FDA slaps clinical hold on RAPT Therapeutics’ zelnecirnon trials

20 February 2024

US immune-oncology drug developer RAPT Therapeutics’ (Nasdaq: RAPT) market capitalization was decimated after it revealed that the US Food and Drug Administration (FDA) has verbally notified the company that a clinical hold has been placed on the company’s Phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and its Phase IIa trial in asthma.

The development is seen as a significant setback for the company, with its stock slumping 64% at $25.97 in pre-market activity this morning, ahead of a planned investor call.

The company said it expects to receive a formal clinical hold letter from the FDA. The clinical hold determination was based on a serious adverse event of liver failure in one patient in the atopic dermatitis trial, the cause of which is currently unknown but which has been characterized as potentially related to zelnecirnon.

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