RAPT Therapeutics
said the Food and Drug Administration has placed a hold on two trials of the drug zelnecirnon after a patient taking it suffered liver failure.
Shares of RAPT were down 63% to $9.49 on Tuesday.
The halt has been placed on a Phase 2b trial of zelnecirnon in atopic dermatitis and a Phase 2a trial in asthma, the company said. It was a patient in the dermatitis trial whose liver failed, “the cause of which is currently unknown but which has been characterized as potentially related to zelnecirnon,” RAPT said.
The company said dosing of the drug in both clinical trials and the enrollment of new trial participants has been halted, adding that the hold doesn’t apply to a continuing trial of tivumecirnon in oncology.
“This is an unfortunate and unexpected event, and we are working diligently to get more information on this case,” said Chief Executive Officer Brian Wong. “Patient safety is our top priority and we will work with the FDA to resolve this as quickly as possible.”
Cantor Fitzgerald analyst Prakhar Agrawal downgraded shares to Neutral from Overweight in a report Tuesday, writing that “given several unknowns — we believe it’s better to wait to get clarity on these issues.”
Write to Emily Dattilo at [email protected]
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