NEW YORK, Nov. 05, 2026 (GLOBE NEWSWIRE) -- Bright Minds Biosciences (NASDAQ: DRUG) shareholders are holding losses after the stock sold off sharply on news of an FDA partial clinical hold on the Company's planned Phase 2 BMB-101 trial in epilepsy and developmental and epileptic encephalopathies (DEE). If you bought DRUG shares and watched their value fall on the clinical hold news, you may have legal rights. Investors who suffered losses are encouraged to submit your loss information now. You may also contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500.
According to multiple published reports, the FDA based the hold on toxicity findings in mice. The agency also said the pharmacokinetic and juvenile-toxicity data were not sufficient to support pediatric enrollment in the planned U.S. study. Bright Minds stated that it disagreed with the FDA's interpretation of the mouse findings. That disagreement did not resolve the agency's concerns.
The Company said it was still awaiting the FDA's full letter. The Company stated that it was awaiting the FDA's full clinical hold letter and acknowledged that additional data or studies might be required to address the agency's concerns before the planned U.S. study could proceed. Levi & Korsinsky is investigating whether Bright Minds may not have adequately disclosed risks tied to BMB-101's preclinical safety data before the hold was announced.
If you purchased Bright Minds shares and lost money after the clinical hold, request a free review of your DRUG losses or call (212) 363-7500.
ABOUT LEVI & KORSINSKY, LLP -- Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders. The firm has extensive expertise in complex securities litigation and a team of over 70 employees. For seven consecutive years, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report.
Frequently Asked Questions About the DRUG Investigation
Q: Who is conducting the DRUG investigation? A: Levi & Korsinsky, LLP is investigating potential securities law claims on behalf of investors who purchased DRUG securities. The firm is nationally recognized, ranked in the ISS Top 50 for seven consecutive years, and has recovered hundreds of millions of dollars for aggrieved investors.
Q: Who is eligible to participate in the DRUG investigation? A: Investors who purchased DRUG stock or securities and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses -- not on whether you still hold the shares.
Q: Which statements are being investigated as potentially misleading? A: The investigation concerns whether Bright Minds Biosciences made materially false or misleading statements regarding the BMB-101 program, including its preclinical safety data and readiness for pediatric enrollment. When the Company disclosed that the FDA had placed its planned Phase 2 BMB-101 trial on partial clinical hold, the stock price declined sharply.
Q: What do DRUG investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible to participate in the investigation.
Q: What documents do I need to participate? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.
Q: What if I already sold my DRUG shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought DRUG and sold at a loss may still participate in the investigation.
Q: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in any resulting action, these matters are generally handled on a contingency basis, with any attorneys' fees and expenses subject to court approval.
Q: What if I live outside the United States? A: U.S. securities investigations generally cover purchases on U.S. exchanges regardless of the investor's country of residence.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
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