Key Developments: Alk Abello A/S (ALKb.CO)

ALKb.CO on Copenhagen Stock Exchange

710.00DKK
16 Apr 2014
Price Change (% chg)

kr.26.00 (+3.80%)
Prev Close
kr.684.00
Open
kr.690.00
Day's High
kr.722.00
Day's Low
kr.690.00
Volume
30,891
Avg. Vol
13,581
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kr.789.00
52-wk Low
kr.396.00

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Latest Key Developments (Source: Significant Developments)

Alk Abello raises low end of prior FY 2014 EBITDA guidance
Monday, 14 Apr 2014 06:05pm EDT 

Alk Abello A/S:Expects FY 2014 operating profit (EBITDA) to be 375-400 million Danish crowns (previously 300-400 million crowns ) before special items, income from product supply, and potential sales royalties in North America.  Full Article

Alk Abello A/S announces FDA approval for Merck’s grass sublingual allergy immunotherapy tablet GRASTEK (GRAZAX)
Monday, 14 Apr 2014 05:55pm EDT 

Alk Abello A/S:Announces that the US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for Merck’s grass sublingual allergy immunotherapy (SLIT) tablet GRASTEK.GRASTEK is the US trade name of the grass SLIT-tablet which is licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX.GRASTEK is an allergen extract.In the USA, GRASTEK is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.GRASTEK is approved for use in persons 5 through 65 years of age.GRASTEK is not indicated for the immediate relief of allergic symptoms.  Full Article

Alk Abello A/S announces Merck initiates Phase III clinical development programme for treatment of house dust mite-induced respiratory diseases
Thursday, 20 Mar 2014 03:09am EDT 

Alk Abello A/S:Strategic partner, Merck (known as MSD outside the USA and Canada), is advancing clinical development programme for house dust mite (HDM) SLIT-tablet by initiating Phase III clinical trial in USA and Canada.HDM SLIT-tablet is ALK's new allergy immunotherapy tablet for treatment of HDM-induced respiratory diseases.Trial is expected to include about 1,500 subjects and will investigate safety and efficacy of the tablet in treatment of HDM-induced allergic rhinitis in North American patients.  Full Article

Alk Abello raises lower end of FY 2014 EBITDA guidance
Thursday, 20 Mar 2014 03:03am EDT 

Alk Abello A/S:Expects 2014 operating profit (EBITDA) to be 300-400 million Danish crowns (previously 225-400 million crowns) before special items-Reuters.  Full Article

Alk Abello's partner for Japan reports positive trial results for house dust mite SLIT-tablet
Monday, 10 Mar 2014 03:00am EDT 

Alk Abello A/S:Says its partner for Japan, Torii Pharmaceutical Co., Ltd., has reported positive results from its Phase II/III trial into ALK’s sublingual allergy immunotherapy tablet (SLIT-tablet) for house dust mite-induced allergic rhinitis (hay fever).Says the trial met its primary efficacy endpoint by showing a significantly lower ‘Total Combined Rhinitis Score’ (TCRS) when compared with patients who received placebo.Says the trial also showed that the treatment was well tolerated and had a favourable safety profile.  Full Article

Alk Abello's partner Merck presents data on investigational house dust mite sublingual allergy immunotherapy tablet
Tuesday, 4 Mar 2014 05:30pm EST 

Alk Abello A/S:Says ALK's partner in North America, Merck & Co Inc, known as MSD outside the USA and Canada, presents new data from a Phase IIb trial with its investigational sublingual house dust mite allergy immunotherapy tablet.Says the data is presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, USA.Says the trial results showed that both doses of active treatment significantly reduced the average total nasal symptom score compared to placebo in adults with house dust mite-induced allergic rhinitis.  Full Article

Alk Abello proposes FY 2013 dividend of DKK 5 per share
Wednesday, 5 Feb 2014 02:31am EST 

Alk Abello A/S:Proposes FY 2013 dividend of 5 Danish crowns per share.Says dividend payment date is Mar. 18th.Says the proposed dividend is unchanged from the dividend of 5 Danish crowns per share paid for FY 2012.  Full Article

Alk Abello issues FY 2014 outlook below analysts' estimates
Wednesday, 5 Feb 2014 02:31am EST 

Alk Abello A/S:Expects FY 2014 revenue to grow and EBITDA to increase.Estimates FY 2014 EBITDA to be 225-400 million Danish crowns before special items and income from product supply and potential sales royalties in North America.Estimates FY 2014 revenue, excluding SLIT-tablets and related milestone payments in North America, to be 2.15-2.2 billion Danish crowns.FY 2014 EBITDA 421.29 million Danish crowns, revenue 2,446 million Danish crowns - Thomson Reuters I/B/E/S Estimates.  Full Article

Alk's partner Merc announces launch of GRASTEK (GRAZAX) in Canada
Monday, 3 Feb 2014 08:02am EST 

Alk Abello A/S:Says the company's grass sublingual allergy immunotherapy tablet, which is licensed to Merck for North America, has been launched in Canada.Says marketed in Europe under the brand name GRAZAX, the product is known in Canada as GRASTEK.Says the launch announcement follows regulatory approval from the Canadian authorities of the New Drug Submission (NDS).  Full Article

Alk Abello says FDA Advisory Committee recommends approval of GRASTEK
Thursday, 12 Dec 2013 04:00pm EST 

Alk Abello A/S:Says FDA Advisory Committee meeting unanimously recommends approval of GRASTEK (GRAZAX).Says in the committee's opinion the available data support the efficacy and safety of Merck’s GRASTEKTM in patients aged five to 65 years and recommends that adrenaline auto-injectors should be made available for patients at home.Says GRASTEKTM is the proposed US trade name of the grass sublingual allergy immunotherapy tablet, licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX.  Full Article

UPDATE 2-NORDIC STOCKS - Factors to watch on April 15

(Adds Aker Solutions, Alma Media and Norsk Hydro, updates H&M and SKF)

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