UCB Kygevvi receives positive CHMP opinion in ultra-rare disease TK2d
Friday during trading hours, UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of marketing authorisation under exceptional circumstances for Kygevvi (doxecitine and doxribtimine) for the treatment of pediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years. Following the positive CHMP opinion, the EC decision is expected in 2Q26, and we note that the EC usually follows the CHMP recommendation. Beyond the EU, the product received FDA approval in the US in 4Q25 and the company previously communicated that it expects Kygevvi to be commercially available in the US in 1Q26. € 270 TP and Accumulate maintained.UCB is a global biopharmaceutical company focused on severe diseases in two therapeutic areas, namely central nervous system disorders and immunology. In the area of central nervous system disorders, Co. is focused on advanced Parkinson's disease, epilepsy, restless legs syndrome and epilepsy. In the area of immunology disorders, Co. is focused on rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, post-menopausal osteoporosis, systemic lupus erythematosus and immunological diseases.
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