EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting > 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.

Start Date30 Sep 2026

Sponsor / Collaborator

Sunnybrook Health Sciences Centre

ISRCTN59164978

/ RecruitingPhase 3IIT

Eptinezumab for the acute treatment of status migrainosus in the emergency department of a community hospital

Start Date27 Jul 2026

Sponsor / Collaborator

Centre Hospitalier de l'Universite de Montreal

NCT07655440

/ Not yet recruitingPhase 4IIT

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Many people with migraine also experience tinnitus - a persistent ringing, buzzing, or hissing in the ears - and research suggests these conditions share underlying biological mechanisms, including a protein called calcitonin gene-related peptide (CGRP) that is active in both the brain and the inner ear. COMPACT-PM is a randomized trial comparing two classes of migraine preventive medications in adults with bothersome tinnitus and a history of migraine: anti-CGRP therapies (newer injectable or oral agents that block CGRP or its receptor) versus conventional migraine preventives (antidepressants including amitriptyline, nortriptyline, and venlafaxine; antihypertensives including propranolol, verapamil, and candesartan; and the anticonvulsant topiramate). Participants are randomly assigned - like a coin flip - to one of the two treatment groups; neither group receives a placebo, as both receive active migraine treatment. The study's primary outcome is change in the Tinnitus Functional Index (TFI) over 24 weeks, with additional measures including hearing tests, balance assessments, auditory brainstem response testing, and a comprehensive symptom diary. The study is conducted at the Stanford Ear Institute and is funded by a philanthropic gift to the Department of Otolaryngology - Head & Neck Surgery at Stanford University.

Start Date01 Jul 2026

Sponsor / Collaborator

Stanford University

100 Clinical Results associated with Eptinezumab-JJMR

100 Translational Medicine associated with Eptinezumab-JJMR

100 Patents (Medical) associated with Eptinezumab-JJMR

270

Literatures (Medical) associated with Eptinezumab-JJMR

01 Jul 2026·CEPHALALGIA

Cerebrovascular risk with calcitonin gene-related peptide monoclonal antibodies versus onabotulinumtoxinA in patients with migraine: A real-world pharmacoepidemiologic study in the National Institutes of Health All of Us Research Program

Article

Author: Ong, Bradley ; Thompson, Nicolas ; Gül, Sedat ; Trudeau, Stephen ; Yuan, Hsiangkuo

Aim:

To evaluate whether initiation of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) was non-inferior to initiation of onabotulinumtoxinA with respect to the hazard of ischemic stroke or transient ischemic attack (IS + TIA) in a real-world cohort of adults with migraine.

Methods:

We conducted a retrospective, active-comparator, new-user pharmacoepidemiology study using the NIH All of Us Research Program Registered Tier Dataset (v8). Adults with migraine initiating CGRP mAbs (erenumab, fremanezumab, galcanezumab, eptinezumab) were compared with initiators of onabotulinumtoxinA from January 2018 through September 2023. The primary outcome was IS + TIA occurring more than 90 days after treatment initiation. Inverse probability of treatment weighting (IPTW) with stabilized propensity scores was used to adjust for 23 baseline covariates. Non-inferiority was assessed on the hazard ratio (HR) scale using a prespecified margin of 1.5, with non-inferiority concluded if the upper bound of the 95% confidence interval (CI) was less than 1.5. Prespecified subgroup analyses included migraine with aura and without aura. Prespecified sensitivity analyses included a per-protocol analysis, a crossover-excluded analysis, and an IS-only analysis. Fracture was used as a negative control outcome.

Results:

Among 16,147 patients with migraine in the cohort, the primary comparison included 1,581 CGRP mAb initiators and 947 onabotulinumtoxinA initiators. IPTW achieved a good covariate balance for the primary comparison (maximum standardized mean difference 0.016). For the primary outcome, 14 IS + TIA events occurred among CGRP mAb initiators and 22 among onabotulinumtoxinA initiators. The hazard ratio for IS + TIA was 0.524 (95% CI 0.263–1.046), which met the prespecified statistical criterion for non-inferiority because the upper confidence bound was below 1.5; however, the estimate was imprecise because of the small number of events. In the migraine with aura subgroup, the estimate also met the non-inferiority criterion (HR 0.419, 95% CI 0.163–1.080), whereas the migraine without aura subgroup, per-protocol analysis, and major adverse cardiovascular events analysis were inconclusive for non-inferiority. For major adverse cardiovascular events the HR was 1.068 (95% CI 0.589–1.935). The fracture negative control was also not significantly different (HR, 1.175; 95% CI, 0.692–1.993; p = 0.551), arguing against systematic healthy-user confounding. A formal adjusted comparison with untreated patients was not feasible due to structural confounding inherent to the stepped-care treatment pathway.

Conclusions:

In this real-world diverse cohort, initiation of CGRP mAbs met the prespecified statistical criterion for non-inferiority relative to onabotulinumtoxinA for the primary IS + TIA outcome. However, this finding was based on few events and wide CIs and should be interpreted cautiously as limited evidence against a large relative increase in incident IS + TIA risk, rather than as definitive evidence of equivalent safety, absence of modest harm, or a protective effect. Several secondary, subgroup, and supportive analyses remained inconclusive for non-inferiority. Larger adequately powered comparative safety studies are needed.

09 Jun 2026·NEUROLOGY

Glaucoma Risk Associated With Calcitonin Gene–Related Peptide Inhibitor Use in Migraine

Article

Author: Weng, Chien-Hsiang ; Wu, Jr-Wei ; Wang, I-Jong ; Lin, Hui-Ju ; Pan, Ssu-Yu ; Chou, Chien-Chih

BACKGROUND AND OBJECTIVES:

Migraine has been linked to an increased risk of glaucoma, and our study aims to assess the temporal association between calcitonin gene-related peptide inhibitors (CGRPi) and the risks of glaucoma in individuals with migraine.

METHODS:

This multinational retrospective cohort study included adults diagnosed with migraine who received migraine preventive medications in 2018-2024. Participants were categorized into the CGRPi group (erenumab, fremanezumab, galcanezumab, eptinezumab, atogepant, or rimegepant) and non-CGRPi group (valproate, topiramate, flunarizine, candesartan, lisinopril, metoprolol, propranolol, nadolol, amitriptyline, and venlafaxine). Crossovers were not allowed, and the non-CGRPi group included only individuals who never used CGRPi. The CGRPi and non-CGRPi groups were propensity score matched in a 1:1 ratio and were followed for up to 3 years to monitor the occurrence of incident glaucoma. The Cox proportional hazards model was used to compare the risk of glaucoma between CGRPi and non-CGRPi users, with results reported as hazard ratios (HRs) and 95% CIs.

RESULTS:

A total of 73,644 individuals were included in the final analysis. Compared with non-CGRPi users, CGRPi users experience a lower risk of glaucoma development (HR 0.75; 95% CI 0.61-0.92) within 3 years since its first prescription. Individuals using CGRPi also exhibit a reduced risk of glaucoma compared with those using topiramate (HR 0.73; 95% CI 0.59-0.90), valproate (HR 0.54; 95% CI 0.35-0.83), propranolol (HR 0.76; 95% CI 0.59-0.98), metoprolol (HR 0.76; 95% CI 0.59-0.98), lisinopril (HR 0.49; 95% CI 0.38-0.62), amitriptyline (HR 0.69; 95% CI 0.54-0.89), and venlafaxine (HR 0.68; 95% CI 0.50-0.91). In the analysis that further classified participants based on the specific CGRPi used, only users of monoclonal antibody CGRPi show a reduced risk of glaucoma compared with non-CGRPi users (HR 0.77; 95% CI 0.61-0.98). The reduced risk of glaucoma associated with CGRPi is also observed in older adults, women, and those with chronic migraine or migraine without aura.

DISCUSSION:

Among adults with migraine receiving preventive treatment, systemic use of CGRPi, particularly monoclonal antibody CGRPi, is associated with a reduced risk of glaucoma compared with the use of other migraine preventive medications.

CLASSIFICATION OF EVIDENCE:

This is a Class II study demonstrating that CGRPi users with migraine have a lower risk of incident glaucoma when compared with non-CGRPi users with migraine.

01 Jun 2026·Pain and Therapy

Long-Term Reductions in Headache Frequency, Severity, and Disability with Eptinezumab in Adults with Chronic Migraine: Results from the PREVAIL Trial

Article

Author: Grossman, S Wald ; Kudrow, David ; Kapur, Neha ; Patel, Foram ; Starling, Amaal J ; Blumenfeld, Andrew ; Lipton, Richard B ; Ailani, Jessica ; Awad, Susanne F

INTRODUCTION:

Individuals with chronic migraine (CM) experience substantial headache-related disability. Post hoc analyses from the PREVAIL trial assessed the long-term impact of eptinezumab preventive treatment for CM on patient-centered measures of headache frequency, headache pain severity, disability, and quality of life.

METHODS:

In the 104-week, open-label PREVAIL trial, which evaluated long-term safety and patient-reported outcomes, participants received eptinezumab 300 mg intravenously every 12 weeks to week 84 for preventive treatment of CM. The Migraine Disability Assessment (MIDAS) scale was used to evaluate proportions of participants with sustained ≥ 50% and ≥ 75% reductions in mean monthly headache days (MHDs) through 12-week dosing intervals to week 84 and changes in mean MHD frequency category (e.g., 0, 1- < 4 MHDs), Frequency-Severity Index (FSI) scores (composite of MIDAS-derived mean MHDs and headache pain severity), and days with headache-related disability through week 104.

RESULTS:

Over half of participants with ≥ 50% or ≥ 75% reduction in mean MHDs after the first eptinezumab dose (weeks 1-12: 78% and 54%, respectively) or second dose (weeks 13-24: 83% and 69%, respectively) experienced sustained reductions in headache frequency through all subsequent dosing intervals until the last dose (week 84). At baseline, participants reported a mean (standard deviation [SD]) of 15.8 (7.6) MHDs. More than 60% of participants reported < 4 mean MHDs at week 12 and at all subsequent assessments through week 104 (20 weeks after last infusion) after initiating eptinezumab; 23% reported 0 mean MHDs by week 104. The mean FSI score decreased from baseline (11.4) to week 12 (3.5), with decreases maintained through week 104. Monthly days with headache-related impact also decreased from baseline to week 12, with improvements maintained through week 104.

CONCLUSIONS:

Treatment with eptinezumab 300 mg is associated with substantial early and long-term reductions in headache frequency, severity, and disability, indicating its ability to improve multiple aspects of the broader burden of CM. Graphical abstract available for this article.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT02985398.

News (Medical) associated with Eptinezumab-JJMR

16 Sep 2026

·www.prnewswire.com

Lundbeck receives marketing authorization for Vyepti® (eptinezumab) in Japan for the prevention of migraine attacks

Approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW) Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment approved for the prevention of migraine attacks in adults and launched in over 30 countries worldwide Authorization supported by the Phase III SUNRISE trial and the SUNSET long-term extension study in Japanese patients Building on 25 years of commitment to patients and brain health in Japan, the approval paves the way for Lundbeck's first launch in Japan as Marketing Authorization holder, enabling Lundbeck to operate independently on the Japanese market VALBY, Denmark, Sept. 16, 2026 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has granted marketing authorization for eptinezumab for the prevention of migraine attacks in adults, marking an important milestone for patients in Japan and for Lundbeck's continued growth in Asia. Migraine is a debilitating neurological disease characterized by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound. In Japan, migraine affects an estimated 8.4%–11.0% of the population1 and is the fourth leading cause of years lived with disability.2 Beyond the physical symptoms, migraine significantly affects daily functioning, quality of life, work productivity and life course.2 Migraine is estimated to cost the Japanese economy US$ 3 billion every year in lost productivity.3 "This approval represents a significant advancement for people living with migraine in Japan, where the disease continues to place a substantial burden on patients, families, and society," said Tarek Samad, EVP and Head of Research and Development at Lundbeck. "Eptinezumab is a differentiated IV CGRP-targeted therapy that offers adults living with migraine an important new treatment option, and we are proud to bring this innovative medicine to patients in Japan. This approval also marks an exciting new chapter for Lundbeck Japan as we prepare for our first independent launch, building on 25 years of commitment to patients and brain health in the country." Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and was developed for IV administration as a preventive treatment for migraine. The Japanese marketing authorization is supported by the global clinical development program for eptinezumab, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, together with data from the Phase III SUNRISE trial, which evaluated efficacy and safety in a predominantly Asian population with chronic migraine.4 The application was further supported by the Phase III SUNSET long-term extension study conducted specifically in Japanese patients to evaluate the long-term safety of eptinezumab.2 Eptinezumab was first approved by the U.S. Food and Drug Administration in 2020 for the preventive treatment of migraine in adults, followed by additional approvals including in the European Union and most recently South Korea. It has since been launched in more than 30 markets worldwide. About migraine Migraine is a complex and disabling neurological disease characterized by recurrent attacks of severe headache typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also imposes both a social and financial burden. Migraine can have a profound impact on daily functioning, work productivity, family and social relationships and quality of life. Migraine is one of the most prevalent neurological diseases worldwide and remains a leading cause of disability, particularly among people under the age of 50.5,6 As migraine frequency and severity increase, attacks may become harder to control, contributing to greater disease burden and, without appropriate preventive management, progression to chronic migraine.7 About Vyepti® (eptinezumab) Eptinezumab is a humanized mAb that binds to CGRP which was designed for IV administration. The efficacy and safety of eptinezumab were evaluated in two Phase III clinical trials, PROMISE-1 in episodic migraine8 and PROMISE-2 in chronic migraine.9 In both trials, eptinezumab met its primary endpoint of decrease in monthly migraine days (MMDs) over weeks 1-12. The safety of eptinezumab has been evaluated in more than 5,000 adult patients with migraine who received at least one dose. Common adverse reactions in the placebo-controlled clinical trials for the preventive treatment of migraine were hypersensitivity and infusion-related reactions. VYEPTI® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. In Japan, eptinezumab is approved for the prevention of migraine attacks in adults. Today, eptinezumab is launched in more than 30 markets worldwide. 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: Sakai F, Igarashi H. Cephalalgia. 1997;17(1):15-22 Takeshima T, et al. J Headache Pain. 2025;26(1):275 Sakai F (2010) Olesen J, Ramadan N (eds) Headache care, research and education worldwide, vol 17. Oxford University Press, New York, pp 35–40 Yu S, et al. Cephalalgia. 2025;45(10):3331024251386095 Steiner TJ, et al. J Headache Pain. 2018;19(1):17 Leonardi M, et al. J Headache Pain. 2005; 6(6):429– 440 Lipton RB, et al. J Neurol. 2023;270(12);5692–5710 Ashina M, et al. Cephalalgia. 2020;40(3):241-254 Lipton RB, et al. Neurology. 2020;94(13):e1365-e1377 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: 21% more press release views with Request a Demo

Phase 3Drug ApprovalClinical Result

24 Aug 2026

·www.fiercepharma.com

Lundbeck strikes expanded pact with Eversana to broaden AI scope across US commercial business

A year after unveiling its AI Agency platform, Eversana has reeled in its first publicly named pharma partner with brain disease specialist Lundbeck signing on to use the AI commercialization digs across its U.S. commercial organization. Lundbeck is going all in on Eversana’s AI agency platform after initially deploying the company’s AI-driven workflows across strategic planning, content development and commercial execution, Eversana explained in an Aug. 25 release. Now, the drugmaker will expand its AI usage to more areas including marketing, medical communications, market access and media operations, as well as explore “additional use cases” with Eversana that could also boost operational performance. "What makes this partnership unique is that we're not simply introducing AI tools into existing workflows," Eversana’s chief innovation officer Faruk Capan said in the release. "Together, we're implementing an AI-powered operating model designed specifically for life sciences. By combining agentic AI, embedded compliance and human expertise, we can help commercial teams accelerate execution while maintaining the quality and scientific rigor the industry demands." Lundbeck, for its part, is looking to build its “bionic capabilities” as a key spoke of how it advances its Focused Innovator R&D strategy, the company’s U.S. EVP and president Tom Gibbs added. By expanding its collaboration with Eversana, Lundbeck can further “scale bionic capabilities responsibly across our commercial organization, improve the speed and quality of execution and ultimately, help us deliver greater value to our customers and patients while maintaining the high standards that define our business,” he said. Eversana’s AI agency is an end-to-end AI-powered commercialization platform that was built with Google Cloud technology. The agency merges together agentic AI, advanced automation and human expertise to foster a scalable framework for strategy development, content creation and omnichannel engagement, according to the release. In other words, Eversana is zeroed in on “pharmatizing AI,” CEO Mark Thierer told Fierce in an interview, “with a focus on patients.” To do so, the company has built the “AI hub of the future,” Thierer said. As Thierer puts it, the pharmaceutical industry is at a point where companies “have got to find new ways of doing business,” pointing to industry-wide patent cliffs and sweeping financial pressure across the board. AI capabilities, the CEO suggests, could be the answer. “What we’re creating is a new way for pharma to do business, spanning marketing, sales, all the way through product launch,” Thierer explained. “Pharmatizing AI is a competitive set of weapons for pharma to win market share, and in the end, get patients on the appropriate therapy.” Thierer is a veteran healthcare leader who spent years as Eversana’s board chairman before taking the CEO reigns upon Eversana’s merger with his digital health company Waltz Health last year. While the wider Eversana company focuses on integrated commercial services, its specialized AI Agency is the first of its kind. With now a year of operations and expansions under its belt, Thierer figures that while others will “catch up over time,” competitors will have to “run fast, because we’re way ahead at this point,” he said. The AI wave continues to touch every corner of the industry, with pharmas big and small deploying the technology for intelligent R&D, assistive workflow help , commercial and corporate operations and more. Eversana’s toolkit builds on a longstanding collaboration with Google and is unique in that it is “not comparable to just using AI tools to enhance copywriting or content creations,” Capan said in a release upon launch last year. Lundbeck’s CEO Charl van Zyl recently told Fierce that the company is capable of “punching above its weight” as a “neuroscience challenger” as the drugmaker continues to build on the momentum of migraine med Vyepti and Otsuka-partnered atypical antipsychotic Rexulti, which drove sales growth of 16% over the first half of the year. When Lundbeck signed on to use Eversana’s AI Agency platform across its U.S. commercialization operations, the company was equally signing up to become a more competitive force, “all the way from marketing to the distribution of product,” Thierer commented. “AI is on the desk of every C-suite member of every pharmaceutical company and services company alike,” Thierer said. “Executives are thinking about how to do this, and we’ve emerged as a partner that can help them.”

21 Aug 2026

·www.fiercepharma.com

Lundbeck continues neuroscience evolution as CEO keeps company ‘punching above its weight’

Almost three years into his tenure as Lundbeck’s CEO, Charl van Zyl is confident the company can prove its mettle as a “neuroscience challenger” capable of “punching above its weight.” This newfound momentum continued to play out over the first half of 2026, when Lundbeck reported sales growth of 16%. It is being sustained by brands like Vyepti and the Otsuka-partnered Rexulti, a series of near-term clinical readouts and a constant “acquisitive” disposition to pounce on innovation both within the company and beyond, van Zyl told Fierce in an interview. By the numbers, Rexulti, approved in major depressive disorder (MDD) and Alzheimer’s disease-associated agitation, continued to lead the pack for the earnings period, growing 17% at constant currencies over the first six months of the year to 3.3 billion Danish kroner (nearly $515 million), while migraine prevention med Vyepti climbed an impressive 46% to reach 2026 first-half sales of 2.9 billion kroner ($447 million). Van Zyl described Lundbeck’s overall sales momentum as “healthy growth for us.” While the company remains on track to meet the raised guidance (PDF) it issued after the first quarter, van Zyl did caution that commercial inventory buildouts from the first half of the year won’t repeat in the second, and he added that generic entrants to the company’s atypical antipsychotic Abilify Maintena—particularly in Canada and Australia—could start to chip away at sales in the final six months of 2026. Nevertheless, van Zyl appeared confident that Lundbeck’s two core products are positioned to continue holding their own. The company currently expects that Vyepti could reel in peak U.S. sales of $1.1 billion, per the CEO, who noted that commercial opportunities are starting to come online in regions like Europe, alongside plans to launch into China, Japan and South Korea next year. Rexulti is also growing well across its indications, though “that will naturally slow down” as competition in those fields increases—as Lundbeck has itself telegraphed—van Zyl added. In late April, the FDA approved Axsome’s Auvelity as the second drug in the U.S. to treat agitation associated with dementia caused by Alzheimer’s disease. Auvelity also boasts an FDA nod in MDD, positioning it as a direct rival to Lundbeck’s drug. Rising to the challenge While long known for its psychiatric drug development bona fides, Lundbeck has in more recent years pivoted to other indications “where we believe we understand the biology of neuroscience more,” van Zyl said. The CEO admitted that psychiatry treatments can be “challenging sometimes” due to trial design and the placebo effect. That has led to a foray for Lundbeck into “neurospeciality,” he explained, highlighting areas like preventative migraine—a field that has proven highly fruitful for Vyepti—in the near term, plus future opportunities in niches like Parkinson’s disease and beyond. Elsewhere, Lundbeck is also exploring rare neurological diseases, with van Zyl noting that the company aims to position itself as a true “neuroscience challenger.” “You know, mid-cap and punching above its weight,” he explained, adding that Lundbeck is further prioritizing innovation “in the sense that we will not develop anything that’s ‘me-too.’” That ever-expanding R&D focus also covers moves beyond the firm’s prior bread-and-butter small molecules and, more recently, monoclonal antibodies, as Lundbeck pursues development of other modalities, too. That said, the company these days is doing “a little steering away from gene therapy,” van Zyl caveated, adding that there are “still many questions” around that therapeutic approach. Among the company’s most advanced assets, 5-HT2C receptor agonist bexicaserin, acquired in Lundbeck’s 2024 acquisition of Longboard Pharmaceuticals, is being aimed at severe childhood epilepsies, with two late-stage studies—DEEp Ocean and DEEp Sea—slated to read out in the fourth quarter of 2026 and the first quarter of 2027, respectively. Should those readouts prove successful, Lundbeck is eyeing a potential approval for the drug sometime in 2028, van Zyl said. That would give the company time to find its commercial footing with a new drug “so that we are well on our way by 2029 and growing into the next decade with this asset,” he added. Slightly further afield, the company is anticipating a phase 3 readout on its multiple system atrophy contender amlenetug at the end of 2027, the CEO said. Also part and parcel of Lundbeck’s strategy is “to be acquisitive,” van Zyl said, noting that “we look very much at external and internal innovation and business development that makes sense for us.” The Longboard buyout continues to serve as a guidepost for the types of deals Lundbeck wants to forge, van Zyl said. The CEO described that deal as a “string of pearls”—referring to bolt-on assets like bexicaserin—and Lundbeck will continue to hunt for similar transactions in the $1.5 billion to $2 billion ballpark, he said. Beyond that, Lundbeck is also constantly assessing targets that could bring both revenue and innovation onboard, and for those deals, the company is more comfortable spending in the $2 billion to $3 billion range. “A good biopharma strategy is one of constantly searching,” van Zyl said.

AcquisitionDrug ApprovalPhase 3

100 Deals associated with Eptinezumab-JJMR

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KEGG	Wiki	ATC	Drug Bank
D11303	Eptinezumab-JJMR	L01XC	DB14040

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	Lundbeck Seattle BioPharmaceuticals, Inc.	21 Feb 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Headache	Phase 3	-	H. Lundbeck A/S	22 Jun 2026
Pseudotumor Cerebri	Phase 3	-	H. Lundbeck A/S	22 Jun 2026
Headache caused by drug	Phase 3	United States	H. Lundbeck A/S	17 Feb 2021
Headache caused by drug	Phase 3	South Korea	H. Lundbeck A/S	17 Feb 2021
Headache caused by drug	Phase 3	Spain	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	United States	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	China	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	South Korea	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Spain	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Taiwan Province	H. Lundbeck A/S	17 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EAN2026	Not Applicable	Migraine Disorders	201	Eptinezumab 100 mg	kpahbspeku(qaodxbimdi) = ctrpoaorhr jecsbnwopn (owllgetndp ) View more	Positive	26 Jun 2026
				Eptinezumab 300 mg	hziaudeonl(acmqtdpaem) = lqszquhwqy ixdxnccwjj (mfttcmoowc )
NCT05452239 (RESOLUTION, Pubmed \| J Headache Pain)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	608	Eptinezumab	oubxfdrohe(cgpajgmque) = oeyetxbuqr hvcddvwatm (elfoiyazvp )	Positive	13 Jun 2026
				Placebo	oubxfdrohe(cgpajgmque) = qciiucenlg hvcddvwatm (elfoiyazvp )
NCT05570149 (EMBRACE III, Pubmed \| Neurol Ther)	Not Applicable	Migraine Disorders	124	Eptinezumab 100 mg	qydddwohbu(czzazyypqs) = yloevusyqm qsvrdtlark (pvudtqnsvx ) View more	Positive	09 Jun 2026
				Eptinezumab 100 mg	qydddwohbu(czzazyypqs) = wjpnybsikq qsvrdtlark (pvudtqnsvx )
NCT05452239 (RESOLUTION, Pubmed \| Cephalalgia)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	602	Eptinezumab 100 mg (Brief Educational Intervention)	nfgllbppov(lmpdctmgzx) = mqsyyodcxh uorprhhuki (zlpbxtncyz )	Positive	01 May 2026
				Placebo (Brief Educational Intervention)	nfgllbppov(lmpdctmgzx) = zezfyvnymv uorprhhuki (zlpbxtncyz ) View more
NCT02985398 (PREVAIL, Pubmed \| Pain Ther)	Phase 3	Migraine Disorders	223	Eptinezumab 300 mg	rttmfglczw(bkuktkykpd) = ppplinzyom nlinjrsyyc (qzwhqjjmzd ) View more	Positive	17 Apr 2026
NCT04418765 (DELIVER, Pubmed \| Neurol Ther)	Phase 3	Migraine Disorders	890	Eptinezumab 100 mg	ukkriavafi(cbxzdeqlek) = qaemdyogau qprfxawfhn (cchboitzzt ) View more	Positive	11 Feb 2026
				Placebo	ukkriavafi(cbxzdeqlek) = cbrpbzutik qprfxawfhn (cchboitzzt ) View more
NEWS Manual	Not Applicable	Migraine Disorders	111	Eptinezumab	gcagpljnlv(xmrpqxkpce) = mwrsindvse dczdqbwiuq (axsffosvqx ) View more	Positive	30 Jan 2026
NCT05452239 (RESOLUTION, CTgov)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	608	Eptinezumab (Placebo-controlled Period: Eptinezumab)	xsjnuipyha(xtehccyyon) = urihitzdzs zcopyczvqj (kjqjlwjmal, 0.518) View more	-	04 Dec 2025
				placebo+eptinezumab (Placebo-controlled Period: Placebo)	xsjnuipyha(xtehccyyon) = nffrlxuuga zcopyczvqj (kjqjlwjmal, 0.519) View more
NCT04921384 (SUNRISE, Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	978	Eptinezumab 100 mg	-	Positive	01 Oct 2025
				Eptinezumab 300 mg
NCT05064371 (SUNSET, PRNewswire) Manual	Phase 3	Migraine Disorders	159	Eptinezumab 100 mg	thvevgofpr(tgmeogalbz) = osltrwebda nvzcwffekj (tbwncbgbdg )	Positive	11 Sep 2025
				Eptinezumab 300 mg	-

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