On Tuesday, the U.S. Meals and Drug Administration (FDA) positioned a scientific maintain on BioNTech SE’s BNTX Investigational New Drug utility (IND) and the associated Section 1/2a trial evaluating the security, tolerability, immunogenicity, and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in wholesome malaria-naive adults.
The multi-antigen malaria vaccine (designated BNT165e) is a mix of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2).
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The trial was anticipated to enroll round 177 members and conclude in September 2025. BioNTech has proactively paused the research, the SEC filing famous, and is taking actions to deal with the FDA’s requests and can work with the FDA to evaluate the subsequent steps.
In October, the FDA imposed a partial scientific maintain on BioNTech’s companion, OncoC4 Inc.’s Section 3 PRESERVE-003 trial. Various outcomes between sufferers with squamous and non-squamous non-small cell lung most cancers triggered the partial maintain.
Additionally in August, the FDA lifted the partial scientific maintain on MediLink Therapeutics’ Section 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate.
The choice, introduced on August 15, follows the submission of an entire response that features information evaluation, up to date documentation, and extra danger mitigation measures.
Value Motion: BNTX inventory is up 3.11% at $113.06 on the final test Wednesday.
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