Bright Minds shares fall 52% after FDA partial clinical hold on seizure drug

Bright Minds Biosciences said the FDA placed its application and planned trial for BMB-101, a seizure drug for developmental and epileptic encephalopathies, on partial clinical hold following a review. The FDA cited toxicity in mice and inadequate pharmacokinetic and juvenile toxicity data to support proposed pediatric enrollment. Bright Minds said it believes the mouse toxicity finding was not seen in other species and was not related to its drug, citing toxicity reports, peer reviewers and independent toxicology expert opinions. The stock dropped 52% to C$36.98.