BioNTech reports FDA clinical hold on Phase I/IIa trial of BNT165e

In a regulatory filing, BioNTech (BNTX) disclosed that the U.S. Food and Drug Administration has informed BioNTech SE that it has placed a clinical hold on BioNTech’s Investigational New Drug application and the related Phase I/IIa clinical trial evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine, BNT165e, for prevention of P. falciparum malaria in healthy malaria-naive adults. “BioNTech has complied with the hold by the FDA and, in accordance with the clinical trial protocol, had proactively paused the study. BioNTech is taking actions to address the FDA’s requests and will work with the FDA to assess next steps,” the company stated.