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2023-01-17 Karolinska Development AB (publ) Karolinska Development’s portfolio company Umecrine Cognition is granted Orphan Drug Designation by the FDA for golexanolone Pressreleaser Visa Stäng
Pressreleaser | 17 Jan 2023 | Karolinska Development

Karolinska Development’s portfolio company Umecrine Cognition is granted Orphan Drug Designation by the FDA for golexanolone

STOCKHOLM, SWEDEN – January 17, 2023. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company Umecrine Cognition has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the company´s most advanced drug candidate golexanolone in Primary Biliary Cholangitis (PBC). The designation will play a vital role in the planned clinical development of golexanolone.

The U.S. Food and Drug Administration is granting Orphan Drug Designations to investigational therapies addressing rare medical diseases and conditions that affect fewer than 200.000 people in the United States. Umecrine Cognition is developing golexanolone, a new class of drugs being evaluated in primary biliary cholangitis (PBC) and hepatic encephalopathy (HE).

”It is indeed an important and meaningful step forward for Umecrine Cognition to be granted an Orphan Drug Designation for golexanolone in the U.S. The designation will bring our portfolio company great advantages in the clinical development of the drug candidate and moves the project closer to PBC patients with fatigue that today are lacking adequate treatments,” says Viktor Drvota, CEO of Karolinska Development.

Karolinska Development’s ownership in Umecrine Cognition amounts to 70 percent.

For further information, please contact :

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB
Phone: +46 70 207 48 26, e-mail: johan.dighed@karolinskadevelopment.com

TO THE EDITORS

About Karolinska Development AB

Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patient’s lives while providing an attractive return on investment to shareholders.

Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.

Karolinska Development has a portfolio of eleven companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.

The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.

For more information, please visit www.karolinskadevelopment.com .

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2023-01-17 Karolinska Development AB (publ) Karolinska Developments portföljbolag Umecrine Cognition beviljas Orphan Drug Designation av FDA för golexanolon Pressreleaser Visa Stäng
2023-01-12 Karolinska Development AB (publ) Karolinska Developments portföljbolag Aprea Therapeutics doserar första patienten i klinisk fas 1/2a-studie av ATRN-119 Pressreleaser Visa Stäng
2023-01-12 Karolinska Development AB (publ) Karolinska Development’s portfolio company Aprea Therapeutics doses the first patient in a clinical phase 1/2a study of ATRN-119 Pressreleaser Visa Stäng
2023-01-04 Karolinska Development AB (publ) Karolinska Developments portföljbolag OssDsign publicerar patientrapport från TOP FUSION-studien i vetenskaplig tidskrift Pressreleaser Visa Stäng
2023-01-04 Karolinska Development AB (publ) Karolinska Development's portfolio company OssDsign has published a case report from the TOP FUSION study in a scientific journal Pressreleaser Visa Stäng
2023-01-03 Karolinska Development AB (publ) Karolinska Developments portföljbolag Umecrine Cognition presenterar data som visar effekt av golexanolon i en preklinisk modell av Parkinsons sjukdom Pressreleaser Visa Stäng
2023-01-03 Karolinska Development AB (publ) Karolinska Development’s portfolio company Umecrine Cognition presents preclinical data showing effect of golexanolone in a Parkinson’s disease model Pressreleaser Visa Stäng
2022-12-27 Karolinska Development AB (publ) Karolinska Developments portföljbolag Dilafor har slutfört rekryteringen till en förlängningsstudie med tafoxiparin Pressreleaser Visa Stäng
2022-12-27 Karolinska Development AB (publ) Karolinska Development’s portfolio company Dilafor has completed recruitment to an extension study of tafoxiparin Pressreleaser Visa Stäng
2022-12-16 Karolinska Development AB (publ) Karolinska Development's portfolio company OssDsign has presented positive long-term data for OssDsign Cranial PSI Pressreleaser Visa Stäng
2022-12-16 Karolinska Development AB (publ) Karolinska Developments portföljbolag OssDsign redovisar positiva data från långtidsuppföljning med OssDsign Cranial PSI Pressreleaser Visa Stäng
2022-11-29 Karolinska Development AB (publ) Karolinska Developments portföljbolag OssDsign har genomfört en riktad nyemission om cirka 65,6 miljoner kronor Pressreleaser Visa Stäng
2022-11-29 Karolinska Development AB (publ) Karolinska Development's portfolio company OssDsign has completed a directed share issue of approximately SEK 65.6 million Pressreleaser Visa Stäng
2022-11-23 Penser Access Penser Access: Navigerar genom osäkert marknadsklimat - Karolinska Development Analyser Visa Stäng
2022-11-18 Karolinska Development AB (publ) Delårsrapport för januari – september 2022 Pressreleaser Visa Stäng
2022-11-18 Karolinska Development AB (publ) Interim Report - January-September 2022 Pressreleaser Visa Stäng
2022-10-24 Karolinska Development AB (publ) Karolinska Development invests in the Danish dermatology company Henlez Pressreleaser Visa Stäng
2022-10-24 Karolinska Development AB (publ) Karolinska Development investerar i det danska dermatologibolaget Henlez Pressreleaser Visa Stäng
2022-09-28 Karolinska Development AB (publ) Karolinska Developments portföljbolag Umecrine Cognition presenterar positiva prekliniska studieresultat för golexanolon Pressreleaser Visa Stäng
2022-09-28 Karolinska Development AB (publ) Karolinska Development’s portfolio company Umecrine Cognition presents positive results from a preclinical study of golexanolone Pressreleaser Visa Stäng
2022-09-27 Karolinska Development AB (publ) Karolinska Developments portföljbolag Modus Therapeutics har slutfört rekryteringen till en klinisk fas 1b-studie med sevuparin Pressreleaser Visa Stäng
2022-09-27 Karolinska Development AB (publ) Karolinska Development’s portfolio company Modus Therapeutics has completed recruitment in a clinical phase 1b study of sevuparin Pressreleaser Visa Stäng
2022-09-14 Karolinska Development AB (publ) Karolinska Developments portföljbolag Umecrine Cognition säkrar finansiering inför fas 2b-studie av golexanolon i primär biliär kolangit Pressreleaser Visa Stäng
2022-09-14 Karolinska Development AB (publ) Karolinska Development’s portfolio company Umecrine Cognition secures funding ahead of Phase 2 study of golexanolone in primary biliary cholangitis Pressreleaser Visa Stäng
2022-09-07 Karolinska Development AB (publ) Karolinska Development’s portfolio company AnaCardio raises SEK 150 million to start clinical trial with candidate drug AC01 in heart failure Pressreleaser Visa Stäng
2022-09-07 Karolinska Development AB (publ) Karolinska Developments portföljbolag AnaCardio tar in 150 MSEK inför en klinisk studie av AC01 i patienter med hjärtsvikt Pressreleaser Visa Stäng
2022-09-06 Karolinska Development AB (publ) Karolinska Development rekryterar Hans Christopher Toll som ny finansdirektör Pressreleaser Visa Stäng
2022-09-06 Karolinska Development AB (publ) Karolinska Development appoints Hans Christopher Toll as new Chief Financial Officer Pressreleaser Visa Stäng
2022-09-02 Karolinska Development AB (publ) Karolinska Development’s portfolio company Modus Therapeutics initiates inclusion in phase 1 study of sevuparin in pediatric patients with severe malaria Pressreleaser Visa Stäng
2022-09-02 Karolinska Development AB (publ) Karolinska Developments portföljbolag Modus Therapeutics inleder inklusionen till fas 1-studie av sevuparin i pediatriska patienter med svår malaria Pressreleaser Visa Stäng
2022-08-24 Penser Access Penser Access: Adderar ett nytt portföljbolag - Karolinska Development Analyser Visa Stäng
2022-08-19 Karolinska Development AB (publ) Karolinska Developments portföljbolag PharmNovo har inlett det kliniska fas 1-programmet med PN-6047 Pressreleaser Visa Stäng
2022-08-19 Karolinska Development AB (publ) Karolinska Development’s portfolio company has initiated a clinical phase 1 program with PN-6047 Pressreleaser Visa Stäng
2022-08-19 Karolinska Development AB (publ) Delårsrapport för januari – juni 2022 Rapporter Visa Stäng
2022-08-19 Karolinska Development AB (publ) Interim Report - January-June 2022 Rapporter Visa Stäng
2022-08-10 Karolinska Development AB (publ) Karolinska Developments portföljbolag Umecrine Cognition rekryterar Anders Karlsson som ny vd Pressreleaser Visa Stäng
2022-08-10 Karolinska Development AB (publ) Karolinska Development’s portfolio company Umecrine Cognition recruits Anders Karlsson as the new CEO Pressreleaser Visa Stäng
2022-07-22 Karolinska Development AB (publ) Karolinska Developments portföljbolag Promimic bildar joint venture med Danco Medical i USA Pressreleaser Visa Stäng
2022-07-22 Karolinska Development AB (publ) Karolinska Developments portfolio company Promimic and Danco Medical form a joint venture for the US-market Pressreleaser Visa Stäng
2022-07-04 Karolinska Development AB (publ) Karolinska Development expands its portfolio following an investment in PharmNovo Pressreleaser Visa Stäng
2022-07-04 Karolinska Development AB (publ) Karolinska Development utökar portföljen efter genomförd investering i PharmNovo Pressreleaser Visa Stäng
2022-06-27 Karolinska Development AB (publ) Karolinska Development’s portfolio company Svenska Vaccinfabriken presents scientific advancements at international conference Pressreleaser Visa Stäng
2022-06-27 Karolinska Development AB (publ) Karolinska Developments portföljbolag Svenska Vaccinfabriken presenterar vetenskapliga framsteg vid internationell konferens Pressreleaser Visa Stäng
2022-06-23 Karolinska Development AB (publ) Karolinska Development’s portfolio company Promimic presents preclinical results showing decreased bacterial adhesion to implants Pressreleaser Visa Stäng
2022-06-23 Karolinska Development AB (publ) Karolinska Developments portföljbolag Promimic presenterar prekliniska resultat som visar minskad bakterietillväxt på implantat Pressreleaser Visa Stäng
2022-06-03 Karolinska Development AB (publ) Karolinska Development invests in breakthrough drug project for the treatment of nerve pain Pressreleaser Visa Stäng
2022-06-03 Karolinska Development AB (publ) Karolinska Development investerar i banbrytande läkemedelsprojekt för behandling av nervsmärta Pressreleaser Visa Stäng
2022-05-19 Karolinska Development AB (publ) Karolinska Developments portföljbolag Umecrine Cognition ansöker om start av klinisk fas 2-studie med golexanolon Pressreleaser Visa Stäng
2022-05-19 Karolinska Development AB (publ) Karolinska Development's portfolio company Umecrine Cognition submits a Clinical Trial Application to initiate a phase 2 clinical trial with golexanolone Pressreleaser Visa Stäng
2022-05-17 Karolinska Development AB (publ) Karolinska Developments portföljbolag Aprea Therapeutics förvärvar Atrin Pharmaceuticals Pressreleaser Visa Stäng
2022-05-17 Karolinska Development AB (publ) Karolinska Development’s portfolio company Aprea Therapeutics acquires Atrin Pharmaceuticals Pressreleaser Visa Stäng
2022-05-12 Karolinska Development AB (publ) Karolinska Development’s Annual General Meeting 2022 Pressreleaser Visa Stäng
2022-05-12 Karolinska Development AB (publ) Karolinska Developments årsstämma 2022 Pressreleaser Visa Stäng
2022-05-04 Penser Access Penser Access: Odramatiskt kvartal - Karolinska Development Analyser Visa Stäng
2022-05-02 Karolinska Development AB (publ) Karolinska Development’s portfolio company Biosergen prepares Phase 2 study in mucormycosis infected patients Pressreleaser Visa Stäng
2022-05-02 Karolinska Development AB (publ) Karolinska Developments portföljbolag Biosergen förbereder klinisk fas 2-studie med BSG005 mot systemisk svampinfektion Pressreleaser Visa Stäng
2022-04-29 Karolinska Development AB (publ) Karolinska Development’s portfolio company Promimic’s stock starts trading today Pressreleaser Visa Stäng
2022-04-29 Karolinska Development AB (publ) Karolinska Developments portföljbolag Promimics aktie börjar idag handlas på Nasdaq First North Growth Market Pressreleaser Visa Stäng
2022-04-29 Karolinska Development AB (publ) Interim Report - January-March 2022 Pressreleaser Visa Stäng
2022-04-29 Karolinska Development AB (publ) Delårsrapport för januari – mars 2022 Pressreleaser Visa Stäng
2022-04-25 Karolinska Development AB (publ) Karolinska Development’s portfolio company Promimic’s IPO offering fully subscribed Pressreleaser Visa Stäng
2022-04-25 Karolinska Development AB (publ) Karolinska Developments portföljbolag Promimics noteringsemission fulltecknades Pressreleaser Visa Stäng
2022-04-25 Karolinska Development AB (publ) Karolinska Development's portfolio company OssDsign completes patient enrolment to the TOP FUSION study Pressreleaser Visa Stäng
2022-04-25 Karolinska Development AB (publ) Karolinska Developments portföljbolag OssDsign har rekryterat alla patienter till studien TOP FUSION Pressreleaser Visa Stäng
2022-04-12 Karolinska Development AB (publ) Aktieägarna i Karolinska Development AB (publ) kallas till årsstämma Pressreleaser Visa Stäng
2022-04-12 Karolinska Development AB (publ) Notice of Annual General Meeting in Karolinska Development AB (publ) Pressreleaser Visa Stäng
2022-04-04 Karolinska Development AB (publ) Karolinska Developments portföljbolag OssDsign inkluderar första patienten till multicenterregistret PROPEL Pressreleaser Visa Stäng
2022-04-04 Karolinska Development AB (publ) Karolinska Development's portfolio company OssDsign enrolls the first patient to the multi-center registry PROPEL Pressreleaser Visa Stäng

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