LUNDBECK B Aktie

 

Valby, Denmark, 18 July 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck LLC (Lundbeck) announce that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of Rexulti® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment...

Otsuka Pharmaceutical Co.'s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers' bid to bring the first new drug for the condition to market in more than two decades....

Congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disease1 with an estimated global incidence of approximately 1 in 14,000–18,000 live births2 A phase II trial has recently been initiated to investigate the efficacy and safety of LuAG13909 for the potential treatment of......

Valby, Denmark, 22 May 2025 - H. Lundbeck A/S (Lundbeck) has successfully placed an aggregate principal amount of EUR 500 million senior unsecured notes with a tenor of four (4) years maturing 2 June 2029 (the "Notes") under its EUR 2 billion Euro Medium Term Note Programme (the “Programme”). The notes will be issued on 2 June 2025. The net proceeds from the issuance will be used to repay an existing bridge facility established as a short-term financing tool in connection with Lundbeck's acquisition of Longboard Pharmaceuticals Inc. As such, the issuance is leverage-neutral. The Notes...

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Key highlights Lundbeck's total revenue grew by +16% CER[1] (+18% DKK) to DKK 6,235 million in the first quarter of 2025, with all regions contributing to growth · United States: DKK 3,284 million (+25% CER; +31% DKK) · Europe: DKK 1,444 million (+16% CER; +16% DKK) · International Operations: DKK 1,528 million (+4% CER; +3% DKK) The revenue of Lundbeck's strategic brands increased by +24% CER (+28% DKK), reaching DKK 4,801 million, representing 77% of total revenue · Rexulti[®]: DKK 1,491 million (+28% CER; +34% DKK) · Brintellix[®]/Trintellix[®]: DKK 1,254 million...

VALBY, Denmark, May 8, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present key pipeline data and patient perspectives from the phase II AMULET trial, investigating amlenetug as a potential new treatment option targeting the rare neurological disorder, multiple system atrophy......

VALBY, Denmark, May 6, 2025 /PRNewswire/ -- H. Lundbeck A/S is pleased to announce its agreement with the Danish Centre for AI Innovation (DCAI), the company established to run and operate Gefion, Denmark's flagship AI supercomputer. Lundbeck is one of the first pharmaceutical companies......

VALBY, Denmark, April 4, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present positive interim results from the open-label extension of the PACIFIC trial investigating bexicaserin, in addition to new analyses from clinical trials and real-world data with eptinezumab. H. Lundbeck......

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PROCEED is an adaptive Phase IIb trial with Lu AG09222, an investigational mAb intended to block signaling by pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide that is believed to contribute to migraine. The PROCEED trial is designed to explore different doses and......

VALBY, Denmark, March 26, 2025 /PRNewswire/ -- 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 proposal to distribute a dividend of 30% of the net profit for the......

· Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older[1] · Approval follows a positive Committee for Medicinal Products for Human Use (CHMP) opinion from the European Medicines Agency in January 2025[2] · Treatment with brexpiprazole (2-4 mg/day) significantly reduced the symptoms of schizophrenia as measured by PANSS total score compared to placebo[3] Windsor, United Kingdom/Valby, Denmark, 13 March 2025 – Otsuka Pharmaceutical Europe Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the...

VALBY, Denmark, March 10, 2025 /PRNewswire/ -- The Ministry of Health, Labor, and Welfare (MHLW) in Japan 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......

Notice of Annual General Meeting Notice is hereby given of the annual general meeting of H. Lundbeck A/S to be held on: Wednesday, 26 March 2025 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...

Bexicaserin achieved an overall median seizure reduction of 59.3 percent in countable motor seizures over a 12-month open-label extension (OLE) treatment period. The treatment with bexicaserin demonstrated favorable safety and tolerability, with majority of participants completing the......

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....

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....

New results from the RESOLUTION trial demonstrate the efficacy of Vyepti® (eptinezumab) on top of patient education for patients severely impacted by migraine, with the placebo-controlled Phase IV trial finding that patients with chronic migraine and medication-overuse headache rapidly benefit from treatment with Vyepti. H. Lundbeck A/S (Lundbeck) today announced positive results from the RESOLUTION trial. This trial randomized 608 patients with a dual diagnosis of chronic migraine (CM) and medication-overuse headache (MOH) to receive an infusion of either Vyepti 100 mg or placebo. The...

· 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...