Ucb S A Stock Price, News & Analysis

UCB announced results from two Phase 3 studies, BE OPTIMAL and BE COMPLETE, evaluating bimekizumab for adults with active psoriatic arthritis. Both studies surpassed their primary endpoints with significant improvements at week 16: 43.9% of biologic-naïve patients and 43.4% of TNF-inadequate responders achieved ACR50 compared to 10.0% and 6.8% on placebo (p<0.001). Additionally, over 60% of bimekizumab-treated patients reached PASI90. The results will be presented at EULAR 2022 but safety and efficacy aren't established for regulatory approval.

UCB announced significant results from two Phase 3 studies of investigational treatments for generalized myasthenia gravis: zilucoplan and rozanolixizumab. Both showed statistically significant improvements in gMG-specific outcomes, with regulatory submissions expected later this year. The RAISE study found zilucoplan improved the Myasthenia Gravis Activities of Daily Living score by 2.12 points versus placebo (p<0.001). Similarly, the MycarinG study showed rozanolixizumab reduced symptoms significantly, with reductions in IgG levels. Both treatments were generally well-tolerated.

UCB announced the publication of a Phase 3 trial in JAMA Neurology, demonstrating that FINTEPLA (fenfluramine) significantly reduces drop seizure frequency in Lennox-Gastaut Syndrome (LGS) patients. The study met its primary endpoint, with a mean reduction of 19.9% in drop seizures compared to placebo (P=.001). FINTEPLA, recently approved by the FDA, is shown to be effective in patients suffering from generalized tonic-clonic seizures, addressing high morbidity associated with LGS. The treatment was well-tolerated, but monitoring for cardiovascular issues is required due to potential risks.

UCB's commitment to advancing treatments for serious neurological diseases is showcased through new data presented at the 74th American Academy of Neurology (AAN) Annual Meeting. This includes findings related to epilepsy and Parkinson's disease, highlighting the real-world effectiveness of BRIVIACT® in adults with partial-onset seizures, long-term use of FINTEPLA® for Lennox-Gastaut syndrome, and preclinical evaluation of the investigational treatment UCB0599 for Parkinson's disease. UCB also emphasizes its role in enhancing understanding of myasthenia gravis.

UCB announced that the FDA has approved FINTEPLA (fenfluramine) for treating seizures linked to Lennox-Gastaut syndrome (LGS)Dravet syndrome. LGS is a serious childhood-onset epilepsy affecting 30,000 to 50,000 patients in the U.S., characterized by drug-resistant seizures. The FDA approval is supported by a Phase 3 trial showing a significant median drop in seizure frequency of 23.7% with FINTEPLA. The medication is distributed through a restricted program due to safety risks, necessitating ongoing cardiac monitoring.

UCB presented 11 abstracts on bimekizumab for treating adults with moderate to severe plaque psoriasis at the 2022 American Academy of Dermatology Annual Meeting. Pooled data from five Phase 3/3b trials revealed that over 80% of patients who achieved complete skin clearance at week 16 maintained this response for two years. Notably, clinical responses improved for patients switching from secukinumab to bimekizumab. Bimekizumab is currently under FDA review, with its efficacy yet to be established in the U.S.

UCB announced positive topline results from the Phase 3 RAISE trial (NCT04115293) for zilucoplan, a complement C5 inhibitor, in treating generalized myasthenia gravis (gMG). The trial met its primary endpoint, demonstrating significant improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Week 12 compared to placebo. Key secondary endpoints also showed statistically significant improvements. Zilucoplan was well-tolerated, and UCB plans to file for regulatory approval in the US, EU, and Japan later this year.

UCB announced positive top-line results from the Phase 3 BE COMPLETE study, evaluating bimekizumab for active psoriatic arthritis in patients unresponsive to anti-TNF therapy. The study met its primary endpoint, showing significantly more patients achieved at least a 50% improvement in symptoms compared to placebo. All ranked secondary endpoints were also met, demonstrating improvements in physical function and skin clearance. Despite positive outcomes, bimekizumab's safety and efficacy for psoriatic arthritis remain unestablished, with regulatory applications planned for Q3 2022.

UCB has announced a definitive agreement to acquire Zogenix for US$ 26.00 per share, totaling approximately US$ 1.9 billion. The transaction includes a potential cash payment of US$ 2.00 upon EU approval of FINTEPLA® for treating Lennox-Gastaut syndrome (LGS) by December 31, 2023. This acquisition aims to enhance UCB's portfolio in rare epilepsy treatments, particularly for conditions like Dravet syndrome. Both companies' boards have unanimously approved the transaction, which is expected to close by mid-2022, pending regulatory approvals.