Shares of Pfizer Inc.
PFE,
+1.10%

rallied 2.3% and of BioNTech SE
BNTX,
+7.24%

jumped 5.3% in premarket trading Monday, after the companies said two of their vaccine candidates to protect against the virus that causes COVID-19 received Fast Track designation status from the Food and Drug Administration. Fast Track is a process to expedite the review of new drugs and facilitate development of new drugs. Pfizer’s and BioNTech’s BNT162b1 and BNT162b2 are currently being evaluated in Phase 1/2 clinical studies in the U.S. and Germany. “The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.” Pfizer’s stock has dropped 13.7% year to date through Friday while BioNTech shares have more than doubled (up 107.7%) and the Dow Jones Industrial Average
DJIA,
+1.43%

has lost 8.6%.



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