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H Lundbeck A/S (LUN.CO)

LUN.CO on Copenhagen Stock Exchange

286.50DKK
14 Dec 2018
Change (% chg)

kr.2.90 (+1.02%)
Prev Close
kr.283.60
Open
kr.289.00
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kr.291.80
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kr.280.50
Volume
704,431
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459,179
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kr.477.70
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kr.252.30

Latest Key Developments (Source: Significant Developments)

Lundbeck And Otsuka Report Positive Phase II Data For Brexpiprazole And Sertraline
Friday, 30 Nov 2018 

Nov 30 (Reuters) - H Lundbeck A/S ::REG-LUNDBECK AND OTSUKA REPORT POSITIVE PHASE II DATA FOR THE COMBINATION TREATMENT OF BREXPIPRAZOLE AND SERTRALINE FOR THE TREATMENT OF POST-TRAUMATIC STRESS DISORDER (PTSD).REG-LUNDBECK AND OTSUKA REPORT POSITIVE PHASE II DATA FOR THE COMBINATION TREATMENT OF BREXPIPRAZOLE AND SERTRALINE FOR THE TREATMENT OF POST-TRAUMATIC STRESS DISORDER (PTSD).COMPANIES WILL DISCUSS RESULTS WITH FDA AT AN END-OF-PHASE-II MEETING IN 2019.COMBINATION TREATMENT ARM OF BREXPIPRAZOLE AND SERTRALINE DEMONSTRATED IMPROVEMENT IN SYMPTOMS OF PTSD VERSUS PLACEBO (P<0.01) ON PRIMARY EFFICACY ENDPOINT.EFFICACY OF COMBINATION ARM OVER PLACEBO WAS ALSO SUPPORTED BY DATA FROM MULTIPLE SECONDARY ENDPOINTS.EFFICACY OF COMBINATION ARM OVER PLACEBO WAS ALSO SUPPORTED BY DATA FROM MULTIPLE SECONDARY ENDPOINTS.COMPANIES PLAN TO MEET WITH U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO DISCUSS RESULTS OF PHASE II STUDY.  Full Article

Lundbeck Q3 EBIT Above Estimates At DKK 1.45 Billion
Wednesday, 7 Nov 2018 

Nov 7 (Reuters) - H Lundbeck A/S ::REG-LUNDBECK REALIZED 12% GROWTH IN REVENUE (LOCAL CURRENCIES) AND 56% GROWTH IN EPS IN 9M 2018. GUIDANCE FOR FY2018 RAISED.REG-LUNDBECK REALIZED 12% GROWTH IN REVENUE (LOCAL CURRENCIES) AND 56% GROWTH IN EPS IN 9M 2018. GUIDANCE FOR FY2018 RAISED.FINANCIAL GUIDANCE FOR 2018 IS RAISED.Q3 EBIT DKK 1.45 BILLION (REUTERS POLL DKK 1.44 BILLION).NOW EXPECTS REVENUE TO REACH DKK 17.7 - 18.1 BILLION AND PROFIT FROM OPERATIONS (EBIT) TO REACH DKK 5.1 - 5.4 BILLION FOR 2018.Q3 REVENUE DKK 4.63 BILLION (REUTERS POLL DKK 4.68 BILLION).SEES PROFIT FROM OPERATIONS (EBIT) TO REACH DKK 5.1 - 5.4 BILLION FOR 2018.FOR THE FULL YEAR 2018 GUIDANCE IS REVISED FOLLOWING BETTER-THAN-EXPECTED SALES PERFORMANCE.SIGNIFICANT DECLINE OF ONFI HAS TO BE EXPECTED STARTING IN Q4 2018 AND CONTINUING INTO 2019.  Full Article

Lundbeck Phase III Study For Lu Af35700 In Treatment-Resistant Schizophrenia Misses Endopoint
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - H Lundbeck A/S ::REG-LUNDBECK UPDATES ON CLINICAL PHASE III STUDY FOR LU AF35700 IN TREATMENT-RESISTANT SCHIZOPHRENIA.* LU AF35700 DID NOT SHOW STATISTICAL SUPERIORITY VERSUS CONVENTIONAL THERAPY ON PRIMARY ENDPOINT (CHANGE IN TOTAL PANSS) IN PATIENTS WITH TREATMENT-RESISTANT SCHIZOPHRENIA (TRS).LU AF35700 SHOWED GOOD ANTI-PSYCHOTIC EFFECTS, WAS WELL-TOLERATED AND SAFE AT 10 MG AND 20 MG DOSAGES IN STUDY.FURTHER ANALYSIS OF DATA IS ONGOING.FIRST PHASE III STUDY FOR LU AF35700 DID NOT MEET PRIMARY ENDPOINT OF STATISTICAL SUPERIORITY VERSUS CONVENTIONAL THERAPY.  Full Article

Takeda And Lundbeck Submit New Drug Application (NDA) For Vortioxetine In Japan
Friday, 28 Sep 2018 

Sept 28 (Reuters) - Lundbeck ::REG-TAKEDA AND LUNDBECK SUBMIT NEW DRUG APPLICATION (NDA) FOR VORTIOXETINE IN JAPAN FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD).PIVOTAL PHASE III STUDY DEMONSTRATED POSITIVE RESULTS OF VORTIOXETINE AS COMPARED TO PLACEBO FOR TREATMENT OF MDD IN JAPANESE ADULTS.AND TAKEDA WILL CO-COMMERCIALIZE VORTIOXETINE IN JAPAN ONCE APPROVED.PIVOTAL PHASE III STUDY DEMONSTRATED POSITIVE RESULTS OF VORTIOXETINE AS COMPARED TO PLACEBO FOR TREATMENT OF MDD IN JAPANESE ADULTS.  Full Article

Lundbeck To Market Brintellix Strongly In China - Interim CEO
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - H Lundbeck A/S ::SAYS WILL MARKET NEWLY LAUNCHED DRUGS BRINTELLIX AND AZILECT STRONGLY IN CHINA.SAYS THAT SHOULD CONTRIBUTE TO THE EXPECTED DOUBLING OF TOTAL REVENUE IN CHINA WITHIN THE NEXT 5-10 YEARS.SAYS STILL GROWTH IN CIPRALEX/LEXAPRO SALES IN CHINA AND JAPAN EVEN THOUGH THE PATENT ON THE DRUG HAS EXPIRED.  Full Article

Lundbeck Q2 EBIT, Reveue Beat Estimates
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - H Lundbeck A/S ::REG-LUNDBECK REALIZED 14% GROWTH IN REVENUE (LOCAL CURRENCIES) AND 83% GROWTH IN EPS.FINANCIAL GUIDANCE FOR 2018 IS REVISED.NOW EXPECTS REVENUE TO REACH DKK 17.6-18.0 BILLION COMPARED TO PREVIOUSLY DKK 17.2-18.0 BILLION..REVENUE REACHED DKK 9,288 MILLION IN FIRST SIX MONTHS OF 2018.EBIT IS NOW EXPECTED TO REACH DKK 4.9-5.2 BILLION COMPARED TO PREVIOUSLY DKK 4.8-5.2 BILLION.SAYS SALES IN SECOND HALF OF 2018 WILL BE SOMEWHAT LOWER THAN REALIZED IN FIRST HALF OF YEAR."WE EXPECT INCREASED GENERIC EROSION AND DESTOCKING.".Q2 REVENUE DKK 4.70 BILLION (REUTERS POLL DKK 4.55 BILLION).Q2 EBIT DKK 1.35 BILLION (REUTERS POLL DKK 1.19 BILLION).  Full Article

Otsuka Holdings unit Otsuka Pharmaceutical and Lundbeck’s Rxulti® (brexpiprazole) approved by European Commission
Tuesday, 31 Jul 2018 

July 31(Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says its wholly owned unit Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S (Lundbeck) today announce that the European Commission has approved Rxulti® (brexpiprazole) for the treatment of schizophrenia in adults.  Full Article

Deborah Dunsire Named New President And CEO Of Lundbeck
Monday, 2 Jul 2018 

July 2 (Reuters) - H Lundbeck A/S ::REG-DR. DEBORAH DUNSIRE NAMED NEW PRESIDENT AND CEO OF LUNDBECK.DR. DUNSIRE WILL TAKE UP HER NEW POSITION ON 1 SEPTEMBER 2018.FROM 1 SEPTEMBER 2018, ANDERS GÖTZSCHE, INTERIM CEO AND CFO IN LUNDBECK WILL RESUME HIS POSITION AS CFO FOR COMPANY.  Full Article

Lundbeck Reaches Voluntary Agreement In Principle With U.S. DOJ
Wednesday, 6 Jun 2018 

June 6 (Reuters) - H Lundbeck A/S ::REACHES VOLUNTARY AGREEMENT IN PRINCIPLE WITH U.S. DEPARTMENT OF JUSTICE.AS PART OF AGREEMENT, LUNDBECK LLC WILL PAY DOJ $52.6 MILLION (APPROXIMATELY DKK 336 MILLION).AGREEMENT WILL HAVE NO INFLUENCE ON LUNDBECK'S GUIDANCE FOR 2018, WHICH WAS PROVIDED ON 7 FEBRUARY 2018.  Full Article

Otsuka Holdings unit and Lundbeck to start third phase 3 trial to evaluate brexpiprazole in treatment of agitation in patients with Alzheimer's disease
Thursday, 24 May 2018 

May 24 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says co's unit Otsuka Pharmaceutical Co Ltd and Lundbeck announce that the two companies' third clinical phase 3 study ofbrexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type will commence in June.  Full Article

UPDATE 3-J&J unit to pay $360 mln to U.S. to resolve charity kickback probe

BOSTON, Dec 6 A Johnson & Johnson unit will pay the U.S. government $360 million to resolve an investigation into its financial support of a charity that helped Medicare patients cover out-of-pocket drug costs, the Justice Department said on Thursday.