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United Kingdom

Ucb SA (UCB.BR)

UCB.BR on Brussels Stock Exchange

72.44EUR
17 Jul 2019
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Latest Key Developments (Source: Significant Developments)

UCB Nayzilam Nasal Spray Approved By FDA
Monday, 20 May 2019 

May 20 (Reuters) - UCB SA ::UCB ANNOUNCES NAYZILAM® (MIDAZOLAM) NASAL SPRAY NOW APPROVED BY FDA TO TREAT INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PEOPLE LIVING WITH EPILEPSY IN THE U.S..NAYZILAM IS THE FIRST NEW MEDICATION APPROVED TO TREAT SEIZURE CLUSTERS IN MORE THAN 20 YEARS IN THE U.S.  Full Article

U.S. FDA Says Granted Approval Of Evenity To Amgen
Tuesday, 9 Apr 2019 

April 9 (Reuters) - U.S. Food and Drug Administration::U.S. FDA- GRANTED APPROVAL OF EVENITY TO AMGEN.U.S. FDA - EVENITY COMES WITH A BOXED WARNING.  Full Article

UCB To Provide Additional Information To FDA Regarding Midazolam Nasal Spray Submission
Monday, 1 Apr 2019 

April 1 (Reuters) - UCB SA ::UCB TO PROVIDE ADDITIONAL INFORMATION TO THE US FDA REGARDING MIDAZOLAM NASAL SPRAY SUBMISSION.FDA REQUEST FOR ADDITIONAL INFORMATION IS NOT RELATED TO THE SAFETY OR EFFICACY DATA SUBMITTED TO SUPPORT THE APPLICATION.UCB WILL WORK WITH FDA TO DETERMINE NEXT STEPS AND WILL MAKE SURE TO PROVIDE THEM WITH THE SPECIFIC INFORMATION THEY NEED.  Full Article

FDA Approves Cimzia Injection For Treatment For Patients With A Type Of Inflammatory Arthritis
Thursday, 28 Mar 2019 

March 28 (Reuters) - U.S. Food and Drug Administration::FDA - APPROVED CIMZIA INJECTION FOR TREATING ADULTS WITH CERTAIN TYPE OF INFLAMMATORY ARTHRITIS CALLED NR-AXSPA, WITH OBJECTIVE SIGNS OF INFLAMMATION.FDA - GRANTED APPROVAL OF CIMZIA TO UCB.FDA SAYS NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (NR-AXSPA) IS A TYPE OF INFLAMMATORY ARTHRITIS THAT CAUSES INFLAMMATION IN SPINE AND OTHER SYMPTOMS.FDA - CIMZIA PRESCRIBING INFORMATION INCLUDES BOXED WARNING TO ADVISE ABOUT INCREASED RISK OF SERIOUS INFECTIONS INCLUDING TUBERCULOSIS, BACTERIAL SEPSIS.FDA - CIMZIA PRESCRIBING INFORMATION INCLUDES BOXED WARNING TO ADVISE ABOUT INCREASED RISK OF SERIOUS INFECTIONS INCLUDING INVASIVE FUNGAL INFECTIONS.  Full Article

UCB FY Net Sales Went Up By 5% To 4.41 Billion Euros
Thursday, 28 Feb 2019 

Feb 28 (Reuters) - UCB SA ::FY REVENUE REACHED € 4.6 BILLION: +2%, +5% CER1; NET SALES INCREASED TO € 4.4 BILLION: +5%, +8% CER, DRIVEN BY CORE PRODUCTS (+6%, +10% CER).FINANCIAL OUTLOOK FOR 2019: REVENUE EXPECTED IN THE RANGE OF € 4.6 - 4.7 BILLION.OUTLOOK 2019 RECURRING EBITDA2 IN THE RANGE OF 27% - 29% OF REVENUE.FY UNDERLYING PROFITABILITY (REBITDA) INCREASED TO € 1 398 MILLION: 2%, +5% CER.FOR FY, PROPOSES DIVIDEND OF EUR 1.21 PER SHARE (GROSS), +2.5%.FY CIMZIA NET SALES EUR 1.45 BILLION VERSUS EUR 1.42 BILLION YEAR AGO.FY VIMPAT NET SALES EUR 1.1 BILLION VERSUS EUR 976 MILLION YEAR AGO.FY BRIVIACT NET SALES EUR 142 MILLION VERSUS EUR 87 MILLION YEAR AGO.FY NEUPRO NET SALES EUR 321 MILLION VERSUS EUR 314 MILLION YEAR AGO.FY KEPPRA NET SALE EUR 790 MILLION VERSUS EUR 778 MILLION YEAR AGO.FY EBIT EUR 1.10 BILLION VERSUS EUR 1.09 BILLION YEAR AGO.CIMZIA IS EXPECTED TO REACH € 1.7 BILLION BY 2024.VIMPAT SHOULD REACH 1.4 BILLION BY 2022.FY PROFIT EUR 823 MILLION VERSUS EUR 771 MILLION YEAR AGO.  Full Article

UCB Phase 2B Study Of DZP In SLE: Primary Endpoint Not Met
Tuesday, 23 Oct 2018 

Oct 23 (Reuters) - UCB SA ::TOPLINE RESULTS FROM A PHASE 2B STUDY OF DAPIROLIZUMAB PEGOL IN SLE.PRIMARY ENDPOINT OF THE STUDY WAS NOT MET.STUDY DID DEMONSTRATE CONSISTENT AND POTENTIALLY MEANINGFUL IMPROVEMENTS FOR THE MAJORITY OF CLINICAL ENDPOINTS IN PATIENTS TREATED WITH DZP COMPARED WITH PLACEBO.DZP WAS WELL TOLERATED AND DEMONSTRATED AN ACCEPTABLE SAFETY PROFILE..BIOMARKER DATA DEMONSTRATED EVIDENCE OF PROOF OF BIOLOGY..  Full Article

UCB Announces It Has Received Transparency Notification From Blackrock Dated 11 Sept
Friday, 14 Sep 2018 

Sept 14 (Reuters) - UcB SA ::UCB ANNOUNCES THAT IT HAS RECEIVED TRANSPARENCY NOTIFICATION FROM BLACKROCK DATED 11 SEPT.UCB SAYS BLACKROCK NOTIFIED THAT AFTER BUYING UCB SHARES, ITS TOTAL HOLDING IN CO HAS INCREASED AND HAS CROSSED THE 5 PERCENT THRESHOLD ON 10 SEPTEMBER 2018.  Full Article

UCB Granted Orphan Drug Designation For Treatment Of Intermittent Bouts Of Increased Seizure Activity
Monday, 13 Aug 2018 

Aug 13 (Reuters) - UCB SA ::GRANTED ORPHAN DRUG DESIGNATION FOR TREATMENT OF INTERMITTENT BOUTS OF INCREASED SEIZURE ACTIVITY.GRANTED ORPHAN DRUG DESIGNATION FOR TREATMENT OF INTERMITTENT BOUTS OF INCREASED SEIZURE ACTIVITY.MIDAZOLAM NASAL SPRAY HAS ALSO BEEN GRANTED FAST TRACK DESIGNATION BY THE US FDA DUE TO THE HIGH UNMET NEED FOR PATIENTS AND CAREGIVERS.MIDAZOLAM NASAL SPRAY HAS BEEN GRANTED ORPHAN DRUG DESIGNATION BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (US FDA) .  Full Article

UCB H1 Profit up at EUR 574 MLN
Thursday, 26 Jul 2018 

July 26 (Reuters) - UCB SA ::H1 REVENUE REACHED EUR 2.27 BILLION: +2%, +6% CER; NET SALES INCREASED TO EUR 2.15 BILLION: +5%, +10% CER.FINANCIAL OUTLOOK FOR 2018 CONFIRMED.H1 UNDERLYING PROFITABILITY (REBITDA) INCREASED TO EUR 794 MILLION: 7%, +12% CER.H1 PROFIT OF THE GROUP INCREASED TO EUR 574 MILLION (FROM EUR 451 MILLION) OF WHICH EUR 551 (+28%; +33% CER) MILLION IS ATTRIBUTABLE TO THE UCB SHAREHOLDERS.  Full Article

Amgen, UCB Resubmit Biologics License Application For Evenity To U.S. FDA
Friday, 13 Jul 2018 

July 13 (Reuters) - AMGEN INC ::AMGEN AND UCB RESUBMIT BIOLOGICS LICENSE APPLICATION (BLA) FOR EVENITY™ (ROMOSOZUMAB) TO THE US FDA.  Full Article

UPDATE 2-European shares dip on pharma drag as Fed optimism sizzles out

* Bank-heavy Milan and Marid stocks outperform (Recasts, updates to close, changes quote)