Lundbeck receives marketing authorization for Vyepti® (eptinezumab) in South Korea for the preventive treatment of migraine
* Approval granted by South Korea's Ministry of Food and Drug Safety (MFDS) * Eptinezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the preventive treatment of migraine in adults * Authorization supported by the Phase 3 SUNRISE trial conducted in a predominant...
Lundbeck receives orphan drug designation in Japan for asedebart for the treatment of patients with congenital adrenal hyperplasia and Cushing's disease
* Congenital adrenal hyperplasia (CAH) and Cushing's disease (CD) are rare disorders characterized by excess adrenocorticotropic hormone (ACTH) produced in the brain1,2 * Current treatments are limited by suboptimal disease control and treatment-related complications3,4 * Asedebart (Lu AG13...
Lundbeck presents new data at AAN 2026 highlighting real-world changes in migraine-related cognitive symptoms after starting VYEPTI® (eptinezumab)
• The one-year INFUSE study observed patient-reported migraine-related cognitive symptoms at baseline and changes over 6 months in those with at least one prior anti-calcitonin gene-related peptide (anti-CGRP) treatment failure VALBY, Denmark, April 20, 2026 /PRNewswire/ -- H. Lundbeck A/S (Lund...
Lundbeck files for marketing authorization across key Asian markets for Vyepti® (eptinezumab) for the preventive treatment of migraine
* Lundbeck's new drug application (NDA) for Vyepti® (eptinezumab) accepted by Japan's Ministry of Health, Labor and Welfare (MHLW), marking a significant step forward towards expanding access to the novel preventive migraine treatment for patients acrossJapan * Similar marketing authorization...
Lundbeck delivers 14% CER revenue growth, reflecting stronger momentum from Vyepti® and Rexulti® driven by additional investments
VALBY, Denmark, Nov. 12, 2025 /PRNewswire/ -- Key highlights Lundbeck's total revenue grew by +14% CER[1] (+13% DKK) to DKK 18,537 million in the first nine months of 2025. Growth in the U.S. andEurope was the driver of this strong performance. * United States: DKK 9,955 million (+22% CER; +19...
Lundbeck's bexicaserin receives Breakthrough Therapy Designation in China for the treatment of seizures in severe rare epilepsies
* Accelerated pathway underscores urgent need for innovative solutions for patients with devastating, childhood-onset epilepsies * Novel 5HT2C mechanism designed to reduce drug-resistant seizures in children and adults living with Developmental Epileptic Encephalopathies (DEEs) and improve qu...
Lundbeck to showcase amlenetug Phase 3 MASCOT trial design in Multiple System Atrophy at the International Congress of Parkinson's Disease and Movement Disorders® 2025
* Details of the Phase 3 MASCOT trial investigating amlenetug for the treatment of patients with Multiple System Atrophy (MSA) will be presented at the International Congress of Parkinson's Disease and Movement Disorders® 2025 1-3 * MSA is a rare, rapidly progressing, neurodegenerative disease...
Lundbeck showcases new clinical migraine data, including long-term preventive effectiveness of Vyepti® (eptinezumab) in patients severely impacted by migraine
* Lundbeck demonstrates leadership and unwavering commitment to advancing migraine management and supporting patient outcomes with six presentations at the 2025 International Headache Congress (IHC), including three oral presentations on eptinezumab (Vypeti®) and Lu AG09222 (anti-PACAP mAb) *...
Lundbeck to present new data on bexicaserin at upcoming congress, highlighting long-term impact on seizure frequency in patients with rare epilepsy
* The full results of the open label extension (OLE) of the Phase 1b/2a PACIFIC trial investigating bexicaserin for the treatment of patients with Developmental and Epileptic Encephalopathies (DEEs), will be presented for the first time at the International Epilepsy Annual Congress1 * DEEs ar...
Lundbeck's potential treatment for Multiple System Atrophy granted Orphan Drug Designation in Japan
VALBY, Denmark, March 10, 2025 /PRNewswire/ -- The Ministry of Health, Labor, and Welfare (MHLW) inJapan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). H. Lundbeck A/S (Lundbeck) a...
