Moderna (NASDAQ:MRNA), a clinical-stage vaccine developer, saw its shares jump by as much as 17.8% in pre-market trading Monday morning. The biotech's stock is ripping higher today in response to the overwhelmingly positive late-stage trial results for its COVID-19 vaccine candidate, mRNA-1273.
According to an analysis by an independent, NIH-appointed data safety monitoring board, the vaccine met the pre-specified statistical criteria for efficacy in a large phase 3 trial known as COVE. The vaccine's efficacy came in at a stunning 94.5%. Moderna also noted that the vaccine was generally well tolerated in the trial, with the majority of adverse events being mild to moderate in severity.
Moderna appears well on its way toward grabbing an Emergency Use Authorization from the Food and Drug Administration for mRNA-1273, perhaps before the end of the year. So, if this timeline holds, Moderna's COVID-19 vaccine may be ready for widespread public distribution sometime in January 2021.
Keeping with this theme, the company said it should have approximately 20 million doses ready to ship within the U.S. by the end of 2020. Another 500 million to 1 billion doses of the vaccines are expected to be manufactured for global distribution over the course of 2021.
Is Moderna's stock still a screaming buy following today's double-digit spike? While this clinical win does validate Moderna's messenger RNA vaccine platform in the broad sense, there's a strong case to be made that this news is already baked into the biotech's valuation. Moderna's shares, after all, are now trading at something along the lines of eight times next year's sales forecast. Therefore, investors may want to take a wait-and-see approach with this red-hot biotech stock for the moment.