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Case Overview

Status:Status:Investigating
Company Name:Company Name:Bright Minds Biosciences
Ticker:Ticker:DRUG
Related Attorneys:Lead Attorneys:Thomas W. Elrod
Related Practices:Related Practices:Securities
On November 2, 2026, Bright Minds announced that the FDA had notified the Company that it had placed the Company’s Phase 2 BMB-101 clinical trial on a partial clinical hold. The clinical trial was designed to evaluate the effectiveness of BMB-101 on Developmental and Epileptic Encephalopathies (“DEE”) using pediatric enrollment. The FDA explained its decision citing toxicity in mice and “inadequate pharmacokinetic and juvenile toxicity data to support the proposed pediatric enrollment.” Bright Minds stated it believes the partial clinical hold “covers only the planned Phased 2 trial of BMB-101 in the United States” and does not affect any other ongoing clinical trials. The Company also stated it believes “the FDA’s observation of toxicity in mice was not seen in any other species… the adverse mouse findings were incidental and not drug-related.” On January 6, 2026, Bright Minds released topline results from its Phase 2 BMB-101 clinical trial, stating that BMB-101 “was safe and well tolerated in patients,” “met both primary and secondary endpoints in Absence Seizures and DEE,” and “demonstrates a potentially best-in-class profile for patients.” On the news of the FDA’s partial clinical hold, the price of Bright Minds shares declined by $28.78 per share, or approximately 52.3%, from $54.98 per share on October 30, 2026 to close at $26.20 on November 2, 2026.

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