has asked the agency to revoke the same after facing criticism to seek benefits amid a global health crisis.

The biotech was earlier accused of exorbitant pricing of its HCV drugs.

We note that there are currently 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 they are effective in treating infected patients.

Gilead’s shares have gained 7.2% this year so far against the industry’s decline of 13.4%.


Regeneron Pharmaceuticals REGN too has identified antibodies, which can possibly treat COVID-19. The company has now isolated hundreds of virus-neutralizing, fully-human antibodies from its VelocImmune mice, which have been genetically modified to have a human immune system.

The company has also isolated antibodies from humans who have recovered from COVID-19 to maximize the pool of potent antibodies. The company plans to select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein as well as other desirable qualities. Earlier,

Regeneron and partner Sanofi SNY announced a program to evaluate 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.

Earlier this week, Roche RHHBY obtained FDA nod to conduct a double-blind, placebo-controlled phase III study to evaluate the safety and efficacy of intravenous rheumatoid arthritis (RA) drug, Actemra (tocilizumab), plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

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 these companies as the pandemic is not likely to die out 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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