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BioNTech SE Faces FDA Trial Hold Over Safety
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BioNTech SE Faces FDA Trial Hold Over Safety

BioNTech SE (BNTX) has released an update.

BioNTech SE has announced that the FDA has implemented a partial clinical hold on a Phase 1 trial for a BioNTech-partnered cancer drug, citing potential risks at higher doses. The trial, aimed at treating advanced cancer patients with a new antibody-drug conjugate, has paused new patient enrollment in the U.S. as the company works to address the FDA’s safety concerns.

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