What happened

Shares of clinical-stage biotech Moderna (NASDAQ:MRNA) soared 126% in November, according to data from S&P Global Market Intelligence. For context, the S&P 500 returned 11% last month.

In 2020, Moderna stock has rocketed 680% through Friday, Dec. 4, compared to the broader market's 16.5% return over this period.  

Vial with "COVID-19 Vaccine" label surrounded by a syringe and pills.

Image source: Getty Images.

So what

Moderna stock's powerful performance last month was driven by the company's release of a string of great news about its messenger RNA-based vaccine candidate, mRNA-1273, for the novel coronavirus, which causes the disease COVID-19. The largest monthly moves are outlined below.

On Nov. 16, shares jumped 9.6% following the company's announcement that its vaccine candidate was 94.5% effective in preventing COVID-19 based on initial data from a phase 3 clinical study. Moreover, it said that side effects were relatively well tolerated.

In the two-trading-day period ending on Nov. 27, shares soared 28.9% following the company's Nov. 25 announcement that the European Commission had agreed to purchase an initial 80 million doses of its mRNA-1273 vaccine, contingent upon regulatory approval. (The U.S. market was closed on Nov. 26 for Thanksgiving.) Moderna also said that the European Medicines Agency (EMA) had started a rolling review of mRNA-1273 on Nov. 17.

Shares ended the month with a bang, surging 20.2% on Nov. 30 after Moderna announced the positive final results from its phase 3 study. It found its vaccine candidate to be 94.1% effective in preventing COVID-19, and it uncovered no serious safety concerns. Moreover, the company said that it had submitted a request with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for mRNA-1273.

Now what

Investors in Moderna can probably expect the FDA's official decision within about two weeks. The agency has scheduled a meeting on Thursday, Dec. 17, to discuss the company's request for an EUA. That's exactly one week after it meets to discuss the EUA request from BioNTech and partner Pfizer for their COVID-19 vaccine candidate.

Moderna expects to supply up to 20 million vaccine doses in the United States in 2020, and said it remains on track to manufacture 500 million to 1 billion doses globally in 2021.

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