Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
Despite hitting a phase III study’s primary and key secondary endpoints for treating diabetic kidney disease, Reata Pharmaceuticals Inc. is discontinuing its bardoxolone programs for the indication. The data that disappointed Reata were, after three years of treatment, finding no separation in end-stage renal disease events between the bardoxolone and placebo groups.
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. It also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization.
Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. It also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization.
Human Immunology Biosciences Inc. (Hi-Bio) is moving ahead to late-stage work after disclosing positive phase II data from two trials testing the monoclonal antibody felzartamab for primary membranous nephropathy (PMN), a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome. CEO Travis Murdoch told BioWorld that his firm is “working through designs for the next study, and planning to engage with regulators,” after which more details will be shared. PMN, he added, has “not been heavily trodden, but increasingly there’s a recognition that there’s an important patient and commercial opportunity” in the indication.
The long-running Makena saga came to a close April 6 with the U.S. FDA announcing its decision to immediately withdraw approval of the drug and its generics – the only drugs indicated in the U.S. to reduce the risk of preterm birth.
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