“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
The contribution of the soluble form of urokinase-type plasminogen activator receptor (suPAR) as a risk factor for chronic kidney diseases (CKD) is well known. Researchers from Rush University Medical Center, Harvard Medical School and collaborators have now identified D2D3, a suPAR fragment, as responsible for causing double injury, both to the kidney and pancreas, thus resulting in glomerular disease and insulin-dependent diabetes.
Awak Technologies Pte Ltd. raised more than $20 million in a series B round that will position the company to potentially transform the management of chronic kidney disease with its wearable and portable peritoneal dialysis (PD) device designed to enable patients with end-stage kidney disease to have dialysis on the go.
Mediwhale Inc. and Yonsei University College of Medicine, Seoul, Republic of Korea, are developing a new predicting tool combining artificial intelligence (AI) and non-invasive retinal eye examination capable of accurately predicting chronic kidney diseases before symptoms appears.
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Given the high prevalence of chronic kidney disease and the impact of renal fibrosis on the prognosis of these patients, there is a need for novel diagnostic tools to be able to detect pathological changes earlier and thus avoid progression to later stages of the disease.
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease that are not on dialysis.
