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Monday, November 2, 2026

Bright Minds says FDA places partial clinical hold on IND and planned U.S. Phase 2

 

Bright Minds says FDA places partial clinical hold on IND and planned U.S. Phase 2 trial of BMB-101 for developmental and epileptic encephalopathies

  • FDA cited mouse toxicity findings and insufficient pediatric pharmacokinetic and toxicity data in imposing the partial hold.

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