Shares of BioNTech (BNTX 0.82%) were soaring 17.7% as of 10:57 a.m. EDT on Monday. The big gain came after BioNTech and its partner, Pfizer (PFE -0.39%), announced that two vaccine candidates being developed for SARS-CoV-2, the coronavirus that causes COVID-19, received Fast Track designation from the U.S. Food and Drug Administration (FDA).
It makes sense that the biotech stock jumped today; receiving Fast Track designation is definitely good news for BioNTech and for Pfizer. The FDA's decision means that the companies' two COVID-19 vaccine candidates, BNT162b1 and BNT162b2, will enjoy an expedited FDA review process. BioNTech and Pfizer will also be able to work more closely with the FDA on clinical trial plans.
Moderna also won Fast Track designation in May for its coronavirus vaccine candidate. But BioNTech and Pfizer are the first to win the designation for two COVID-19 vaccines at the same time. The two companies also have two other experimental coronavirus vaccine candidates in development.
The FDA granted Fast Track designation for BNT162b1 and BNT162b2 after reviewing preliminary data from ongoing phase 1/2 clinical trials. BioNTech and Pfizer announced promising early results from a U.S. study on July 1. Another phase 1/2 study is also underway in Germany.
BioNTech and Pfizer expect to announce preliminary results from the phase 1/2 study being conducted in Germany later this month. The drugmakers also hope to begin a phase 2b/3 clinical trial that will enroll up to 30,000 participants as soon as late July, pending regulatory approval.