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Overview
Lundbeck is a global pharmaceutical company that focuses on brain health. It develops and markets prescription medicines for central nervous system (CNS) disorders such as depression, schizophrenia, and other brain diseases, using its in-house research and development to advance its pipeline. Its products work by altering brain chemistry or signaling to reduce symptoms and improve function, delivered in standard medical formats like oral tablets or other approved forms. Lundbeck differentiates itself through a specialized focus on neuroscience, a long-standing commitment to R&D, and a strong, founder-aligned foundation that supports long-term scientific work rather than short-term gains. Its goal is to restore brain health and improve quality of life for people with neurological and psychiatric conditions by advancing neuroscience and delivering effective therapies globally.
About Lundbeck
Industries
Biotechnology
Healthcare
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Copenhagen, Denmark
Founded
1915
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Simplify's Take
What believers are saying
- Q1 2026 revenue rose 21%, and Lundbeck raised full-year guidance to 7-9%.
- Vyepti grew 47% and Rexulti 22%, proving commercial momentum in core brands.
- Lu AH69593’s Fast Track and phase 1b progress create a credible new pipeline option.
What critics are saying
- Trintellix patents expire June 2026, creating a near-term cliff for a major franchise.
- Rexulti faces generic pressure after 2028, threatening one of Lundbeck’s biggest revenue engines.
- 602 jobs vanished across 27 markets in 2025, signaling ongoing restructuring risk and complexity.
What makes Lundbeck unique
- Lundbeck’s 2026 focus is brain health, with Vyepti and Rexulti driving growth.
- FDA Fast Track for Lu AH69593 validates its orexin wakefulness platform in narcolepsy.
- Cradle AI partnership and Gefion access deepen Lundbeck’s biologics discovery capabilities.
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Funding
Total Funding
$770M
Above
Industry Average
Funded Over
1 Rounds
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6 month growth
↑ 3%1 year growth
↑ 3%2 year growth
↑ 3%Lundbeck's Lu AH69593 gets FDA Fast Track designation for narcolepsy. Oral orexin-2 receptor agonist moves forward in Lundbeck's sleep-wake disorder pipeline. Lundbeck has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy. The designation is an important regulatory step for Lundbeck as the company continues to develop new treatment options for people living with sleep-wake disorders. Lu AH69593 was discovered by Lundbeck and is currently being studied in a Phase 1b clinical program for patients with narcolepsy. Lu AH69593 targets the orexin pathway. Lu AH69593 is being developed as a small-molecule agonist that activates the orexin 2 receptor, also known as OX2R. The idea behind the treatment is fairly straightforward. Orexin is a natural chemical messenger in the brain that plays an important role in keeping people awake and helping the brain maintain a stable sleep-wake cycle. Orexin works through two main receptors, called orexin 1 receptor and orexin 2 receptor. The OX2R is considered particularly important for the brain's wake-promoting system. Lu AH69593 is designed to activate this receptor and strengthen orexin signaling. Lundbeck is developing the compound with the goal of restoring wakefulness and improving sleep-wake regulation in people with narcolepsy. The company is aiming to develop Lu AH69593 as a potentially best-in-class treatment, although its safety and effectiveness have not yet been established. FDA Fast Track designation marks a regulatory milestone. The FDA's Fast Track program is intended to support the development and review of medicines that are being developed for serious conditions where there is an unmet medical need. For Lundbeck, the designation provides an opportunity to work more closely with the FDA as the development of LuAH69593 continues. Johan Luthman, executive vice president of R&D at Lundbeck, said the designation reflects the need for new treatment approaches for people living with narcolepsy and the company's interest in translating orexin biology into potential new therapies. The designation does not mean that Lu AH69593 has been approved or that the treatment has been proven to work. It is a regulatory development designation intended to help support the drug development process. Narcolepsy can disrupt everyday life. Narcolepsy is a chronic neurological disorder that affects the brain's ability to regulate sleep and wakefulness. For someone living with narcolepsy, staying awake during the day can become a major challenge. The condition can cause excessive daytime sleepiness and sudden sleep attacks, sometimes making it difficult to stay awake during work, school or other daily activities. People may also experience fragmented sleep at night, sleep paralysis, and hallucinations. In narcolepsy type 1, patients can also experience cataplexy. This causes a sudden loss of muscle tone and can sometimes be triggered by strong emotions. These symptoms can affect much more than sleep. They may interfere with education, employment, social activities and a person's overall quality of life. Orexin plays an important role in wakefulness. Orexin, also known as hypocretin, is a neuropeptide produced by specialized neurons in an area of the brain called the lateral hypothalamus. These neurons send signals to several areas of the brain involved in wakefulness, arousal and sleep regulation. The orexin system helps the brain stay awake and maintain a stable transition between sleeping and waking. In people with narcolepsy type 1, low levels of orexin or hypocretin are a key biological feature of the disease. This makes the orexin pathway an important area of research for developing new narcolepsy treatments. By activating the OX2R, Lu AH69593 is designed to work directly on a pathway that is closely connected to wakefulness. Current narcolepsy treatments still leave challenges Existing treatments can help people manage narcolepsy symptoms, but the condition continues to create a significant burden for many patients. Some people continue to experience excessive daytime sleepiness and other symptoms even while receiving treatment. This is one reason researchers are exploring new approaches that target the underlying biology of sleep and wakefulness rather than only managing symptoms. Lundbeck's approach with Lu AH69593 focuses on activating the orexin pathway to potentially improve wakefulness and sleep-wake stability. Lu AH69593 remains in Phase 1b development Lu AH69593 is currently being evaluated in a Phase 1b clinical program. At this stage, Lundbeck is assessing important factors such as the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics. The results from these studies will help determine how the medicine behaves in the body and how it affects the biological pathways it is designed to target. The company has not yet established the efficacy and safety of Lu AH69593. The compound is also not approved for marketing by any regulatory authority worldwide. Lundbeck continues to build its sleep-wake disorder pipeline The Fast Track designation comes as Lundbeck continues to expand its development programmes in brain health and sleep-wake disorders. The company is focusing on treatments that could address significant unmet needs in neurological conditions. For Lu AH69593, the focus is on using the biology of the orexin system to develop a new approach to treating narcolepsy. As the Phase 1b program progresses, future clinical development will determine whether the oral OX2R agonist can demonstrate meaningful benefits for people living with narcolepsy and potentially move into later-stage clinical trials.
Lundbeck secures FDA Fast Track for narcolepsy drug. Designation supports development of novel orexin therapy Lundbeck has received Fast Track designation from the U.S. FDA for Lu AH69593, its lead oral orexin 2 receptor agonist in development for narcolepsy. The compound, discovered by Lundbeck, is in phase 1b studies. Narcolepsy is a chronic neurological disorder that impairs the brain's regulation of sleep and wakefulness. Symptoms can include excessive daytime sleepiness, sudden sleep attacks, fragmented nighttime sleep, sleep paralysis and hallucinations. In narcolepsy type 1, cataplexy can also occur. These symptoms can affect daily functioning, education, work, social life and quality of life. Orexin is a wake-promoting neuropeptide central to stabilising sleep and wakefulness. Orexin-producing neurons project widely across the brain to regions involved in arousal, wakefulness and REM sleep regulation. Orexin signals through two receptors, of which the orexin 2 receptor is considered central to wake-promoting signalling and sleep-wake regulation. Disruption of orexin signalling is a relevant therapeutic target in narcolepsy and other disorders characterised by excessive daytime sleepiness. Lu AH69593 is designed to activate the orexin 2 receptor and enhance wake-promoting signalling through the orexin pathway. By targeting a pathway directly linked to wakefulness biology, the compound is intended to restore wakefulness and sleep-wake regulation in people living with narcolepsy, where current treatments can help manage symptoms but significant disease burden remains. Johan Luthman, Executive Vice President R&D, Lundbeck, said: "Fast Track designation is an important milestone for Lu AH69593 and for its ambition to translate compelling orexin biology into a new treatment approach for narcolepsy and other sleep-wake disorders. "For people living with narcolepsy, the ability to sustain wakefulness can shape almost every part of daily life. Fast Track designation underscores the urgent need for innovative therapies for narcolepsy and recognizes the potential of Lu AH69593." He added: "This program is a good example of Lundbeck's transformation of the R&D pipeline into breakthrough neurology, neuroendocrine and rare indication programs, with potential for regulatory designations facilitating development. We are encouraged by the opportunity to work closely with the FDA as we advance Lu AH69593." Fast Track designation is an FDA process intended to facilitate development and expedite review of medicines for serious conditions and unmet medical needs.
Tarek Samad takes on task of delivering on Lundbeck's R&D. Lundbeck has looked internally to fill the role of head of R&D following the retirement of Johan Luthman, elevating Tarek Samad from his current position as global head of research and corporate patents. There will be a handover period for a few months, with Luthman - who has held the top R&D job at Lundbeck for seven years - remaining at the company for the remainder of this year. Samad will officially take up the new role on 1st September. He will be responsible for delivering on Lundbeck's pipeline during a challenging period for the Danish pharma group, which is facing a hit to its revenues in the coming years as it loses patent protection for antidepressant Trintellix/Brintellix (vortioxetine) and current growth driver Rexulti (brexpiprazole), used to treat depression, schizophrenia, and agitation associated with Alzheimer's dementia. Those two drugs alone accounted for around 43% of Lundbeck's total revenues last year, and the company has already embarked on a major restructuring drive, handing over its operations in 27 markets to partner companies Swixx Group, Zuellig Pharma, and NewBridge Pharmaceuticals - a move that has allowed it to take more than 600 jobs off its payroll. In a statement, Lundbeck said that the appointment of Samad reflects its commitment to leadership continuity, noting that since 2021, he has played "an instrumental role in executing Lundbeck's R&D strategy, advancing its innovation capabilities, and strengthening its research collaborations." The new R&D chief will oversee the development of four programmes identified by Lundbeck as being the key to its growth prospects. Those include anti-adrenocorticotropic hormone (ACTH) candidate asedebart (formerly Lu AG13909), which earlier this month saw positive mid-stage results in patients with Cushing's disease. The others are anti-alpha-synuclein antibody amlenetug for multiple system atrophy (MSA) - it's worth noting that midstage data for that was a bit mixed - as well as anti-PACAP drug bocunebart for migraine prevention and 5-HT 2C receptor super-agonist bexicaserin for seizures associated with rare forms of epilepsy. Lundbeck acquired the latter when it bought Longboard Pharma last year for $2.6 billion. "Lundbeck combines a unique legacy of scientific excellence with an unwavering commitment to advancing innovation and improving the lives of people living with brain diseases," said Samad of his new role. "Over the past five years, I have had the privilege of working alongside Johan and the broader R&D organisation to advance our science, strengthen our capabilities, and accelerate the progress of our pipeline," he added. "I look forward to building on this strong foundation." 25 June, 2026
Tarek Samad appointed EVP, Head of Research & Development at Lundbeck. Valby, Denmark, 24 June, 2026 - H. Lundbeck A/S (Lundbeck) today 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. A transition period will commence in July 2026 to ensure a seamless handover of responsibilities, and Johan Luthman will remain with Lundbeck until the end of 2026 to ensure continuity across key strategic and scientific priorities. "I would like to thank Johan Luthman for his outstanding contributions to Lundbeck. Under his leadership, our R&D organization has undergone a major restructuring and shift in scientific focus and capabilities. Johan has played a key role in establishing a transformed, innovative pipeline while bringing important new products to the market in line with our Focused Innovator strategy," said CEO Charl van Zyl. "At the same time, I am pleased to welcome Tarek Samad to the ELT. Through his leadership of our Research organization, I have seen firsthand his ability to advance scientific excellence, build high-performing teams, and leverage strategic partnerships and emerging technologies to strengthen our innovation engine. Tarek has been a key contributor to the development and execution of our R&D strategy and to the progress we have achieved across our pipeline. As we continue to build on the momentum, I am confident that Tarek Samad is the right leader to guide our R&D organization through its next phase of innovation and growth, delivering meaningful advances for patients." Tarek Samad currently serves as Senior Vice President, Global Head of Research and Corporate Patents at Lundbeck, where he has led the company's global research organization since 2021 and played an instrumental role in executing Lundbeck's R&D strategy, advancing its innovation capabilities and strengthening its research collaborations. His appointment reflects Lundbeck's strong internal talent pipeline and commitment to leadership continuity. Prior to joining Lundbeck, Tarek Samad held senior research leadership positions at Immunitas Therapeutics, Sanofi and Pfizer, and previously served on the faculty of Harvard Medical School and Massachusetts General Hospital. "I am excited to take on the role of EVP and Head of Research & Development and to join Lundbeck's Executive Leadership Team," said Tarek Samad. "Lundbeck combines a unique legacy of scientific excellence with an unwavering commitment to advancing innovation and improving the lives of people living with brain diseases. Over the past five years, I have had the privilege of working alongside Johan and the broader R&D organization to advance our science, strengthen our capabilities, and accelerate the progress of our pipeline. I look forward to building on this strong foundation and working with colleagues across Lundbeck and our external partners to deliver transformative treatments for patients." Tarek Samad succeeds Johan Luthman, who has led Lundbeck's R&D organization since 2019. Under his leadership, Lundbeck's scientific competence and expertise have been substantially transformed. While establishing broader drug modality platforms and transitioning into new biological research areas, the company has built a richer, innovative pipeline, dominated by first-in-class opportunities across development stages. During Johan's tenure, R&D has delivered successful new products and lifecycle management across global markets, reinforcing Lundbeck's leadership in neuroscience. "After seven exciting years at Lundbeck, I believe this is the right time to transition the leadership of the R&D organization," said Johan Luthman. "Through dedicated efforts and passion for science and patients, we have fundamentally changed the trajectory of Lundbeck. Our major transformation over several years has significantly expanded our innovation potential and positioned us to be truly premier in neuroscience R&D. We have brought innovative new medicines to patients, provided strong support for our products, and built a promising future for Lundbeck. I am proud of what we have achieved and immensely grateful to all the talented colleagues who have made this progress possible, and I am delighted to see Tarek Samad appointed as my successor." Contacts. | Jens Høyer | Anders Crillesen | | Vice President, Head of Investor Relations | Senior Director, External & Internal Relations | | [email protected] | [email protected] | | +45 30 83 45 01 | +45 29 79 12 86 | | / | / | About H. Lundbeck A/S. Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, Transparency International is 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, Transparency International hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, Transparency International strive for its research and development programs to tackle some of the most complex neurological challenges. Transparency International develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from its strong legacy within psychiatry and neurology. Transparency International is committed to fighting stigma and Transparency International act to improve health equity. Transparency International strive to create long term value for its 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 its products are available in more than 80 countries. For additional information, Transparency International encourage you to visit its corporate site www.lundbeck.com and connect with Transparency International via LinkedIn. Safe Harbor/Forward-Looking Statements This corporate release contains forward-looking statements that provide its expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Forward looking statements include, without limitation, any statement that may predict, forecast, indicate or imply future results, performance or achievements, and may contain words like "believe", "anticipate", "expect", "estimate", "intend", "plan", "project", "will be", "will continue", "will result", "could", "may", "might", or any variations of such words or other words with similar meanings. All statements other than statements of historical facts included in this corporate release, including, without limitation, those regarding its financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to its products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause its actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Factors that may affect future results include, among others, interest rate and currency exchange rate fluctuations, delay or failure of development projects, production or distribution problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. The forward-looking statements in this document and in oral presentations made on behalf of Lundbeck speak only as at the date of this document. Lundbeck does not undertake any obligation to update or revise forward-looking statements in this corporate release or oral presentations made on behalf of Lundbeck, nor to confirm such statements to reflect subsequent events or circumstances after the date of the release, presentation or in relation to actual results, unless otherwise required by applicable law or applicable stock exchange regulations. H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 [email protected]
HMNC Brain Health appoints former Lundbeck exec as CMO. 17 June 2026 German neuroscience company HMNC Brain Health has appointed former Lundbeck (CPH: HLUN-B) executive Bjørn Grønning (pictured above) as chief medical officer as it prepares two depression programs for Phase III-readiness activities. Dr Grønning succeeds Hans Eriksson following a planned transition and will lead HMNC's global clinical development strategy across its neuroscience pipeline. This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here. Try before you buy Free. 7 day trial access * All the news that moves the needle in pharma and biotech * Exclusive features, podcasts, interviews, data analyses and commentary from its global network of life sciences reporters. * Receive The Pharma Letter daily news bulletin, free forever. Become a subscriber £820. Or £77 per month * Unfettered access to industry-leading news, commentary and analysis in pharma and biotech. * Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results. * Daily roundup of key events in pharma and biotech. * Monthly in-depth briefings on Boardroom appointments and M&A news. * Choose from a cost-effective annual package or a flexible monthly subscription The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It's part of the key information for keeping me informed Chairman, Sanofi Aventis UK More on this story... 16 June 2026 3 June 2026 10 June 2026 Company news directory. Companies featured in this story. Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news Today's issue. 17 June 2026 Company spotlight. An ASX-listed Australian clinical-stage biotechnology company advancing DMX-200 (proposed brand name Qytovra), a CCR2 inhibitor in Phase III development for focal segmental glomerulosclerosis, with five global licensing deals now generating over A$65 million in revenue. More features in biotechnology. 17 June 2026
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About Lundbeck
Industries
Biotechnology
Healthcare
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Copenhagen, Denmark
Founded
1915
There are no jobs for Lundbeck right now.
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