VANCOUVER — October 27, 2025 Leads & Copy — Bright Minds Biosciences Inc. (CSE:DRUG, Nasdaq:DRUG) rose 11.2 percent this week after securing Orphan Drug designation from the U.S. Food and Drug Administration for BMB-101, its lead serotonin agonist targeting Dravet syndrome.
An Orphan Drug designation is a special status granted by regulatory agencies—such as the U.S. Food and Drug Administration (FDA)—to encourage the development of treatments for rare diseases or conditions that affect fewer than 200,000 people in the United States.
The designation grants seven years of market exclusivity, tax credits, and priority review. BMB-101 is currently in Phase 2 trials, with interim results expected in early 2026.
CEO Ian McDonald said the company is exploring strategic partnerships to support commercialization and scale-up, citing increased interest from neurology-focused investors.
Bright Minds shares are up 39 percent year-to-date.
