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Lundbeck announces FDA plans to host an Advisory Committee meeting on the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD

H. Lundbeck A/S (Lundbeck) announces that the U.S. Food and Drug Administration (FDA) plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to seek input on issues related to the Supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The FDA’s decision to host a PDAC meeting does not reflect a final decision on the approvability. A final date for the meeting has yet to be set by the FDA, but it is currently anticipated to occur during the first half of 2025.

Lundbeck highlights commitment to the rare epilepsy community at American Epilepsy Society (AES) Annual Meeting with data presentations

Longboard Pharmaceuticals, now a wholly owned subsidiary of Lundbeck, presents scientific data in multiple poster presentations showcasing the potential of bexicaserin in Developmental and Epileptic Encephalopathies (DEEs) at the American Epilepsy Society (AES) Annual Meeting in Los Angeles, U.S.H. Lundbeck A/S (Lundbeck) today announced that data will be presented for bexicaserin, a novel, highly selective investigational potential treatment in development for seizures associated with Developmental and Epileptic Encephalopathies (DEEs), in poster sessions at the 2024 AES Annual Meeting.

Lundbeck completes acquisition of Longboard

· A significant step forward in Lundbeck’s Focused Innovator strategy and advancing the goal of building a robust neuro-rare franchise · The lead asset, bexicaserin, holds blockbuster potential and is in development for the treatment of DEEs in a program enrolling patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and other DEE syndromes · Bexicaserin has shown encouraging anti-seizure effects to date in preclinical and clinical studies, with its next-generation superagonist mechanism specifically targeting 5-HT2C receptors, supporting bexicaserin’s potential to offer a

Lundbeck announces expiration of Longboard tender offer and that all tender offer conditions are fulfilled

· A significant step forward in Lundbeck’s Focused Innovator strategy and advancing the goal of building a robust neuro-rare franchise · The transaction is expected to close on December 2, 2024, following Lundbeck’s acceptance of all shares of common stock validly tendered and not validly withdrawn pursuant to the tender offer · Total transaction value of approximately USD 2.6 billion equity value and USD 2.5 billion net of cash (approximately DKK 17 billion) · The acquisition is expected to contribute to Lundbeck’s long-term revenue growth potential following expected launch in

Lundbeck initiates a phase III trial with amlenetug for the treatment of Multiple System Atrophy

MASCOT, a global phase III randomized, double-blind, placebo-controlled trial, will assess the efficacy and safety of amlenetug in the treatment of Multiple System Atrophy (MSA)H. Lundbeck A/S (Lundbeck) today announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial. The trial builds on the encouraging results of the AMULET phase II trial showing consistent trend towards amlenetug slowing clinical progression in MSA patients despite the primary endpoint not meeting

Accelerated growth for strategic brands (+21% CER) drives revenue up 13% CER in the first nine months of 2024

Accelerated growth for strategic brands (+21% CER) drives revenue up 13% CER in the first nine months of 2024 Key highlights Lundbeck’s total revenue grew by +13% CER[1] (+10% DKK) to DKK 16,463 million in the first nine months of 2024, with all regions contributing to growth · United States: DKK 8,342 million (+14% CER; +14% DKK) · Europe: DKK 3,815 million (+12% CER; +10% DKK) · International Operations: DKK 4,062 million (+9% CER; +3% DKK) The revenue of Lundbeck’s strategic brands increased by +21% CER (+20% DKK), reaching DKK 12,116 million, representing 74% of

Lundbeck announces positive results from phase III pivotal trial (SUNRISE) of Vyepti® (eptinezumab) in migraine prevention

· Vyepti® confirms efficacy in new phase III pivotal SUNRISE trial, meeting primary endpoint with statistically significant reductions in mean monthly migraine days compared with placebo · Vyepti® met all key secondary efficacy endpoints in the SUNRISE trial, and the treatment was generally well tolerated · Beginning day 1 after infusion, Vyepti® lead to statistically significant reductions in the risk of experiencing migraine compared to placebo H. Lundbeck A/S (Lundbeck) announced that Vyepti® (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III

Capital Markets Event 2024: Lundbeck to showcase progress on Focused Innovator Strategy driving sustainable long-term growth

· Execution of the Focused Innovator strategy is well under way with key elements delivering good progress and laying foundation for long-term sustainable growth · Mid-term targets are adjusted by including 2027. Revenue is expected to grow mid-single digit (CAGR) driven by high-single digit growth of strategic brands · Adjusted EBITDA margin is revised from 30% - 32% to now more than 30% at the end of the mid-term period, to account for the cost impact from Longboard Pharmaceuticals* · Building upon our psychiatry core, reinforcing our neuro-specialty position and strengthening

Lundbeck to acquire Longboard Pharmaceuticals in a strategic deal, significantly enhancing its neuroscience pipeline

· The proposed acquisition represents a significant step forward in Lundbeck’s Focused Innovator strategy, adding a highly innovative and complementary product in late-stage development for Developmental and Epileptic Encephalopathies (DEEs) - an area of high unmet medical need · The acquisition will enhance and complement Lundbeck’s capabilities and presence within neuro-rare conditions · The lead asset, bexicaserin, holds blockbuster potential and is in development for the treatment of DEEs in a program enrolling patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and

Lundbeck initiates clinical trial in immunology for Lu AG22515 in Thyroid Eye Disease

H. Lundbeck A/S (Lundbeck) today announced taking one further step in developing treatments for indications in the neuroimmunology and neuroinflammatory space with the initiation of the first clinical trial of its CD40L blocker, Lu AG22515, in patients.Lundbeck’s proof-of-concept (PoC) trial will evaluate the efficacy, safety, and tolerability of Lu AG22515 as a potential treatment for Thyroid Eye Disease, an autoimmune disease causing a debilitating, disfiguring, and potentially blinding periocular condition. “We are excited to initiate our first project within neuroimmunology with this

Lundbeck presents results from two studies in Multiple System Atrophy at International Congress of Parkinson's Disease and Movement Disorders

Lundbeck advances its commitment to addressing the unmet needs of Multiple System Atrophy (MSA) with the TALISMAN study, adding to the encouraging results from the AMULET trial.H. Lundbeck A/S (Lundbeck) announces data from the TALISMAN natural history study, as well as additional data from the AMULET trial of amlenetug (Lu AF82422) in Multiple System Atrophy (MSA) at the International Congress of Parkinson's Disease and Movement disorders (MDS congress) in Philadelphia, USA. The TALISMAN study is a step forward in Lundbeck’s commitment to understanding the course of MSA and developing

Lundbeck and Iambic Therapeutics announce strategic partnership to leverage AI for drug discovery

Lundbeck partners with Iambic to utilize its AI-powered drug discovery platform to accelerate research and therapeutic innovation for neurological diseaseVALBY, DENMARK and SAN DIEGO, CA, – H. Lundbeck A/S (Lundbeck), an innovator within CNS disorders and Iambic Therapeutics, a clinical-stage biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, today announced the companies have entered into a strategic research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine. The agreement includes an upfront

Lundbeck raised financial guidance following strong growth (+19% CER) from strategic brands, on path towards becoming a Focused Innovator

Key highlights Lundbeck’s total revenue grew by +10% CER[1] (+8% DKK) to DKK 10,741 million in the first six months of 2024, with all regions contributing to growth · United States: DKK 5,307 million (+11% CER; +11% DKK) · Europe: DKK 2,517 million (+10% CER; +8% DKK) · International Markets: DKK 2,795 million (+8% CER; +2% DKK) The revenue of Lundbeck’s strategic brands increased by +19% CER (+18% DKK), reaching DKK 7,799 million, representing 73% of total revenue · Rexulti®: DKK 2,381 million (+13% CER; +12% DKK) · Brintellix®/Trintellix®: DKK 2,351 million (+11%

Lundbeck raises financial guidance for 2024

Valby, Denmark, August 20, 2024 - H. Lundbeck A/S (Lundbeck) announced revenue and adjusted EBITDA growth at constant exchange rates (CER) for the first six months of 2024 and that the full year revenue and adjusted EBITDA outlook at CER have been raised. In the second quarter of 2024, Lundbeck’s revenue increased by 13% and adjusted EBITDA increased by 14% both at CER. Key figures Growth (CER) H1 2024 Q2 2024Revenue 10% 13%EBITDA 9% 17%Adjusted EBITDA 5% 14% The sales outlook for 2024 is updated, primarily reflecting

Lundbeck and Otsuka announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD)

· The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA · The FDA target date (PDUFA date) for completion of the review is 8 February 2025 · If approved, brexpiprazole and sertraline combination treatment would be the first FDA-approved pharmacological treatment for PTSD in more than 20 years  Valby, Denmark, 25 June 2024 – H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce the U.S. Food and Drug

Lundbeck broadens focus on neurohormonal dysfunctions with new Cushing’s disease trial

Lundbeck is exploring a new area in neurohormonal dysfunctions by initiating a phase II trial using Lu AG13909 as a potential treatment for Cushing’s disease. This marks an important step in Lundbeck’s commitment to advancing promising scientific innovations.H. Lundbeck A/S (Lundbeck) is enhancing its research and development in neurohormonal dysfunctions. A key part of this strategy is the development of Lu AG13909, a first-in-class monoclonal antibody (mAb) that targets the adrenocorticotropic hormone (ACTH). By binding to ACTH with high affinity, Lu AG13909 aims to reduce elevated

Lundbeck presents innovative first in human trial design of Lu AG13909 for potential treatment of congenital adrenal hyperplasia

Lundbeck is to showcase innovative trial design at ENDO 2024 of the first in human trial of Lu AG13909 for congenital adrenal hyperplasia (CAH), a rare debilitating disease with excess morbidity and mortality.H. Lundbeck A/S (Lundbeck) will present the novel design of the first in human trial of Lu AG13909, a potential first-in-class treatment for CAH, at ENDO in Boston. The presentation will take place on 3 June 2024, at 12:00 (noon) EDT. The poster is to be presented by trial investigator Dr. Srirangalingam Umasuthan, University College London Hospitals, London, UK, who said: “We

Lundbeck grows strategic brands by +17% CER reaching total revenue of DKK 5.3 billion in the first quarter of 2024

Key highlights Lundbeck’s revenue increased by 7% CER[1] (+5% DKK) to DKK 5,288 million in the first quarter of 2024, mainly driven by growth in the U.S. and Europe · United States: DKK 2,498 million (+9% CER; +7% DKK) · Europe: DKK 1,248 million (+9% CER; +6% DKK) · International Markets: DKK 1,481 million (+4% CER; -1% DKK) The revenue of Lundbeck’s strategic brands increased by 17% CER (+15% DKK), reaching DKK 3,759 million, representing 71% of total revenue · Brintellix[®]/Trintellix[®]: DKK 1,168 million (+11% CER; +8% DKK) · Rexulti[®]: DKK 1,115 million (+7%

Maria Alfaiate appointed new Executive Vice President Commercial and Corporate Strategy at Lundbeck

H. Lundbeck A/S (Lundbeck) today announced the appointment of Maria Alfaiate to the newly established role of EVP, Commercial and Corporate Strategy. Maria will join Lundbeck on 1 August 2024 and will be part of the Executive Management team.Maria Alfaiate will be responsible for strengthening corporate strategic functions and enhancing global marketing efforts. Her focus will be on optimizing Lundbeck’s ability to capitalize on both present and future opportunities. Maria brings significant experience from the life science and pharmaceutical sectors globally. Her expertise in developing

Lundbeck held its Annual General Meeting on 20 March 2024 at the company’s registered office

Valby, Denmark, 20 March 2024 - H. Lundbeck A/S (Lundbeck) announced today that the report by the Board of Directors was adopted and the annual report was approved at the annual general meeting.  The Annual Report 2023 was adopted. The proposal to distribute a dividend of 30% of the net profit for the accounting year 2023, corresponding to DKK 0.70 per share, or a total dividend of DKK 697 million, was adopted. The Remuneration Report for 2023 was approved in the advisory vote. Lars Søren Rasmussen, Lene Skole-Sørensen, Lars Erik Holmqvist, Jeffrey Berkowitz, Santiago Arroyo,

Lundbeck’s potential first-in-class therapy for migraine prevention enters advanced clinical stage

PROCEED, a clinical phase IIb dose-finding trial will assess the efficacy and safety of subcutaneously administered Lu AG09222 in migraine prevention.H. Lundbeck A/S (Lundbeck) announced the advancement of the clinical development of Lu AG09222 for migraine prevention with the initiation of PROCEED, a randomized, double-blind, phase IIb, dose-finding trial to assess efficacy and safety of multiple subcutaneously administered doses. The PROCEED trial builds on the positive results of the HOPE phase IIa Proof-of-Concept trial demonstrating efficacy of intravenously administered Lu AG09222

Lundbeck presents encouraging results from the Lu AF82422 trial for Multiple System Atrophy at the international AD/PD 2024 conference on neurodegenerative disorders

The AMULET trial strengthens the case for Lundbeck's Lu AF82422, as initial clinical data suggests that the anti-alpha-synuclein monoclonal antibody (mAb) has a potential to slow clinical progression.H. Lundbeck A/S (Lundbeck) announces clinical data from the AMULET phase II, double-blind, randomized trial of Lu AF82422 in Multiple System Atrophy (MSA) at the International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD 2024) on March 8, 2024, in Lisbon, Portugal. The presentation will start at 4:35 PM CET. Lu AF82422 is a human monoclonal

Notice of Annual General Meeting

Valby, Denmark, 23 February 2024 - Notice is hereby given of the annual general meeting of H. Lundbeck A/S to be held on:  Wednesday, 20 March 2024 at 10:00 am CET   The annual general meeting will be held at the offices of the Company at:  H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby  Agenda  In accordance with Article 8.1 of the Articles of Association, the agenda of the meeting is as follows:  1. Report of the Board of Directors on the Company’s activities during the past year. 2. Presentation and adoption of the annual report. 3. Resolution on the appropriation of

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