BioNTech SE (NASDAQ: BNTX) shares shot up on Wednesday after the company announced, in conjunction with Pfizer Inc. (NYSE: PFE), that its COVID-19 vaccine program was approved in Germany.
Specifically, the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection.
BioNTech and Pfizer are jointly developing BNT162. The trial is the first clinical trial of a COVID-19 vaccine candidate to start in Germany and is part of a global development program. Pfizer and BioNTech also will conduct trials for BNT162 in the United States upon regulatory approval, which is expected shortly.
Separately, BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.
Ugur Sahin, CEO and co-founder of BioNTech, commented:
We are pleased to have completed pre-clinical studies in Germany and will soon initiate this first-in-human trial ahead of our expectations. The speed with which we were able to move from the start of the program to trial initiation speaks to the high level of engagement from everyone involved.
Albert Bourla, Pfizer board chair and chief executive, commented:
Pfizer and BioNTech’s partnership has mobilized our collective resources with extraordinary speed in the face of this worldwide challenge. Now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this unique and robust clinical study program in the United States in the near future.
BioNTech stock traded up about 14% on Wednesday, at $48.18 in a 52-week range of $12.52 to $105.00. The consensus price target is $38.44.
Pfizer stock was up about 2% to $36.46. The 52-week range is $27.88 to $44.56, and the consensus price target is $41.14.
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