UCB: Two Studies Confirm the Efficacy of Kygevvi in TK2d
UCB: Two studies confirm the efficacy of Kygevvi in TK2d. The results document improvements in survival and function in treated patients, as well as the progressive burden of the disease in the absence of treatment.
Kygevvi Improves Survival and Function in Patients with TK2d
The first published study involves an integrated analysis of the safety and efficacy of Kygevvi (doxecitine and doxribtimine) in 104 treated patients and 114 untreated patients. The data indicates that the treatment has improved survival and functional outcomes in patients with genetically confirmed TK2d, with acceptable tolerance. Kygevvi, approved by the FDA in November 2025 and by the EMA in March 2026 under an exceptional procedure, remains the first and only authorized treatment for this indication in pediatric and adult patients with TK2d and symptom onset at age 12 or younger.
Untreated Disease Leads to Severe Progression and Early Mortality
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The second study reveals data from the largest published cohort of untreated TK2d patients, consisting of 257 individuals. This analysis highlights the progressive burden of the disease and the increased risk of early death in the absence of treatment. Untreated TK2d has serious impacts on daily life and life expectancy, particularly in patients whose symptoms appear at an early stage, underlining the urgent need for genetic diagnosis and access to treatments for this ultra-rare disease.
SectorPharmacie et biotechnologies›Vaccins et laboratoires de recherche
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Context
Period
Period: S1 2026
Key reported figures
Revenue: 4 270 millions d'euros
Quarterly revenue: 4 270 millions d'euros
Revenue growth: 22,5 %
EBITDA: 1 685 millions d'euros
EBITDA margin: 40,7 %
Net income: 1 111 millions d'euros
2 821 millions d'euros
Guidance from the release
Based on the continued strong growth, revenue is expected to grow in the low-teens to mid-teens percentage range; Reflecting our strong execution and confidence in the outlook
Risks mentioned
Perte d'exclusivité de BRIVIACT aux États-Unis depuis février 2026 et en Europe attendue en août 2026
Ventes de VIMPAT au Japon affectées par l'arrivée de génériques fin 2025
Expiration en 2026 de la protection brevetaire de CIMZIA au Japon
Opportunities identified
Objectif de ventes maximales de BIMZELX relevé à au moins 7 milliards d'euros
Supériorité de BIMZELX sur risankizumab dans le rhumatisme psoriasique (étude BE BOLD)
FINTEPLA déposé dans le syndrome CDKL5 auprès de la FDA et de l'EMA, Phase 3 lancée dans le syndrome de Rett
Outlook / guidance
Management commentary: revenue is expected to grow in the low-teens to mid-teens percentage range at constant exchange rates (CER). Adjusted EBITDA² is expected to grow in the mid-teens to low-twenties percentage range at CER. Excluding other operating one-offs in 2025, adjusted EBITDA² growth is expected to be in the mid-twenties to low-thirties percentage range at CER.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
