Bright Minds Biosciences plunges after FDA puts epilepsy drug trial on partial hold
DRUG•Bright Minds Biosciences shares fell 49% premarket after the FDA placed a partial clinical hold on its mid-stage BMB-101 trial in developmental and epileptic encephalopathies. The agency cited toxicity in mice and insufficient pharmacokinetic and juvenile toxicity data for planned pediatric enrollment.
1. FDA places partial hold
The FDA placed a partial clinical hold on Bright Minds Biosciences’ mid-stage trial of BMB-101 in developmental and epileptic encephalopathies, citing toxicity seen in mice and insufficient pharmacokinetic and juvenile toxicity data to support planned pediatric enrollment. The company said the hold affects only the planned U.S. study and does not affect its other ongoing clinical trials; it plans to seek clarification from the FDA and update the study based on the agency’s recommendations.
