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RAPT Therapeutics (NASDAQ:) was downgraded from Buy to Neutral by HC Wainwright on Wednesday following a pause in all clinical trials for its drug zelnecirnon. The action was taken after the US Food and Drug Administration (FDA) suspended clinical trials due to a patient’s death potentially linked to liver failure.
The FDA notification, which RAPT Therapeutics received last Friday, concerns a Phase 2b study for atopic dermatitis (AD) in which liver failure was observed. This incident was identified as potentially related to zelnecirnon, although liver toxicity has not been detected in any of the other approximately 350 patients treated with the drug so far.
The company indicated that it is awaiting further guidance from the FDA on steps needed to resume trials. Additionally, RAPT Therapeutics must evaluate the impact of the suspension on the Phase 2b study and determine whether the study can continue or whether a significant delay in clinical development is unavoidable.
Given the uncertainty surrounding clinical development and potential delays beyond a year if the trial cannot proceed, HC Wainwright removed its price target for RAPT Therapeutics and downgraded the stock to Neutral. The market and investors are now looking for more information from both the FDA and RAPT regarding the future of zelnecirnon clinical trials.
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