BMB-101 - (BREAKTHROUGH)

Nov. 2, 2026: Bright Minds Biosciences Inc. (CSE/NASDAQ: DRUG) said the FDA notified the company that its IND and Protocol BMB-101-105 for BMB-101 in developmental and epileptic encephalopathies (DEEs) are under a partial clinical hold. The hold applies to the planned U.S. randomized, placebo-controlled, double-blind Phase 2 trial testing ascending doses of BMB-101 for seizures associated with DEEs.

According to the company, the FDA cited identified toxicity in mice and inadequate pharmacokinetic and juvenile toxicity data to support proposed pediatric enrollment. Bright Minds said the hold appears limited to this U.S. Phase 2 DEE trial and does not affect its other ongoing clinical trials. The company is awaiting the FDA’s full Partial Clinical Hold Letter, which FDA said would be provided within 30 days, and plans to seek clarification and revise the study per FDA recommendations; additional data or studies may be required.

The release also recaps prior BMB-101 data: in Phase 1, 64 healthy volunteers tolerated all tested doses with no serious adverse events. In topline data announced Jan. 6, 2026 from the Phase 2 BREAKTHROUGH trial, 24 adults with drug-resistant absence seizures or DEE had mostly mild (79.6%) or moderate (17.2%) treatment-emergent adverse events, no drug-related serious adverse events, and six DEE patients completing main treatment had a median 63.3% reduction in motor seizures.