The FDA placed a partial clinical hold on Bright Minds Biosciences’ planned U.S. Phase 2 study of BMB-101 for seizures associated with developmental and epileptic encephalopathies (DEE).
The FDA cited toxicity findings in mice and said pharmacokinetic and juvenile-toxicity data were not sufficient to support enrolling children.
Bright Minds says the hold applies to this planned U.S. DEE study, not its other ongoing clinical trials. The company says the mouse finding was not seen in other species and believes it may have been incidental; that is the company’s assessment, not an FDA conclusion.
Shares fell sharply on Nov. 2, 2026—about 52% at the close, according to reports.
The company was awaiting the FDA’s full hold letter, expected within 30 days, and said it would seek clarification and consider changes or additional studies. There is no confirmed timetable for lifting the hold.
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