The stock plunged almost 74% after the announcement of a “serious adverse event” – a case of liver failure – in the trial involving patients with atopic dermatitis, also known as eczema. RAPT said the FDA had “verbally notified” it of the decision and has yet to receive a formal letter from the regulator.
The South San Francisco-based company noted that the cause of the adverse event remains unknown, but “has been characterised as potentially related to zelnecirnon.” The FDA has asked for a full clinical hold, meaning dosing with the drug has to stop and no additional patients can be recruited into studies.
