The law firm of Kirby McInerney LLP reminds investors of its investigation on behalf of Bright Minds Biosciences (“Bright Minds” or the “Company”) (NASDAQ: DRUG) investors concerning the Company’s and/or members of its senior management’s possible violation of the federal securities laws or other unlawful business practices.

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What Happened?

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.

What Should I Do?

At this stage, no lawsuit has been filed. The investigation is ongoing to determine whether claims may be brought under federal securities laws.

If you purchased or otherwise acquired Bright Minds securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.

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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found on Kirby McInerney LLP’s website.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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