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Tid*
2024-11-14 - Kvartalsrapport 2024-Q3
2024-08-23 - Kvartalsrapport 2024-Q2
2024-05-03 - Kvartalsrapport 2024-Q1
2024-03-15 - X-dag ordinarie utdelning ALK B 0.00 DKK
2024-03-14 - Årsstämma
2024-02-08 - Bokslutskommuniké 2023
2023-11-15 - Kvartalsrapport 2023-Q3
2023-08-24 - Kvartalsrapport 2023-Q2
2023-05-09 - Kvartalsrapport 2023-Q1
2023-03-20 - X-dag ordinarie utdelning ALK B 0.00 DKK
2023-02-03 - Bokslutskommuniké 2022
2022-11-10 - Kvartalsrapport 2022-Q3
2022-08-11 - Kvartalsrapport 2022-Q2
2022-05-12 - Kvartalsrapport 2022-Q1
2022-03-28 - Split ALK B 1:20
2022-03-17 - X-dag ordinarie utdelning ALK B 0.00 DKK
2022-03-16 - Årsstämma
2022-02-08 - Bokslutskommuniké 2021
2021-11-11 - Kvartalsrapport 2021-Q3
2021-08-11 - Kvartalsrapport 2021-Q2
2021-05-05 - Kvartalsrapport 2021-Q1
2021-03-19 - X-dag ordinarie utdelning ALK B 0.00 DKK
2021-03-18 - Årsstämma
2021-02-10 - Bokslutskommuniké 2020
2020-11-11 - Kvartalsrapport 2020-Q3
2020-08-12 - Kvartalsrapport 2020-Q2
2020-05-06 - Kvartalsrapport 2020-Q1
2020-03-12 - X-dag ordinarie utdelning ALK B 0.00 DKK
2020-03-11 - Årsstämma
2020-02-05 - Bokslutskommuniké 2019
2019-11-07 - Kvartalsrapport 2019-Q3
2019-08-13 - Kvartalsrapport 2019-Q2
2019-05-09 - Kvartalsrapport 2019-Q1
2019-03-14 - X-dag ordinarie utdelning ALK B 0.00 DKK
2019-03-13 - Årsstämma
2019-02-07 - Bokslutskommuniké 2018
2018-11-09 - Kvartalsrapport 2018-Q3
2018-08-15 - Kvartalsrapport 2018-Q2
2018-05-04 - Kvartalsrapport 2018-Q1
2018-03-13 - X-dag ordinarie utdelning ALK B 0.00 DKK
2018-03-12 - Årsstämma
2018-02-06 - Bokslutskommuniké 2017
2017-11-10 - Kvartalsrapport 2017-Q3
2017-08-16 - Kvartalsrapport 2017-Q2
2017-05-09 - Kvartalsrapport 2017-Q1
2017-03-16 - X-dag ordinarie utdelning ALK B 5.00 DKK
2017-03-15 - Årsstämma
2017-02-07 - Bokslutskommuniké 2016
2016-11-10 - Kvartalsrapport 2016-Q3
2016-08-16 - Kvartalsrapport 2016-Q2
2016-05-04 - Kvartalsrapport 2016-Q1
2016-03-11 - X-dag ordinarie utdelning ALK B 5.00 DKK
2016-03-10 - Årsstämma
2016-02-09 - Bokslutskommuniké 2015
2015-11-12 - Kvartalsrapport 2015-Q3
2015-08-18 - Kvartalsrapport 2015-Q2
2015-05-05 - Kvartalsrapport 2015-Q1
2015-03-13 - X-dag ordinarie utdelning ALK B 5.00 DKK
2015-03-12 - Årsstämma
2015-02-09 - Bokslutskommuniké 2014
2014-11-14 - Kvartalsrapport 2014-Q3
2014-08-13 - Kvartalsrapport 2014-Q2
2014-05-08 - Kvartalsrapport 2014-Q1
2014-03-13 - X-dag ordinarie utdelning ALK B 5.00 DKK
2014-03-12 - Årsstämma
2014-02-05 - Bokslutskommuniké 2013
2013-11-08 - Kvartalsrapport 2013-Q3
2013-08-14 - Kvartalsrapport 2013-Q2
2013-05-03 - Kvartalsrapport 2013-Q1
2013-03-13 - X-dag ordinarie utdelning ALK B 5.00 DKK
2013-03-12 - Årsstämma
2013-02-05 - Bokslutskommuniké 2012
2012-11-12 - Kvartalsrapport 2012-Q3
2012-08-16 - Kvartalsrapport 2012-Q2
2012-05-10 - Kvartalsrapport 2012-Q1
2012-03-28 - X-dag ordinarie utdelning ALK B 5.00 DKK
2012-03-27 - Årsstämma
2012-02-22 - Bokslutskommuniké 2011
2011-11-11 - Kvartalsrapport 2011-Q3
2011-08-16 - Kvartalsrapport 2011-Q2
2011-05-10 - Kvartalsrapport 2011-Q1
2011-04-04 - X-dag ordinarie utdelning ALK B 5.00 DKK
2011-04-01 - Årsstämma
2010-03-29 - X-dag ordinarie utdelning ALK B 5.00 DKK

Beskrivning

LandDanmark
ListaLarge Cap Copenhagen
SektorHälsovård
IndustriMedicinteknik
AlK-Abelló är verksamt inom läkemedelsbranschen. Bolaget är en utvecklare av allergi- och immunterapi. Verksamhet innehas på global nivå och produkterna säljs både som vaccin och i tablettform. En stor del av verksamheten fokuserar mot forskning och utveckling inom nämnt arbetsområde, där bolaget aktivt arbetar med diagnostisering och behandling av återkommande allergibesvär. Bolaget grundades 1923 och har sitt huvudkontor i Hørsholm, Danmark.
2024-06-21 18:38:00

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that it has decided to withdraw the Biologic License Application (‘BLA’) for its house dust mite (‘HDM’) sublingual allergy immunotherapy tablet in China. ALK will continue to work with the authorities to obtain regulatory approval of the HDM tablet in China, which may involve establishing additional clinical data in Chinese patients.  

The delay in the regulatory approval process does not impact ALK’s financial guidance for 2024, or its ability to reach a 25% EBIT-margin in 2025. Moreover, it does not impact ALK’s ability to meet its previously communicated long-term financial growth ambitions.

The BLA for the treatment of persistent moderate-to-severe HDM allergic rhinitis in patients aged 12–65 was accepted for review by the Chinese authorities in February 2023. In March 2022, prior to the submission, the authorities issued a clinical trial waiver, allowing ALK to file for approval based on clinical data obtained from patients outside of China, without the need to complete the clinical trial with Chinese subjects, which had been paused in 2020 due to COVID.

Commenting on the decision to withdraw the application, ALK’s Executive Vice President of Research & Development, Henriette Mersebach, says: “We remain committed to bringing innovative treatments to the millions of Chinese people with allergy and their doctors asking for better allergy care. We will work with the authorities in order to resubmit an updated registration application as soon as possible. The continued roll-out of the tablet in certain parts of China’s Medical Pilot Zones is not impacted and continues according to plan. This allows selected prescribers and patients access to care and to gain experience with the treatment.”

ALK’s commercial plans and activities in China will be adapted to a new launch timeline (previously planned for 2025), which will be determined following further dialogue with the authorities. ALK’s current business in China is focused on the injectable SCIT product ALUTARD SQ® which has seen sales growing by 30% p.a. on average in recent years (CAGR 2020-23).

ALK’s HDM tablet is approved in 43 countries across Europe, North America, Middle-East and the Asia Pacific region for the treatment of persistent moderate-to-severe HDM induced allergic rhinitis and in some countries also for the treatment of HDM induced allergic asthma.

ALK-Abelló A/S

For further information please contact:

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

Media: Maiken Riise Andersen, tel. +45 5054 1434

About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.