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Ucb SA (UCB.BR)

UCB.BR on Brussels Stock Exchange

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Latest Key Developments (Source: Significant Developments)

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

UCB Announces Briviact® (Brivaracetam) Now Approved By FDA To Treat Partial-Onset (Focal) Seizures In Pediatric Epilepsy Patients
Monday, 14 May 2018 

Ucb SA ::UCB ANNOUNCES BRIVIACT® (BRIVARACETAM) NOW APPROVED BY FDA TO TREAT PARTIAL-ONSET (FOCAL) SEIZURES IN PEDIATRIC EPILEPSY PATIENTS.  Full Article

UCB Announces Positive CHMP Opinion For Cimzia®
Friday, 27 Apr 2018 

April 27 (Reuters) - UCB SA ::UCB ANNOUNCES POSITIVE CHMP OPINION FOR CIMZIA® (CERTOLIZUMAB PEGOL) IN PATIENTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS.EUROPEAN COMMISSION’S ENDORSEMENT OF CHMP POSITIVE OPINION FOR PSORIASIS EXPECTED IN Q2.CHMP POSITIVE OPINION IS BASED ON DATA FROM A PHASE 3 CLINICAL DEVELOPMENT PROGRAM CONSISTING OF CIMPASI-1, CIMPASI-2 AND CIMPACT.THIS WOULD FURTHER BROADEN CLINICAL VALUE OF CIMZIA.  Full Article

UCB Q1 Revenue Down At 1.07 Billion Euros
Wednesday, 25 Apr 2018 

April 25 (Reuters) - Ucb SA ::Q1 REVENUE REACHED € 1.07 BILLION: -5%, -1% CER;.FINANCIAL OUTLOOK 2018 CONFIRMED: REVENUE EXPECTED TO REACH € 4.5 - 4.6 BILLION.FINANCIAL OUTLOOK 2018 CONFIRMED: RECURRING EBITDA SHOULD REACH € 1.3 - 1.4 BILLION.Q1 VIMPAT SALES EUR 242 MILLION VERSUS EUR 239 MILLION YEAR AGO.Q1 NEUPRO SALES EUR 71 MILLION VERSUS EUR 74 MILLION YEAR AGO.Q1 KEPPRA SALES EUR 189 MILLION VERSUS EUR 210 MILLION YEAR AGO.Q1 REVENUE EUR 1.07 BILLION VERSUS EUR 1.12 BILLION YEAR AGO.Q1 CIMZIA SALES EUR 310 MILLION VERSUS EUR 317 MILLION YEAR AGO.CORE EARNINGS PER SHARE ARE EXPECTED IN THE RANGE OF € 4.30 – 4.70 IN 2018.  Full Article

UCB Acquires Midazolam Nasal Spray From Proximagen
Friday, 20 Apr 2018 

April 20 (Reuters) - UCB SA UCB.BR::UCB TO EXPAND EPILEPSY PORTFOLIO WITH STRATEGIC ACQUISITION OF MIDAZOLAM NASAL SPRAY FROM PROXIMAGEN.UCB WILL MAKE AN UPFRONT CASH PAYMENT OF $150 MILLION.MIDAZOLAM NASAL SPRAY (USL261) COMPLETED PHASE 3 CLINICAL DEVELOPMENT AND IS READY TO BE FILED AS A NEW DRUG APPLICATION (NDA) IN 2018.IN ADDITION, PROXIMAGEN IS ELIGIBLE TO RECEIVE CONTINGENT PAYMENTS OF UP TO $220 MILLION BASED ON CERTAIN REGULATORY APPROVAL AND SALES-BASED MILESTONES.TRANSACTION IS EXPECTED TO CLOSE IN Q2 OF 2018.USL261 ALREADY GRANTED ORPHAN DRUG AND FAST TRACK DESIGNATION BY US FDA.  Full Article

UPDATE 2-Amgen's postmenopausal osteoporosis drug wins FDA panel backing

Jan 16 An advisory panel to the U.S. Food and Drug Administration said on Wednesday that benefits of Amgen Inc's osteoporosis treatment for postmenopausal women at high risk for fracture outweighed its risks and overwhelmingly voted for the drug's approval.