What happened
Shares of German clinical-stage biotech BioNTech (BNTX 0.25%) soared 45.5% in November, according to data from S&P Global Market Intelligence.
For context, the S&P 500 returned 11% last month.
Image source: Getty Images.
So what
BioNTech's strong performance last month was due to a spate of great news about the company's vaccine candidate, BNT162b2, for the novel coronavirus, which causes the disease COVID-19. It developed the messenger RNA (mRNA) vaccine with its partner, pharmaceutical giant Pfizer (PFE +0.30%).
Shares of BioNTech rocketed 22.6% in the two-day period following the partners' Nov. 9 announcement that their vaccine candidate was more than 90% effective in preventing COVID-19 based on initial data from a large-scale phase 3 clinical study. In addition, they said they had found no serious safety concerns.
Shares jumped 9.2% in the two-day period following the two companies' Nov. 18 announcement outlining the very positive final results from the phase 3 study. BNT162b2 was found to be 95% effective against COVID-19 beginning 28 days after the first of the two-dose vaccination. Moreover, the partners achieved the safety data milestone required by the Food and Drug Administration for the vaccine to be considered for an Emergency Use Authorization (EUA).
Then on Nov. 20, shares of BioNTech moved up 9.6% following the two companies' announcement that on that day they planned to submit an EUA request to the FDA. That move made them the first to reach this milestone. Moreover, the partners said they "have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K."
Now what
BioNTech and Pfizer started December with a bang, as on Wednesday the U.K. became the first country to give the regulatory green light to BNT162b2.
Investors in BioNTech and Pfizer can probably expect the FDA's official decision by the middle of this month. The agency has scheduled a meeting on Dec. 10 to discuss the companies' request for an EUA. The FDA's granting of an EUA for BNT162b2 seems as close to a sure thing as it gets.
BioNTech and Pfizer expect to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.
