Longboard Pharmaceuticals Receives FDA Designations for Bexicaserin, Targeting Dravet Syndrome

Longboard Pharmaceuticals (NASDAQ: LBPH) saw a boost in its stock price on Thursday following the U.S. FDA’s decision to grant both Rare Pediatric Disease and Orphan Drug designations for its lead candidate, bexicaserin. Bexicaserin is being developed for the treatment of Dravet syndrome, a severe form of epilepsy.

The FDA’s Rare Pediatric Disease designation offers Longboard a valuable Priority Review Voucher, which can be sold or transferred to other companies, or redeemed for fast-tracking the review of another drug. The Orphan Drug designation also provides key incentives, including tax credits for clinical trials, a waiver of marketing application fees, and seven years of marketing exclusivity in the U.S.

These designations come as Longboard prepares to launch a global Phase 3 trial for bexicaserin in the coming weeks. The company’s focus on advancing treatments for neurological diseases like Dravet syndrome continues to show promise, with the FDA’s recognition marking a significant step forward in the drug’s development.