Gilead Sciences Gains Remdesivir Approval in Japan

Health and Healthcare

Published: May 8, 2020 11:32 am

Gilead Sciences Inc. (NASDAQ: GILD) took another big step forward in its treatment for COVID-19 on Friday when a Japanese regulatory body approved that treatment.

Specifically, the Japanese Ministry of Health, Labour and Welfare has granted regulatory approval of Veklury (remdesivir) as a treatment for infection by SARS-CoV-2, the virus that causes COVID-19, under an exceptional approval pathway.

This exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization (EUA) of remdesivir in the United States. Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) issued the EUA for remdesivir for the treatment of COVID-19.

Also, the Japanese approval was based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 Simple trial in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program, including patients in Japan.

Merdad Parsey, MD, Ph.D., chief medical officer of Gilead Sciences, commented:

The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic. We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.

Gilead stock traded at $77.51 on Frida, in a 52-week range of $60.89 to $85.97. The consensus price target is $80.39.

24/7 Wall St.
20 Bold Companies Raising Dividends Right Into the Recession

It’s Your Money, Your Future—Own It (sponsor)

Are you ahead, or behind on retirement? For families with more than $500,000 saved for retirement, finding a financial advisor who puts your interest first can be the difference, and today it’s easier than ever. SmartAsset’s free tool matches you with up to three fiduciary financial advisors who serve your area in minutes. Each advisor has been carefully vetted and must act in your best interests. Start your search now.

If you’ve saved and built a substantial nest egg for you and your family, don’t delay; get started right here and help your retirement dreams become a retirement reality.