What happened
Shares of Novavax (NVAX) were rising 4.2% higher as of 11:42 a.m. ET on Thursday after climbing as much as 7% earlier in the day. The gain came after the company announced that its partner, Takeda Pharmaceutical (TAK -0.63%), has filed for approval of Novavax's COVID-19 vaccine in Japan.
So what
Regulatory submission in Japan is an important milestone for Novavax. The Japanese government has committed to purchasing 150 million doses of NVX-CoV2373 (known as TAK-019 in Japan) if it wins approval. The financial terms of this supply agreement weren't announced. However, it's safe to say that Novavax could make a significant amount of money if its vaccine wins Japanese approval.
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Novavax and Takeda are working with Japan's Ministry of Health, Labour and Welfare to manufacture NVX-CoV2373/TAK-019 at Takeda's facilities in Japan. The two companies hope to begin distribution early next year if the vaccine is approved.
Novavax also once again confirmed that it remains on track to submit a complete chemistry, manufacturing, and controls data package to the U.S. Food and Drug Administration by the end of 2021. The company has a deal with the U.S. government to supply 100 million doses of NVX-CoV2373 if its wins Emergency Use Authorization.
Now what
Several key catalysts could be on the way that send the vaccine stock even higher. Novavax hopes to soon win authorization for NVX-CoV2373 in Europe. It also awaits regulatory decisions in Australia, Canada, India, New Zealand, Singapore, South Korea, United Arab Emirates, and the United Kingdom, as well as from the World Health Organization.
