FDA pauses RAPT Therapeutics’ immunology drug studies after patient experiences liver failure

The FDA has placed a clin­i­cal hold on two tri­als of RAPT Ther­a­peu­tics’ lead im­munol­o­gy can­di­date, zel­necirnon, the biotech an­nounced Tues­day morn­ing.

A pa­tient in a mid-stage atopic der­mati­tis study ex­pe­ri­enced liv­er fail­ure. While the cause is “cur­rent­ly un­known,” the event was deemed “po­ten­tial­ly re­lat­ed to zel­necirnon,” the com­pa­ny said. The pa­tient has since re­ceived a liv­er trans­plant and has re­cov­ered, ac­cord­ing to RAPT ex­ec­u­tives on a Tues­day morn­ing an­a­lyst call.

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