H.C. Wainwright lowered the firm’s price target on BioXcel Therapeutics to $60 from $66 and keeps a Buy rating on the shares. The Phase 3 TRANQUILITY II trial met its primary efficacy endpoint but reporting issues raise questions regarding data integrity, the analyst tells investors in a research note. The analyst does not consider this a data integrity problem and notes the serious adverse event did not involve the study drug, the investigator in question was not involved in rating patients’ responses, and the data from the site in question would not have altered the outcome of the TRANQUILITY II study. However, the issue may impact the timeline to approval, says H.C. The firm now expects potential label extension for BXCL501 into the Alzheimer’s disease-associated agitation indication in 2025, while its probability of approval has been downwardly revised to 70% from 80%.
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