CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY...
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CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents...
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 Nancy Stuart has been appointed to its Board of Directors effective March 18, 2021. Ms. Stuart is Chief Operating...
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 data presented for its oral drug candidates at the European Academy of Allergy and Clinical Immunology (EAACI) Congress. Data presentations...
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...
CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat, a novel oral plasma kallikrein inhibitor, for symptomatic treatment of acute attacks...
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...
House Minority Leader Bradley H. Jones, Jr. (R-North Reading) has appointed State Rep. Hannah Kane (R-Shrewsbury) to serve as his designee on the newly-established Rare Disease Advisory Council. During the 2019-2020 legislative session, Kane was the lead co-sponsor, along with Representative Joseph McKenna (R-Webster), of legislation calling for the creation...
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...