GlobeNewswire by notified

ALK giver opdatering på registreringsprocessen for tabletten mod husstøvmideallergi i Kina

Del

ALK (ALKB:DC / OMX: ALK B / AKBLF) har i dag annonceret, at selskabet har besluttet at trække sin registreringsansøgning for tabletten mod husstøvmideallergi. ALK vil fortsat samarbejde med myndighederne for at opnå godkendelse af tabletten mod husstøvmideallergi i Kina, hvilket kan medføre yderligere kliniske data i kinesiske patienter.

Forsinkelsen i den regulatoriske godkendelsesproces har ikke indflydelse på ALKs forventninger til 2024 eller for selskabets muligheder for at opnå en EBIT-margin på 25% in 2025. Desuden påvirker forsinkelsen ikke ALKs muligheder for leve op til selskabets langsigtede finansielle vækstambitioner som tidligere kommunikeret.

Registreringsansøgningen vedrørende behandling af vedvarende moderat til svær allergisk rhinitis forårsaget af husstøvmider i 12-65-årige patienter blev accepteret til behandling af de kinesiske myndigheder i februar 2023. I marts 2022, forud for indsendelsen, gav de kinesiske myndigheder ALK dispensation, således at ALK kunne indsende registreringsansøgningen på basis af data fra kliniske forsøg uden for Kina uden at afslutte det lokale kliniske studie, som måtte sættes på pause i 2020 på grund af COVID.

Henriette Mersebach, ALKs koncerndirektør for Forskning & Udvikling, kommenterer på beslutningen om at trække ansøgningen: “Vi er forsat fast besluttede på at bringe nye innovative behandlinger til de millioner af kinesere, som lever med allergi, og til deres læger, som ønsker bedre allergibehandling. Vi vil samarbejde med myndighederne med henblik på at genindsende en opdateret registreringsansøgning så hurtigt som muligt. Den fortsatte udrulning af tabletten i visse dele af Kinas såkaldte Medical Pilot Zones er ikke påvirket og fortsætter efter planen. Dette vil give udvalgte læger og patienter adgang til behandlingen og til at få erfaringer hermed.”

ALKs kommercielle planer og aktiviteter i Kina vil blive tilpasset en ny lanceringstidslinje (tidligere planlagt til 2025), som vil blive fastlagt efter yderligere dialog med myndighederne. ALKs aktuelle forretning i Kina er fokuseret på det injektionsbaserede ALUTARD SQ®, hvor salget i gennemsnit er vokset med 30% årligt i de seneste år (CAGR 2020-23).

ALKs tablet mod husstøvmideallergi er godkendt i 43 lande på tværs af Europa, Nordamerika, Mellemøsten samt Asien og Stillehavsområdet til behandling af vedvarende moderat til svær allergisk rhinitis og i visse land også til behandling af allergisk astma forårsaget af husstøvmider.

ALK-Abelló A/S

Yderligere oplysninger kan fås ved henvendelse til:
Investor Relations: Per Plotnikof, tlf. +45 4574 7527, mobil +45 2261 2525
Medier: Maiken Riise Andersen, tlf. +45 5054 1434

Om ALK
ALK er en specialiseret global lægemiddelvirksomhed med fokus på allergi og allergisk astma. Virksomheden markedsfører allergivaccination og andre produkter og services til mennesker med allergi og allergilæger. ALK har hovedkontor i Hørsholm og beskæftiger omkring 2.900 medarbejdere på verdensplan. Selskabet er noteret på Nasdaq Copenhagen. Læs mere på www.alk.net.

Den danske meddelelse er en oversættelse af den engelske meddelelse. Den engelske meddelelse er den til enhver tid gældende version.

Vedhæftet fil

Følg pressemeddelelser fra GlobeNewswire by notified

Skriv dig op her, og modtag pressemeddelelser på e-mail. Indtast din e-mail, klik på abonner, og følg instruktionerne i den udsendte e-mail.

Flere pressemeddelelser fra GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye