Bright Minds Biosciences' BMB-101 Phase 2 Trial Placed on FDA Partial Hold

07:58 AM EST, 11/02/2026 (MT Newswires) -- Bright Minds Biosciences (DRUG) said Monday the US Food and Drug Administration placed a partial clinical hold on its investigational new drug application for BMB-101, which is being developed to treat developmental and epileptic encephalopathies. The FDA cited toxicity findings in mice and insufficient pharmacokinetic and juvenile toxicity data to support enrolling pediatric patients in the trial. The hold applies to a planned US phase 2 trial evaluating the drug's safety and effectiveness in treating seizures associated with developmental and epileptic encephalopathies, the company said. Bright Minds said the findings in mice were incidental and unrelated to the drug candidate as similar toxicity was not observed in other animal species. It added that the hold does not affect its other ongoing clinical trials. The company is awaiting the FDA's full clinical hold letter, which the agency expects to provide within 30 days. Additional data or studies may be required and there is no guarantee the hold will be lifted or the US trial will proceed, the company said. Shares of Bright Minds were up more than 4% in recent premarket activity Monday. Price: 57.51, Change: +2.53, Percent Change: +4.60