Bexicaserin

Lundbeck is bracing for the expected U.S. loss of exclusivity for its top-selling drug Rexulti at the end of 2028. Despite falling short in its recent bid to snatch Avadel from Alkermes, Lundbeck is signaling to investors that it’s not desperate for deals and will not lower its standards for future M&A. Even as some analysts question the company’s midterm prospects following a major patent cliff, leadership says it will prioritize strategic fit and financial discipline over a quick fix.“We’re not willing to compromise,” Maria Alfaiate, Lundbeck’s EVP of corporate, portfolio and product strategy, said in an interview with Fierce Pharma on the sidelines of the J.P. Morgan Healthcare Conference 2026 in San Francisco.The biggest threat to Lundbeck’s business is perhaps the expected U.S. loss of exclusivity for Rexulti at the end of 2028. The Otsuka-partnered atypical antipsychotic is currently Lundbeck’s top-selling product, with 4.7 billion Danish kroner ($737 million) in sales for the first nine months of 2025, representing 26% year-over-year growth at constant exchange rates.Lundbeck’s own projection foretells a revenue plateau in 2029 and 2030, followed by accelerated growth if a couple of its pipeline products launch successfully, Thomas Gibbs, EVP and head of Lundbeck U.S., said. That long-term view underpins the company’s unwillingness to rush into subpar deals.“We would rather accept this plateau to then grow than actually compromise,” Alfaiate added.  Gibbs described “programmatic business development” as a key strategy, saying Lundbeck is now in a position where it does not need to pursue a large acquisition.As to the unsolicited bid for Avadel, “we do see that there could be some benefit in terms of either a late-stage or on-the-market asset to help address that 2029-2030 gap,” Gibbs said.After Alkermes increased its offer for Avadel in response to Lundbeck’s unsolicited bid, Lundbeck did not raise its price further.Buying Avadel would have given Lundbeck an immediate revenue stream from the commercial narcolepsy drug Lumryz and an earlier entry into neuro rare disease, “but not at any cost,” Alfaiate said. “Ultimately, walking away, I believe, shows discipline.”But some analysts appear more concerned about Lundbeck’s post-Rexulti life and see a more urgent need for M&A.“Lundbeck has an intriguing pipeline, however potential market entry is 2028+E, and thus will not address the impact of Rexulti LoE in 2029E,” Jefferies analysts wrote in a November note.The Danish pharma is currently banking on growth from Rexulti and its anti-CGRP migraine drug Vyepti, while two late-stage programs—multiple system atrophy candidate amlenetug and bexicaserin for epilepsy disorders—could enter the market around the 2028 timeframe.Rexulti is facing big-name competition from Bristol Myers Squibb’s Cobenfy in schizophrenia and Johnson & Johnson’s Caplyta in major depressive disorder (MDD), and Axsome Therapeutics’ Auvelity is approved in MDD and gunning for an expansion into Alzheimer’s disease agitation.Schizophrenia only makes up about 7.9% of Rexulti’s revenue, while MDD represents 35%. Acknowledging that it’s still early days, Gibbs said Lundbeck has not yet detected an impact from Caplyta’s launch since November. In both MDD and Alzheimer’s disease agitation, Gibbs argued that more products being available could raise awareness, drive diagnosis and overall market growth. Lundbeck and Otsuka recently failed to convince the FDA of Rexulti’s value as a treatment for post-traumatic stress disorder because of mixed data across three clinical trials. According to Gibbs, the pair will not pursue the indication further with another trial as the FDA has suggested.“I think the data package that we submitted was probably, in totality, the best data that have been generated for patients who haven’t responded to [selective serotonin reuptake inhibitors],” Gibbs said. “When you look at the time for payback, it just doesn’t make sense to do anything else.”In 2024, Lundbeck handed responsibilities for its older MDD drug, Trintellix, to partner Takeda. The Danish pharma made the move to “disproportionately allocate resources to our biggest growth drivers,” including Rexulti, Gibbs said, rather than a product that’s slated to lose patent protection in 2026.“As elegant as we tried to be with co-positioning, what our data and analytics suggested is that when our sales force was promoting Rexulti and Trintellix at the same time, we had a 20% less productivity in terms of our impact on Rexulti versus when it was done alone,” Gibbs said.  Following the separation, Rexulti’s year-on-year revenue growth reached 26% in the first nine months of 2025, versus 16% during the same period in 2024, without adding any new indications.As for Vyepti, the infused anti-CGRP therapy has gained traction in a market crowded with subcutaneous injectables and oral options. The drug’s sales rose 57% at constant currencies to nearly 3.3 billion Danish kroner ($518 million) in the first three quarters of 2025. Lundbeck has pegged Vyepti’s peak annual sales at more than $1.4 billion, including $1.1 billion in the U.S.Gibbs attributed Vyepti’s success to an infusion network, which helps patients navigate the entire treatment journey, as well as Lundbeck’s continued effort in building out Vyepti’s data package. The company recently rolled out real-world data suggesting that many patients may enjoy additional benefits from the infused drug following treatment with subcutaneous anti-CGRP therapy.In the pipeline, Lundbeck got bexicaserin through its $2.5 billion acquisition of Longboard Pharmaceuticals. With two phase 3 trials running in parallel in Dravet syndrome and other developmental and epileptic encephalopathy, the 5HT2C agonist is targeting a broad label and a potential market opportunity between $1.5 billion and $2 billion globally. The Longboard buyout fits Lundbeck’s focus on neuropsychiatry, neuro specialty and neuro rare disease; and according to Gibbs, any potential deals will have to fall within that bucket.“We’re not going to buy revenue,” Gibbs added. “It’s got to be a strategic fit that ideally has both revenue and a pipeline associated with it.”That means Lundbeck is not interested in obesity, despite the brain’s involvement in the disorder. Some biotechs have been looking to tackle obesity from a neurological perspective. Neurocrine Biosciences, another major neuroscience drug developer, just unveiled an obesity pipeline.“We’re a mid-size company,” Alfaiate said. “We need to be focused and follow the science in areas where we really understand the biology and where we can have the biggest impact.”“Sometimes in science, you do have some serendipity involved,” the strategy chief continued. “If that were to happen, this is probably something where we would partner with someone who knows what they’re doing, rather than trying to do it ourselves. We remain focused and dedicated to true brain health.”

New long-term data presented at AES 2025 indicate reductions in seizure frequency are maintained for up to two years after treatment initiation with bexicaserin in patients with Developmental and Epileptic Encephalopathies (DEEs)1 DEEs are a group of devastating, rare epilepsies characterized by unpredictable, drug-resistant seizures combined with developmental and intellectual disabilities2 Durable and consistent effects were observed across a diverse range of DEEs with a favorable safety and tolerability profile1 Bexicaserin is an investigational compound in development for the treatment of seizures associated with a broad range of DEEs VALBY, Denmark, Dec. 6, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced results from a long-term follow-up in patients who have received bexicaserin (LP352) for up to two years. Bexicaserin is a novel, investigational drug for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs). The data, presented at the 2025 American Epilepsy Society Congress in Atlanta, USA (Dec 5 – 9), indicate that patients who achieved an early reduction in seizure frequency following bexicaserin treatment initiation, continue to maintain this reduction long-term.1 DEEs are a group of severe, rare epilepsies that begin in childhood and demand lifelong care.2,3 Characterized by drug-resistant seizures and developmental or intellectual disabilities, these conditions leave patients heavily dependent on caregivers.3 In most cases, DEEs are resistant to conventional anti-seizure medications (ASMs) and there are currently no ASMs approved across all DEE subtypes, leaving many patients without suitable treatment options.4-6 The unpredictable nature of the seizures adds to the daily distress faced by families, highlighting the pressing need for innovative solutions to improve treatment outcomes and enhance quality of life. "The constant management of DEEs place a heavy emotional and financial burden on families, underscoring the urgent need for better seizure control. We are increasingly hopeful that bexicaserin can address this need," said Johan Luthman, EVP and Head of Research and Development at Lundbeck. "The data so far show durable seizure reductions, an encouraging safety profile and minimal risk of drug-drug interactions, reinforcing bexicaserin's potential as a first-in-class therapy across a broad range of DEEs." At the AES congress, long-term data were showcased in patients who completed the Phase 1a/2b PACIFIC trial followed by a 12-month Open Label Extension (OLE) and have now received up to two years of bexicaserin treatment via Expanded Access, which enables continued access to investigational drugs where no satisfactory alternative therapy options are available. During this two-year follow up, patients receiving bexicaserin experienced a median reduction in countable motor seizures of -60.2% at ~18 months (n=30), and -53.7% at ~24 months (n=17), compared to the start of the PACIFIC trial.1 Notably, the reductions were consistent across DEE types and similar to the results of the PACIFIC trial and OLE. This indicates that patients of all DEE types, who experience an early, clinically meaningful response, continue to maintain this response long-term.1 No new safety concerns were observed during the two-year treatment phase with a tolerability and safety profile similar to the PACIFIC trial and OLE (further safety information detailed below). The full results of the PACIFIC trial were recently published in Epilepsia, a leading neurology journal, marking a significant milestone in advancing research within the field of DEEs.7 With seven additional presentations at AES 2025, Lundbeck demonstrates the breadth of its R&D program and dedication to improving outcomes for children and families affected by rare epilepsies. Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The efficacy and safety of bexicaserin have not been established. About DEEs Developmental and Epileptic Encephalopathies (DEEs) are a group of rare neurodevelopmental disorders that typically manifest in early childhood.2 These heterogeneous and severe epilepsy syndromes are characterized by refractory seizures, frequent epileptiform activity on electroencephalogram (EEG), and developmental stagnation or regression.2 According to the International League Against Epilepsy (ILAE), DEEs currently encompass more than 10 syndromes, including Early Infantile DEE (EIDEE), Infantile Epileptic Spams Syndrome (IESS), Dravet Syndrome, and Lennox-Gastaut Syndrome with various etiologies among those mainly genetic (e.g., CDKL5, STXBP1, KCNT1, SCN2A). About bexicaserin Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no engagement of the 5-HT2B and 5-HT2A receptor subtypes, potentially minimizing the risk of cardiovascular toxicity.8 The most common TEAEs associated with bexicaserin the PACIFIC trial were somnolence, decreased appetite, constipation, diarrhea, lethargy, tremor, urinary tract infection, fatigue, pyrexia, agitation, and hypertension. Bexicaserin is being evaluated in a global Phase 3 clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with DEEs for patients two years of age and older. Bexicaserin has also recently been granted Breakthrough Therapy Designation in China for the treatment of seizures associated with DEEs. About the PACIFIC trial and 2 year Follow-Up The PACIFIC trial was a Phase 1b/2a randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, efficacy, and pharmacokinetics of bexicaserin in 52 participants between the ages of 12 and 65 years old with any type of DEE (Dravet syndrome, Lennox-Gastaut syndrome and DEE other) at 34 sites across the United States and Australia. Participants who had ≥4 countable motor seizures during the 28-day baseline period, while on a stable regimen of 1 to 4 concomitant antiseizure medications were included.7 Three participants in the bexicaserin group reported a serious adverse event (ankle fracture x 2, constipation, and increased seizures). During the titration period, 16.3% of bexicaserin-treated patients discontinued due to an adverse event, while during the maintenance period, 4.7% of bexicaserin-treated participants discontinued due to an adverse event. Following a 28-d baseline period, study participants initiated a dose titration over a 15-day period and subsequently continued on the highest tolerated dose throughout the maintenance period of 60 days. Eligible participants were given the opportunity to enroll in a 52-week open-label extension (OLE) if they completed the 75-d RCT treatment period (titration and maintenance). The OLE included patients with Dravet syndrome (n=3), Lennox-Gastaut syndrome (n=20) and DEE Other (n=18), who completed the PACIFIC trial (n=41).7 Of 38 participants who completed the OLE, 36 continued their maintenance dosing regimen via Expanded Access application. At approximately 18 months treatment (OLE + Extended Access period), one participant was lost to follow-up, and one participant was reported as deceased unrelated to study drug; the remaining 34 participants on bexicaserin received approximately 24 months of treatment.1 Contacts About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: Sylvia C, et al. Poster Presentation: American Epilepsy Congress 2025 Scheffer IE, et al. Epilepsia. 2025;00:1-10 Gallop K, et al. Epilepsy Behav. 2021;124:10824 Scheffer IE et al. Nat Rev Dis Primers 2024;10:61 Surdi P, et al. Epilepsia. 2024;65(11):3279-3292 Samanta D, et al. Epilepsy Behav. 2025;170:110472 Dlugos DJ et al. Epilepsia. Oct 24, 2025; Ren A, et al. J Medicinal Chem. 2025;68(11):10599-10618 CONTACT: H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 [email protected] This information was brought to you by Cision The following files are available for download: SOURCE H. 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