Bright Minds Biosciences Investigation Notice: Levi & Korsinsky Notifies Investors of Pending Investigation Into Bright Minds Biosciences (DRUG)

The FDA cited mouse toxicity findings and insufficient pharmacokinetic and juvenile-toxicity data when it placed Bright Minds' planned Phase 2 BMB-101 epilepsy trial on partial clinical hold. An investigation is underway on behalf of DRUG investors who suffered losses.

NEW YORK, Nov. 2, 2026 /PRNewswire/ -- Mouse toxicity findings and insufficient juvenile-toxicity data led the FDA to place Bright Minds Biosciences' (NASDAQ: DRUG) planned Phase 2 BMB-101 epilepsy trial on partial clinical hold, and DRUG shares sold off sharply. If you bought Bright Minds stock and lost money after the hold was announced, you may have legal rights. Investors who suffered losses are encouraged to request a free review of their losses or contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

The FDA cited three concerns: toxicity findings in mice, insufficient pharmacokinetic data, and insufficient juvenile-toxicity data to support enrolling pediatric patients. The planned U.S. study was designed to evaluate BMB-101 in epilepsy and developmental and epileptic encephalopathies (DEE), with pediatric enrollment.

Bright Minds stated the hold was limited to the planned U.S. study and emphasized that its other ongoing trials were unaffected, but the FDA's action raised broader questions about the safety data supporting BMB-101 and the Company's ability to advance the program as planned. Moreover, despite publicly disagreeing with the FDA's interpretation of the mouse toxicity findings, Bright Minds acknowledged that it had not yet received the agency's full letter and that additional data or studies could be required. As a result, the Company faced potentially significant delays and additional development requirements, leaving the planned study's design, timing, and regulatory pathway uncertain.

The Levi & Korsinsky investigation into potential securities law violations is ongoing. Shareholders who lost money on DRUG can check whether they qualify to recover losses or call (212) 363-7500.

WHY LEVI & KORSINSKY -- Ranked in ISS Securities Class Action Services' Top 50 Report for seven consecutive years, Levi & Korsinsky, LLP is a nationally recognized leader in shareholder rights litigation. With a team of over 70 professionals, the firm has recovered hundreds of millions of dollars for investors.

Frequently Asked Questions About the DRUG Investigation

Q: What is the DRUG investigation about?A: An investigation is pending concerning Bright Minds Biosciences (NASDAQ: DRUG) regarding potential securities law violations. Shares sold off sharply after the Company disclosed that the FDA had placed its planned Phase 2 BMB-101 trial on partial clinical hold. The FDA cited toxicity findings in mice and insufficient pharmacokinetic and juvenile-toxicity data. The selloff caused losses for shareholders.

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 is examining whether Bright Minds made materially misleading statements or omissions regarding BMB-101's clinical development and the planned Phase 2 program, particularly whether the Company adequately disclosed known regulatory risks associated with preclinical toxicity findings and insufficient pharmacokinetic and juvenile-toxicity data. When the Company disclosed the FDA's 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. Bright Minds shares trade on the NASDAQ under the ticker DRUG.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
[email protected]
Tel: (212) 363-7500
Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP