BioNTech resumes Phase I trial after FDA lifts partial hold

19 August 2024

BioNTech (Nasdaq: BNTX) and MediLink Therapeutics have resumed recruitment for their Phase I trial of BNT326/YL202, following the US Food and Drug Administration's decision to lift a partial clinical hold.

The FDA initially imposed the hold in June 2024 due to safety concerns but lifted it after trial protocols and additional risk mitigation measures were implemented.

The ongoing trial focuses on BNT326/YL202, an antibody-drug conjugate (ADC) targeting Human Epidermal Growth Factor Receptor 3 (HER3).

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