Longboard Pharmaceuticals

The 2024 Dravet Syndrome clinical trials report offers a global overview, detailing trial numbers, enrollment, and status by region, phase, and sponsor. It includes data from over 80 sources, aiding strategic decision-making. Companies like Jazz Pharmaceuticals and Sage Therapeutics are highlighted for their involvement in ongoing trials.

2024 was a stagnant year for biopharma stocks, with the iShares Biotechnology ETF (IBB) sliding 4% and the SPDR S&P Biotech ETF (XBI) dipping 0.3%. Mesoblast's FDA approval led to a 35% jump in its ADRs. Top performers included Bright Minds Biosciences (+2,615%) and Monopar Therapeutics (+1,470%), while Aditxt (-99.89%) and CNS Pharmaceuticals (-99.84%) were the biggest losers.

Beacon Biosignals presented studies using the Dreem 3S EEG headband, revealing significant sleep disturbances in Lennox-Gastaut Syndrome (LGS) patients and caregivers. Caregivers showed higher wake after sleep onset (WASO) and shorter sleep onset latency, while LGS children exhibited fewer sleep cycles and reduced REM sleep. The Dreem 3S headband demonstrated reliability in capturing high-quality, multi-night data without technologist intervention, highlighting its potential to improve neurodiagnostic research and treatment strategies for underserved populations.

Lundbeck presents data on bexicaserin, a potential treatment for Developmental and Epileptic Encephalopathies (DEEs), at the 2024 AES Annual Meeting, highlighting its Breakthrough Therapy Designation and potential to address unmet needs in severe epilepsies.

Longboard Pharmaceuticals initiated Phase III DEEp OCEAN Study of bexicaserin for treating seizures in DEEs participants aged 2-65. The global, double-blind, placebo-controlled trial aims to assess efficacy through countable motor seizures and evaluate tolerability and safety. Participants will undergo a five-week screening, three-week dose titration, and 12-week maintenance period, with an option for a 52-week open-label extension. The FDA granted breakthrough status for bexicaserin for this indication.

Longboard Pharmaceuticals initiates global Phase 3 DEEp OCEAN Study evaluating bexicaserin for seizures in Developmental and Epileptic Encephalopathies (DEEs), targeting 320 participants aged 2-65.

Longboard Pharmaceuticals reports Q3 2024 financials, including $288.4M in cash, cash equivalents, and short-term investments. The company initiated a Phase 3 global clinical trial for bexicaserin in Dravet syndrome, received FDA Orphan Drug and Rare Pediatric Disease designations, and secured a positive opinion from the EMA PDCO for a Paediatric Investigation Plan for children down to the age of 2 years. H. Lundbeck A/S agreed to acquire Longboard in a strategic deal.

Regeneron's Eylea sales miss estimates, UCB sees potential in Alzheimer's drug bepranemab, Madrigal's Rezdiffra sales exceed expectations, AbbVie partners with EvolveImmune for cancer drugs, Lundbeck acquires Longboard Pharmaceuticals, and PTC Therapeutics awaits FDA decision on Translarna for Duchenne muscular dystrophy.