Longboard Pharmaceuticals

Longboard Pharmaceuticals received Rare Pediatric Disease and Orphan Drug designations from the FDA for bexicaserin (LP352) in Dravet syndrome, following a Breakthrough Therapy designation for seizures associated with DEEs. The company plans to initiate its global Phase 3 DEEp program for Dravet syndrome.

Longboard Pharmaceuticals reported interim results from its 52-week open-label extension of the Phase II PACIFIC Study, showing a median 57.7% decrease in countable motor seizure frequency across 40 participants with developmental and epileptic encephalopathies (DEEs). The study assessed bexicaserin's safety, tolerability, and impact on seizure frequency, with consistent results regardless of initial treatment. A high retention rate of 92.7% was noted, and the company plans to provide a full analysis with 12-month data next year.

Bexicaserin's US revenue forecasted at $596 mn by 2036. Longboard Pharmaceuticals develops LP-352 for neurological disorders, with an operating loss of $44.8 mn in FY2022. GlobalData's rNPV model considers drug failure risk in clinical development.

Bexicaserin showed a 57.7% median seizure reduction in DEEs over 9 months, with favorable safety and tolerability. Data to be presented at the 15th European Epilepsy Congress in Rome, Italy. Full 12-month OLE dataset expected early next year.

Longboard Pharmaceuticals announced positive interim results from the PACIFIC Study OLE, showing a 57.7% median reduction in countable motor seizures over ~9 months for bexicaserin in DEEs, with sustained efficacy and a favorable safety profile. The company plans to initiate a global Phase 3 program later this year.