Longboard Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Employees
- 50
- Market Cap
- $1.3B
- Introduction
Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which engages in the research and development of medicines for neurological diseases. The company was founded on January 3, 2020 and is headquartered in San Diego, CA.
Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia
• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately.
• The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026.
• Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.
Piper Sandler Initiates Buy Rating on Bright Minds' BMB-101 for Drug-Resistant Epilepsy Treatment
Analyst Yasmeen Rahimi has initiated coverage of Bright Minds Biosciences with a Buy rating, highlighting the potential of their lead compound BMB-101 for treating drug-resistant epilepsies. The G-protein biased 5-HT2C agonist has shown promising safety profiles in Phase 1 trials, with Phase 2 BREAKTHROUGH study results expected in late 2025.
Global Clinical Trials for Dravet Syndrome Reviewed in 2024
• A new report offers an overview of the clinical trial landscape for Dravet Syndrome, also known as Severe Myoclonic Epilepsy of Infancy, providing key data and analysis.
• The review includes data on trial numbers, average enrollment, and top countries involved, segmented by region, phase, status, endpoints, and sponsor type.
• Key companies like Jazz Pharmaceuticals, UCB, Takeda, and others are profiled, with details on their ongoing trials and prominent drugs in development for Dravet Syndrome.
• The report identifies trends in clinical trial enrollment over the past five years and highlights recent news related to Dravet Syndrome research and development.
Lundbeck Presents Bexicaserin Data for Developmental and Epileptic Encephalopathies at AES Annual Meeting
• Lundbeck presented data on bexicaserin, a selective 5-HT2C receptor superagonist, at the AES Annual Meeting, highlighting its potential in treating Developmental and Epileptic Encephalopathies (DEEs).
• Bexicaserin has received Breakthrough Therapy Designation from the FDA for DEEs, along with Orphan Drug and Rare Pediatric Disease Designations for Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS).
• Data presented included safety, tolerability, and efficacy results from the PACIFIC study's open-label extension, as well as preclinical data demonstrating seizure reduction in a SUDEP mouse model.
Amlenetug Receives FDA Fast Track Designation for Multiple System Atrophy
• The FDA has granted Fast Track Designation to Lundbeck's amlenetug for the potential treatment of Multiple System Atrophy (MSA).
• The designation is supported by Phase II AMULET trial outcomes and will expedite the drug development process through rolling reviews and intensive guidance.
• Amlenetug, a human monoclonal antibody, targets extracellular α-synuclein to prevent uptake and aggregation, potentially slowing MSA progression.
• Lundbeck has initiated the Phase III MASCOT trial to evaluate the efficacy, safety, and tolerability of amlenetug in MSA patients across North America, Europe, and Asia.
Bexicaserin Shows Sustained Seizure Reduction in Developmental Epileptic Encephalopathies
• Bexicaserin demonstrated a 59.3% median reduction in countable motor seizures over 12 months in patients with developmental and epileptic encephalopathies (DEEs).
• The PACIFIC open-label extension study showed consistent seizure reduction in both patients who switched from placebo to bexicaserin and those who continued treatment.
• Longboard Pharmaceuticals, now acquired by Lundbeck, is advancing bexicaserin into Phase 3 trials, including the DEEp SEA study for Dravet syndrome.
• Bexicaserin's favorable safety profile and tolerability were maintained throughout the 12-month extension, supporting its potential as a treatment for DEEs.
Longboard Pharmaceuticals Initiates Phase III Trial of Bexicaserin for Developmental and Epileptic Encephalopathies
• Longboard Pharmaceuticals has commenced the Phase III DEEp OCEAN study to evaluate bexicaserin for seizures associated with developmental and epileptic encephalopathies (DEEs).
• The global, double-blind, placebo-controlled trial will monitor countable motor seizures in approximately 320 participants aged two years and above.
• Bexicaserin, a 5-HT2C receptor superagonist, has received breakthrough status from the FDA for this indication, addressing a critical unmet need in DEE treatment.
• Eligible participants can join a 52-week open-label extension after the 12-week maintenance period, further assessing the drug's long-term safety and efficacy.
Longboard Pharmaceuticals Launches Phase 3 Trial of Bexicaserin for Developmental and Epileptic Encephalopathies
• Longboard Pharmaceuticals has initiated the Phase 3 DEEp OCEAN study to evaluate bexicaserin for seizures associated with Developmental and Epileptic Encephalopathies (DEEs).
• The DEEp OCEAN trial is a global, double-blind, placebo-controlled study involving approximately 320 participants aged two to 65 years.
• Bexicaserin, a selective 5-HT2C receptor superagonist, has received Breakthrough Therapy designation from the FDA for DEEs.
• The study aims to address a crucial unmet need in the DEE community by providing access to innovative medications and tailored clinical trials.
Longboard Pharmaceuticals Advances Bexicaserin for Dravet Syndrome
• Longboard Pharmaceuticals initiated a Phase 3 clinical trial, DEEp SEA, to evaluate bexicaserin in Dravet syndrome patients aged 2-65 years.
• Bexicaserin received Orphan Drug and Rare Pediatric Disease designations from the FDA for treating Dravet syndrome, highlighting its potential impact.
• The EMA's Paediatric Committee issued a positive opinion on the Paediatric Investigation Plan for bexicaserin in children as young as two years old.
• Lundbeck A/S is set to acquire Longboard, marking a strategic move to further develop novel neurological disease treatments.
Longboard Pharmaceuticals Initiates Phase 3 Trial of Bexicaserin for Dravet Syndrome
• Longboard Pharmaceuticals has started a Phase 3 clinical trial, DEEp SEA, to assess bexicaserin in Dravet syndrome patients aged 2-65 years.
• Bexicaserin, a selective 5-HT2C receptor superagonist, continues to show sustained seizure reduction and a favorable safety profile in DEEs.
• The FDA granted Orphan Drug and Rare Pediatric Disease designations to bexicaserin for treating Dravet syndrome, highlighting its potential impact.
• H. Lundbeck A/S is set to acquire Longboard, a strategic move following positive developments in bexicaserin's clinical program.
Regeneron Faces Eylea Uncertainty; Madrigal's Rezdiffra Exceeds Expectations
• Regeneron's shares declined due to concerns over Eylea sales, despite hopes for new drugs targeting blood clots, lung cancer, and obesity to revitalize growth.
• Madrigal Pharmaceuticals' Rezdiffra, a MASH treatment, significantly surpassed sales forecasts, with $62 million in sales reported for the third quarter.
• UCB's bepranemab, an Alzheimer's drug, showed promising signs of slowing cognitive decline in a mid-stage trial, despite missing its primary endpoint.
• AbbVie is collaborating with EvolveImmune Therapeutics to develop multispecific antibody drugs for cancer, providing $65 million upfront with potential for $1.4 billion more.
Epilepsy Pipeline Shows Promise with Novel Therapies in Clinical Trials
• Over 90 epilepsy treatment therapies are under development by more than 75 companies globally, targeting various mechanisms of action and routes of administration.
• Longboard Pharmaceuticals reported positive Phase Ib/IIa results for LP352 (bexicaserin) in developmental and epileptic encephalopathies (DEEs), showing a significant reduction in seizure frequency.
• Amzell has initiated a study comparing AMZ002 with Vigabatrin for treating infantile spasms, a rare and severe form of epilepsy, to assess efficacy and safety.
• Emerging therapies like RLS103, CT-010, Darigabat, and XEN496 are in different clinical trial phases, indicating potential advancements in epilepsy management.
Lundbeck to Acquire Longboard Pharmaceuticals for $2.6 Billion, Bolstering Epilepsy Pipeline
• Lundbeck will acquire Longboard Pharmaceuticals for $2.6 billion, gaining bexicaserin, a promising drug for developmental and epileptic encephalopathies (DEEs).
• Bexicaserin, a 5-HT2C receptor superagonist, has shown encouraging results in clinical trials for reducing seizure frequency in Dravet syndrome and other DEEs.
• The acquisition aligns with Lundbeck's strategy to expand its neuro-rare disease portfolio, with bexicaserin potentially launching in 2028 and reaching peak sales of $1.5-2 billion.
• The deal is expected to close in the fourth quarter of 2024, pending regulatory approvals and tender of Longboard's outstanding shares.
Lundbeck to Acquire Longboard Pharmaceuticals for $2.6 Billion, Bolstering Dravet Syndrome Pipeline
• Lundbeck announces a definitive agreement to acquire Longboard Pharmaceuticals for $2.6 billion in cash, expanding its neuroscience portfolio.
• The acquisition is driven by Longboard's promising pipeline, particularly its Phase 3-ready drug, bexicaserin (LP352), for Dravet syndrome.
• Bexicaserin, a novel, centrally acting, selective 5-HT2A receptor agonist, has shown potential in reducing seizure frequency in Dravet syndrome patients.
• The deal signifies Lundbeck's strategic focus on innovative therapies for severe neurological disorders with significant unmet medical needs.
Longboard Pharmaceuticals Launches Phase 3 Trial of Bexicaserin for Dravet Syndrome
• Longboard Pharmaceuticals has initiated a global Phase 3 trial, DEEp SEA, to evaluate bexicaserin for treating seizures associated with Dravet syndrome.
• The study will enroll approximately 160 participants aged 2 to 65 and assess the efficacy and safety of bexicaserin over a 12-week maintenance period.
• Bexicaserin has received Orphan Drug and Rare Pediatric Disease designations from the FDA, providing incentives for its development as a Dravet syndrome treatment.
• Previous Phase 1b/2a trial data showed significant reductions in seizure frequency among Dravet syndrome patients treated with bexicaserin.
Longboard's Bexicaserin Shows Sustained Seizure Reduction in DEE Patients
• Longboard Pharmaceuticals' bexicaserin demonstrated a 57.7% median reduction in countable motor seizures over nine months in DEE patients.
• The PACIFIC OLE study showed consistent seizure reduction in both bexicaserin-treated and placebo-to-bexicaserin groups.
• Bexicaserin exhibited a favorable safety and tolerability profile, with a high retention rate of 92.7% in the open-label extension study.
• Longboard plans to initiate a global Phase 3 program for bexicaserin, which has received Breakthrough Therapy designation.
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