Report
David Seynnaeve, PhD

UCB - The waiting game continues

Last night, UCB provided a regulatory update on bimekizumab's BLA, most notably announcing they do not longer anticipate FDA action in Q3. No new guidance provided.Although unfortunate, not entirely unexpected considering that the FDA never confirmed this timing. On a positive note, the manufacturing facility inspection has been successfully finished, indicating that the main reason for 2022's CRL has been solved now.We do maintain our believe in ultimate approval of bime in the US but remain in the dark about precise timing thereof. We stick to our Buy rating on the name but expect a negative market reaction today. Next
Underlying
UCB S.A.

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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Degroof Petercam
Degroof Petercam

​We are an investment house with Belgian roots founded on more than 150 years of trust.

As a private company owned by long-term committed shareholders, we are independent. Naturally and structurally. Our experts have the knowledge to think and act without bias, and to make decisions that benefit our clients. Today and tomorrow.

Analysts
David Seynnaeve, PhD

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