Gilead Submits New-Drug Application for Remdesivir

Gilead Sciences submitted a new-drug application to the U.S. Food and Drug Administration for remdesivir, its coronavirus treatment.
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Gilead Sciences  (GILD) - Get Report shares fell Monday after the company submitted a new-drug application to the U.S. Food and Drug Administration for remdesivir, its treatment for patients infected with the coronavirus.

Gilead’s progress on remdesivir hasn’t done much for the stock in recent weeks, because it will initially give massive amounts away for free and hasn’t set a high price for when it begins charging.

Gilead shares recently traded at $68.26, down 1.6%. The stock has returned 9% year to date through Friday, compared with 5% for the S&P 500.

Gilead, Foster City, Calif., currently offers remdesivir, which it has branded as Veklury, in the U.S. under an emergency-use authorization to treat hospitalized patients with severe Covid-19.

The filing is the final tier of the rolling NDA submission that was initiated on April 8, the company said. 

The filing is supported by data from Phase III studies by Gilead and the National Institute of Allergy and Infectious Diseases, Gilead said. Niaid is directed by the immunologist Anthony Fauci.

“These studies demonstrated that treatment with Veklury led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement," the company said. 

"Across studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified.”

In other covid-related corporate news Monday, German biopharmaceutical company CureVac, a leading entrant in the race to formulate a coronavirus vaccine, said it planned an initial public offering of up to $245 million on the U.S. Nasdaq exchange.