CAMBRIDGE, Mass. & SALISBURY, England – KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, announced today that the U.S. Food and Drug Administration (FDA) has notified the Company in a letter that it has placed a...
treatment News
CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced positive results from the phase 3 KONFIDENT clinical trial demonstrating statistically and clinically significant efficacy of sebetralstat as oral on-demand...
STOCKHOLM, SWEDEN – Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that its portfolio company Umecrine Cognition has published results from the recently conducted phase 2a study of the drug candidate golexanolone in the highly regarded scientific journal Journal of Hepatology. The study results show that the company’s drug candidate...
STOCKHOLM, SWEDEN – Karolinska Development AB (Nasdaq Stockholm: KDEV) announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aprea Therapeutics’ drug candidate eprenetapopt for the treatment of acute myeloid leukemia (AML). KDev Investments, a company jointly owned by Karolinska Development and Rosetta Capital, holds...
Stockholm, Sweden – Ozempic and other GLP1 agonists are associated with a reduced risk of developing cirrhosis and liver cancer in people with type 2 diabetes and chronic liver disease, according to a nationwide study from Karolinska Institutet in Sweden published in the journal Gut. GLP1 agonists like Ozempic reduce...
– Menarini Group Obtains Exclusive Rights to Commercialize NEXPOVIO for the Treatment of Hematologic and Solid Tumor Oncology Indications in Europe (including the United Kingdom), Latin America and Other Key Countries – Karyopharm to Receive $75 Million Upfront, then Eligible to Receive Up to $202.5 Million in Future Milestones, Plus Tiered, Double-digit Royalties on Net Sales NEWTON, Mass. and FLORENCE, Italy,...
NEWTON, Mass. – Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Company’s Type II Variation Marketing Authorization Application (MAA), which seeks to expand the currently authorized indication for NEXPOVIO® in the European Union to...
NEWTON, Mass. – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that health-related quality of life (HRQoL) data from the Phase 3 portion of the SEAL (Selinexor in Advanced Liposarcoma) study were published online in Future Oncology. The SEAL study evaluated twice weekly, single...
NEWTON, Mass. – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Commission (EC) has granted conditional marketing authorization for NEXPOVIO (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple...
NEWTON, Mass. – Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that on May 26, 2021 the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization for NEXPOVIO® (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in...