07/21/23 7:00 AMOTC : UCBJY UCB announces U.S. availability of RYSTIGGO® (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.RYSTIGGO is now commercially available by prescription in the United States for adult patients with gMG who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive 1 RYSTIGGO is the first and only FDA-approved targeted treatment for both anti-AChR Ab+ and anti-MuSK Ab+ adults with gMG 1 ONWARD™, a personalized patient...RHEA-AIneutral
06/27/23 7:00 AMOTC : UCBJY fda approvalUCB announces U.S. FDA approval of RYSTIGGO® (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravisFDA approval of RYSTIGGO ® has been granted under the Priority Review designation for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive 1 U.S. FDA approval is based on the pivotal Phase 3 MycarinG study in gMG 2, a large phase 3 study which...RHEA-AIneutral
04/20/23 7:00 AMOTC : UCBJY UCB Showcases Strength and Depth of Neurology Portfolio at 75th American Academy of Neurology (AAN) Annual MeetingUCB will showcase data from its expansive and innovative neurology portfolio at the 75 th American Academy of Neurology Annual Meeting, April 22-27, 2023. The company will present 12 abstracts, including two oral presentations, across generalized myasthenia gravis, Lennox-Gastaut syndrome, and focal...RHEA-AIpositive
04/17/23 7:14 AMOTC : UCBJY UCB Announces FINTEPLA® (fenfluramine) Oral Solution Is Now Descheduled and Is No Longer Listed as a Controlled SubstanceUCB, a global biopharmaceutical company, today announced the U.S. Drug Enforcement Administration has published a final rule stating that FINTEPLA oral solution is no longer subject to the Controlled Substances Act. "We are pleased that FINTEPLA, which has a unique mechanism of action different from and complementary to other anti-seizure medications, has...RHEA-AIpositive
03/18/23 2:10 PMOTC : UCBJY clinical trialBimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Meaningful, Deep and Maintained Response over 48 WeeksUCB, a global biopharmaceutical company, today announced detailed positive results from two Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa. 1 Data from the two studies showed that bimekizumab achieved...RHEA-AIvery positive
03/16/23 7:00 AMOTC : UCBJY conferencesUCB to Present Eight Bimekizumab Abstracts at AAD 2023 with Results from Studies in Psoriasis, Psoriatic Arthritis, and Hidradenitis SuppurativaUCB, a global biopharmaceutical company, today announced that itRHEA-AInegative
01/18/23 7:00 AMOTC : UCBJY clinical trialAnnals of the Rheumatic Diseases Publishes Results from Two Bimekizumab Phase 3 Studies in Axial SpondyloarthritisUCB, a global biopharmaceutical company, today announced thatRHEA-AIneutral
01/06/23 7:00 AMOTC : UCBJY UCB announces rozanolixizumab BLA for the treatment of generalized myasthenia gravis filed with U.S. FDA and designated for Priority ReviewBiologic License Application (BLA) designated Priority Review by FDA and seeks approval for rozanolixizumab for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetycholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive RozanolixizumabRHEA-AIneutral
12/09/22 7:00 AMOTC : UCBJY clinical trialUCB Announces Positive Phase 3 Studies for Bimekizumab in Hidradenitis SuppurativaTop-line results show that the two Phase 3 studies, BE HEARD I and BE HEARD II, met their primary and key secondary endpoints with statistical significance and consistent clinical relevance First Phase 3 evidence to suggest that targeting IL-17F in addition to IL-17A may be a promising treatmentRHEA-AIpositive
12/07/22 7:00 AMOTC : UCBJY clinical trialThe Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Psoriatic ArthritisUCB, a global biopharmaceutical company,RHEA-AIneutral