DUBLIN – Health care investor Syncona Ltd. has founded a new startup, Purespring Therapeutics Ltd., to take gene therapy into the kidney. It is committing £45 million (US$59.6 million) in series A funding, which will support the build-out of the new company and take at least one program into the clinic.
Calliditas Therapeutics AB, filled with confidence by positive top-line results from a phase III trial of its oral budesonide, Nefecon, in patients with primary immunoglobulin A nephropathy (IgAN), said it plans to seek accelerated approval for the drug from the FDA in the first quarter of 2021.
DUBLIN – Vifor Pharma Group is paying $60 million, including $30 million up front and $30 million in equity investment, to secure rights to Angion Biomedica Corp.’s hepatocyte growth factor mimetic, ANG-3777, in all nephrology indications.
Shares of Tricida Inc. (NASDAQ:TCDA) fell 47.2% to $4.37 on Oct. 29 after the company said the FDA would require data on how veverimer, its investigational therapy for metabolic acidosis in patients with chronic kidney disease (CKD), impacts CKD progression to support an accelerated approval. The news followed a complete response letter that met the NDA in August.
Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA is proposing its withdrawal from the U.S. market because the required postmarketing study didn’t show clinical benefit.
Mallinckrodt plc’s decade-long frustration with getting approval for its vasopressin analogue selective for V1 receptors, terlipressin, for use in hepatorenal syndrome type 1 continues as the FDA issued the company a third complete response letter (CRL) for the drug.
With the PDUFA date for relugolix against prostate cancer growing nearer and data in castration resistance-free patients closer still, Myovant Sciences GmbH aims to wring more from the oral, once-daily gonadotropin-releasing hormone receptor antagonist, studying it in uterine fibroids and endometriosis.
Akebia Therapeutics Inc. CEO John Butler said “a clear path forward” exists for vadadustat in chronic kidney disease (CKD) despite negative phase III safety findings, and the company plans to file for approval as early as next year in the U.S. and Europe.
As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo.
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