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

269

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

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

19 Aug 2026

·www.prnewswire.com

Strong growth from Vyepti® and focused commercial execution drive total revenue growth of +16% CER (+13% CER underlying) in H1 2026

VALBY, Denmark, Aug. 19, 2026 /PRNewswire/ -- Key highlights Lundbeck's total revenue grew by +16% CER[1] (+11% DKK) to DKK 13,588 million in the first six months of 2026, with the U.S. and Europe delivering double-digit growth. The performance reflected continued strong commercial momentum, driven by Vyepti® and Rexulti®, and was further shaped by the transition to a partnership model in 27 markets[2], which is progressing according to plan. Adjusting for the planned one-time DKK 470 million inventory build in these markets, which occurred in the first quarter of 2026, total underlying revenue grew by +13% CER. United States: DKK 7,227 million (+20% CER; +11% DKK) Europe: DKK 3,269 million (+14% CER; +14% DKK; underlying +4% CER) International Operations: DKK 2,792 million (+6% CER; +2% DKK; underlying -1% CER) Revenue from Lundbeck's strategic brands increased by +17% CER (+11% DKK), reaching DKK 10,463 million, representing 77% of total revenue Rexulti®: DKK 3,297 million (+17% CER; +8% DKK; underlying +16% CER) Vyepti®: DKK 2,865 million (+46% CER; +36% DKK; underlying +46% CER) Brintellix®/Trintellix®: DKK 2,331 million (+0% CER; -2% DKK; underlying -5% CER) Abilify LAI franchise[3]: DKK 1,970 million (+7% CER; +4% DKK; underlying +4% CER) EBITDA increased to DKK 4,613 million, up +18% CER (+11% DKK), while adjusted EBITDA reached DKK 4,765 million, up +19% CER (+13% DKK). EBITDA growth includes the one-time gross profit impact recognized in the first quarter of 2026 from the inventory build, supporting the transition to a partnership model and future market operations. Excluding this, EBITDA increased to DKK 4,199 million, up +8% CER (+1% DKK), while adjusted EBITDA increased to DKK 4,351 million, up +10% CER (+3% DKK). The strong performance was mainly driven by Vyepti® and Rexulti®, supported by focused commercial execution. This was partially offset by higher cost of sales and higher R&D costs driven by advancing key pipeline assets. In the second quarter of 2026, adjusted EBITDA grew +6% CER, reflecting the normalization of cost phasing as R&D investment accelerated and the Q1 inventory build was a one-time effect. EPS reached DKK 2.83, increasing by +36% DKK, and adjusted EPS reached DKK 3.70, increasing by +28% DKK, reflecting the strong EBIT performance and lower financial expenses. Lundbeck President and CEO, Charl van Zyl said: "We delivered strong commercial performance in the first half of 2026, with revenue growing 16% CER, driven primarily by continued momentum for Vyepti®. Our pipeline continues to advance meaningfully, including the completion of enrollment in the DEEp OCEAN trial of bexicaserin. With a strong balance sheet and clear strategic momentum, we are entering the next phase of our strategy with confidence." Key figures Recent events On 23 July 2026, Lundbeck announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Lu AH69593, its lead oral orexin 2 receptor agonist and one of several investigational compounds in its development portfolio for sleep-wake disorders. Discovered by Lundbeck, Lu AH69593 is currently in phase Ib development for the treatment of narcolepsy. On 20 July 2026, Lundbeck announced that the last patient has been randomized in DEEp OCEAN (NCT06719141), a global phase III clinical trial evaluating the efficacy, safety and tolerability of bexicaserin for the treatment of seizures in children and adults living with developmental and epileptic encephalopathies (DEEs). On 24 June 2026, Lundbeck announced that Tarek Samad has been appointed Executive Vice President and Head of Research & Development (R&D) and will join the Executive Leadership Team (ELT) effective 1 September 2026. Tarek Samad succeeds Johan Luthman, who has informed the Board of Directors and ELT of his decision to retire after seven years with Lundbeck. On 24 June 2026, Lundbeck announced that new migraine clinical data were to be presented at the European Academy of Neurology (EAN) Congress 2026, held from 27–30 June in Geneva, Switzerland. The presentations included new analyses of eptinezumab data, exploring outcomes that reflect the broader burden of chronic migraine beyond migraine frequency alone. Lundbeck also presented phase IIb PROCEED primary data for bocunebart, an investigational treatment targeting pituitary adenylate cyclase-activating polypeptide (PACAP), which is in development for migraine prevention. On 14 June 2026, Lundbeck announced preliminary phase II Part A data from its ongoing study evaluating asedebart, an anti-adrenocorticotropic hormone (ACTH) monoclonal antibody, in adults with Cushing's disease (CD). The data were presented orally at the 2026 Endocrine Society's Annual Meeting (ENDO), held from 13–16 June in Chicago, U.S., and showed urinary free cortisol normalization in 7 out of 8 evaluable patients following individualized intravenous (IV) dose titration of asedebart. On 4 June 2026, Lundbeck announced the first presentation of primary data from the phase IIb PROCEED trial evaluating bocunebart, an investigational monoclonal antibody targeting pituitary adenylate cyclase-activating polypeptide (PACAP). The data presented at the American Headache Society Congress in Orlando, Florida, U.S. (4–7 June) support the potential of bocunebart as a preventive treatment in patients with one to four prior preventive migraine treatment failures, with particularly notable treatment effect in those with chronic migraine. On 3 June 2026, Lundbeck and Cradle, a leading AI platform for protein engineering, announced a partnership to help Lundbeck discover and optimize biotherapeutics that ultimately can improve patient outcomes. On 26 May 2026, Lundbeck announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorization for eptinezumab for use in adults with migraine. On 18 May 2026, Lundbeck announced that orphan drug designation (ODD) has been granted in Japan by the Ministry of Health, Labour and Welfare (MHLW) for asedebart for the treatment of patients with congenital adrenal hyperplasia (CAH) and Cushing's disease (CD). Conference call Today at 13.00 CET, Lundbeck will be hosting a conference call for the financial community. You can find dial-ins and a link for webcast online at under the Investor section. [1] Change at CER (Constant Exchange Rates) excludes the effect of hedging Lundbeck's foreign currency exposure. [2] For further details, see our announcement Lundbeck sharpens commercial focus in line with strategy, initiates partnering in 27 markets by end-2025 on 9 September 2025. [3] Abilify long-acting injectable (LAI) franchise comprises the following products: Abilify Maintena®, Abilify Maintena® 960 mg, and Abilify Asimtufii®. [4] Comparatives were restated to reflect the final purchase-price allocation for the Longboard business combination, for details see note 4.1 Basis of preparation. 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. Lundbeck A/S 21% more press release views with Request a Demo

Phase 2Phase 3Orphan DrugPhase 1Fast Track

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	wymrymdqrx(pjzxtfydel) = ivergkvfem yckxznelxa (zojdnqoixt ) View more	Positive	26 Jun 2026
				Eptinezumab 300 mg	hmiuxlknji(adglvupbwl) = raiavqypqe nkhmdxqznj (vxngerlhsg )
NCT05452239 (RESOLUTION, Pubmed \| J Headache Pain)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	608	Eptinezumab	xizzysgmqp(uizibllfcc) = izxxblksny oliohvcsgd (hdklsvqwjt )	Positive	13 Jun 2026
				Placebo	xizzysgmqp(uizibllfcc) = suhoyzboju oliohvcsgd (hdklsvqwjt )
NCT05570149 (EMBRACE III, Pubmed \| Neurol Ther)	Not Applicable	Migraine Disorders	124	Eptinezumab 100 mg	hnmcjukfqi(jusrlusgns) = ebivwbqptg xibicxogjs (jwcfkfjqyr ) View more	Positive	09 Jun 2026
				Eptinezumab 100 mg	hnmcjukfqi(jusrlusgns) = zatgkwkkst xibicxogjs (jwcfkfjqyr )
NCT05452239 (RESOLUTION, Pubmed \| Cephalalgia)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	602	Eptinezumab 100 mg (Brief Educational Intervention)	mvtswglwzn(ypjudstbuq) = jegvkaemwb fwjavafigu (eedcbfsdms )	Positive	01 May 2026
				Placebo (Brief Educational Intervention)	mvtswglwzn(ypjudstbuq) = dcbqhruync fwjavafigu (eedcbfsdms ) View more
NCT02985398 (PREVAIL, Pubmed \| Pain Ther)	Phase 3	Migraine Disorders	223	Eptinezumab 300 mg	kgidgvsyxs(mrpqgjvhgp) = gdzqeqobat lpuphxszxk (tsimxaxoku ) View more	Positive	17 Apr 2026
NCT04418765 (DELIVER, Pubmed \| Neurol Ther)	Phase 3	Migraine Disorders	890	Eptinezumab 100 mg	irhdsaoeke(tbdjrwrsos) = jabkbverml dxjddftbkw (tqtsknrkoi ) View more	Positive	11 Feb 2026
				Placebo	irhdsaoeke(tbdjrwrsos) = rgdmkqpqla dxjddftbkw (tqtsknrkoi ) View more
NEWS Manual	Not Applicable	Migraine Disorders	111	Eptinezumab	qxuqzleumg(zjbxeqqole) = bhyikqskdg yqwkouudkz (pvmjezkdgd ) View more	Positive	30 Jan 2026
NCT05452239 (RESOLUTION, CTgov)	Phase 4	Migraine Disorders \| Headache Disorders, Secondary	608	Eptinezumab (Placebo-controlled Period: Eptinezumab)	hixbxgcjph(ouetdbiiyr) = hwfhjnvchy wzdshycttc (mordwmepvo, 0.518) View more	-	04 Dec 2025
				placebo+eptinezumab (Placebo-controlled Period: Placebo)	hixbxgcjph(ouetdbiiyr) = xaxoaxsfnb wzdshycttc (mordwmepvo, 0.519) View more
NCT04921384 (SUNRISE, Pubmed \| Cephalalgia)	Phase 3	Migraine Disorders	978	Eptinezumab 100 mg	-	Positive	01 Oct 2025
				Eptinezumab 300 mg
RESOLUTION (PRNewswire) Manual	Phase 4	Migraine Disorders \| Headache	608	brief educational intervention (BEI) + eptinezumab	nxasmlfter(ecumzeliyy) = oxygsosadk qnblmrwggr (ohkifatisl ) View more	Positive	11 Sep 2025
				brief educational intervention (BEI) + placebo	-

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