Latest news with #JohanDighed
Business Upturn
26-05-2025
- Business
- Business Upturn
Karolinska Development's portfolio company Umecrine Cognition resumes patient inclusion in its Phase 1b/2a clinical study
STOCKHOLM, SWEDEN – May 26, 2025. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company Umecrine Cognition has resumed the inclusion of patients to the clinical phase 1b/2a trial evaluating the drug candidate golexanolone in PBC patients. In March, Umecrine Cognition announced that the study had been halted due to technical issues in the production of capsules used in the study, which, however, had no impact on patient safety. Umecrine Cognition is developing a new class of drugs to alleviate cognitive symptoms caused by liver disease. The company's most advanced drug candidate, golexanolone, is currently being evaluated in a randomized, double-blind, placebo-controlled phase 1b/2a clinical study in patients with primary biliary cholangitis (PBC) who experience clinically significant fatigue and cognitive symptoms. Advertisement Karolinska Development's ownership in Umecrine Cognition amounts to 73%. For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: [email protected] Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB Phone: +46 70 207 48 26, e-mail: [email protected] 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 Attachment KD Umecrine Cognition resumes eng Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Yahoo
13-05-2025
- Business
- Yahoo
Karolinska Development's portfolio company OssDsign has treated 10,000 patients with OssDsign Catalyst in the US
STOCKHOLM, SWEDEN, May 13, 2025. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces that its portfolio company OssDsign has reached a new milestone with 10,000 patients treated with the innovative nanosynthetic bone graft OssDsign Catalyst on the US market. OssDsign Catalyst is a nanosynthetic bone graft that demonstrates rapid and robust bone formation, even in poorly vascularized environments. Launched in the US in August 2021, OssDsign Catalyst has since achieved significant success in the American orthobiologics market. 'It is clear that OssDsign Catalyst has solidified its position in the important US market for orthobiological products. The use of the product has doubled since May of last year, when 5,000 patients were reported to have been treated with the product, which is the result of accelerating demand from American surgeons and hospitals,' says Viktor Drvota, CEO of Karolinska Development. Karolinska Development's ownership in OssDsign amounts to 3 %. For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: Johan Dighed, General Counsel and Deputy CEO, Karolinska Development ABPhone: +46 70 207 48 26, e-mail: TO THE EDITORS About Karolinska Development ABKarolinska 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 patients' 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 Attachment PM KD OssDsign 10000 patienter ENGError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-03-2025
- Business
- Yahoo
Karolinska Development's portfolio company PharmNovo receives positive FDA feedback prior to IND application for Phase 2a trial
STOCKHOLM, SWEDEN – March 12, 2025. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that portfolio company PharmNovo received positive feedback regarding its most advanced drug candidate, PN6047, in a pre-IND meeting with the U.S. Food and Drug Administration (FDA). The meeting aimed to provide guidance on the design of the company's planned Phase 2a clinical trial for the treatment of peripheral neuropathy and allodynia. PharmNovo conducted a regulatory pre-IND Type B meeting with the FDA in January 2025. Such meetings are typically held before submitting an Investigational New Drug (IND) application, which is required to conduct clinical studies in the U.S. During the meeting, PharmNovo presented preclinical data, sought advice on its Chemistry, Manufacturing, and Controls (CMC) activities, and received guidance on the design of its planned Phase 2a study for PN6047. FDA did not direct any negative remarks neither concerning the CMC information nor the preclinical data and provided useful guidance for the continued clinical development Based on the feedback, PharmNovo plans to apply for IND approval from FDA before the end of 2025. Furthermore, the company aims to apply for approval to initiate a clinical Phase 2a trial in Europe in the third quartal of 2025. PharmNovo's most advanced drug candidate, PN6047, is a selective delta-opioid receptor agonist (DORA) being developed as a new treatment for complex pain conditions. "Pain management is an area of significant commercial interest. We are therefore very pleased with the outcome of PharmNovo's pre-IND meeting with the FDA and look forward to following the company's continued efforts to launch its planned Phase 2a clinical study," said Viktor Drvota, CEO of Karolinska Development. Karolinska Development's ownership in PharmNovo amounts to 20%.For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: Johan Dighed, General Counsel and Deputy CEO, Karolinska Development ABPhone: +46 70 207 48 26, e-mail: TO THE EDITORS About Karolinska Development ABKarolinska 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 patients' 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 Attachment KD PharmNovo FDA _engSign in to access your portfolio
