Shionogi Submits NDA for COVID-19 Antiviral Ensitrelvir to FDA

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Shionogi Submits NDA for COVID-19 Antiviral Ensitrelvir to FDA

Shionogi & Co ( (JP:4507) ) has issued an update.

Shionogi & Co., Ltd. has initiated a rolling submission of a new drug application with the U.S. FDA for its oral antiviral ensitrelvir, intended for post-exposure prophylaxis of COVID-19. This submission follows positive results from the SCORPIO-PEP Phase 3 study, which demonstrated the drug’s efficacy in preventing symptomatic COVID-19. If approved, ensitrelvir would be the first orally-administered option for post-exposure prophylaxis of COVID-19, potentially enhancing Shionogi’s market position and offering a new preventive measure amid decreasing vaccination rates and emerging variants.

More about Shionogi & Co

Shionogi & Co., Ltd. is a pharmaceutical company based in Osaka, Japan, primarily focused on developing and marketing drugs for infectious diseases. The company is known for its research and development in antiviral medications, particularly in response to the COVID-19 pandemic.

YTD Price Performance: 11.42%

Average Trading Volume: 1,335

Technical Sentiment Signal: Sell

Current Market Cap: $13.6B

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