Two RAPT Therapeutics Studies Put on Hold by FDA After Adverse Event
By Colin Kellaher
RAPT Therapeutics on Tuesday said the Food and Drug Administration has placed a pair of studies of its zelnecirnon drug candidate on hold following a serious adverse event of liver failure in one patient.
The clinical-stage biopharmaceutical company said the hold covers its Phase 2b study of zelnecirnon in atopic dermatitis and its Phase 2a trial in asthma.
RAPT said the cause of the adverse event, which occurred in the atopic dermatitis study, is unknown but has been characterized as potentially related to zelnecirnon.
RAPT said it has halted dosing of zelnecirnon in both trials and enrollment of new participants.
The company noted that the clinical hold doesn't apply to its study of tivumecirnon in oncology.
Trading in shares of RAPT, which closed Friday at $25.97, was halted premarket on Tuesday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 20, 2024 07:59 ET (12:59 GMT)
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