Lundbeck

Valby – October 02, 2026 -- H. Lundbeck A/S will present late-breaking Phase III data on its multiple system atrophy (MSA) drug candidate amlenetug alongside new Parkinson's disease pipeline results at the International Congress of Parkinson's Disease and Movement Disorders (MDS) 2026 in Seoul, South Korea, running October 4-8.

MASCOT trial enrolled 401 participants across a global Phase III program

The late-breaking oral presentation will detail baseline characteristics of participants in MASCOT (NCT06706622), Lundbeck's ongoing Phase III trial of amlenetug in MSA. The trial enrolled 401 participants with clinically probable or established MSA, covering both MSA-C and MSA-P subtypes, across sites in North America, Europe, Asia and Australia. The double-blind treatment period runs 72 weeks, comparing high- and low-dose amlenetug against placebo, with results expected in Q3 2027.

Valby, Denmark – – September 16, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing's syndrome.

FDA designation adds U.S. market exclusivity potential for Lundbeck's rare disease pipeline

The designation covers drugs and biologics intended for rare diseases and can provide tax credits for qualified clinical testing, exemption from certain FDA application fees, and up to seven years of market exclusivity if the drug is approved for the designated indication.

Valby, Denmark – September 07, 2026 -- Lundbeck will present preclinical data at the European Epilepsy Congress in Athens showing its investigational drug bexicaserin simultaneously increases inhibitory and decreases excitatory neuronal activity in hippocampal brain tissue, a dual mechanism the company says supports broad-spectrum antiseizure potential across multiple epilepsy types.

Preclinical study links dual mode of action to broader seizure control