Chronic Kidney Disease

ProKidney (NASDAQ:PROK) Class A stock experienced a surge of 8.58% in its after-hours trading, continuing its climb of over 500% during regular trading on Tuesday. What Happened: Following the release of positive results from its Phase 2 trial, the after-hours trading of ProKidney stock saw an...

Novo Nordisk A/S (NYSE: NVO) shares got a boost this week after the drugmaker halted trials testing potential treatment for kidney failure on early signs of efficacy. The study has implications for other drugmakers including Eli Lilly And Co (NYSE: LLY) and DaVita...

The FDA has issued a Complete Response Letter (CRL) regarding Reata Pharmaceuticals Inc's (NASDAQ: RETA) application seeking approval for bardoxolone methyl for chronic kidney disease (CKD) caused by Alport syndrome. The agency concluded that it does not believe the...

Reata Pharmaceuticals Inc (NASDAQ: RETA) shares are trading lower during the market trading session after the FDA released briefing documents ahead of the Advisory Committee meeting scheduled on December 08 for marketing application for the kidney disease drug bardoxolone methyl....

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) claimed its second early-stage win after announcing positive results in a small study of VX-147 on a genetically defined form of chronic kidney disease. The 16-patient, Phase 2 trial focused on patients with focal segmental...

GlaxoSmithKline plc (NYSE: GSK) announced positive results from the ASCEND program comprised of five Phase 3 studies assessing daprodustat for anemia due to chronic kidney disease (CKD). Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (...

The FDA has approved Cara Therapeutics Inc (NASDAQ: CARA) and Vifor Pharma AG’s Korsuva (difelikefalin) injection for severe-to-moderate pruritis (itching) in patients with chronic kidney disease (CKD) undergoing dialysis. Difelikefalin is an opioid agonist that...

The FDA has issued a complete response letter regarding the marketing application for FibroGen Inc's (NASDAQ: FGEN) roxadustat for anemia of chronic kidney disease (CKD). The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested an...

A trial has been launched to assess the antibody response of the third dose of COVID-19 messenger RNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna Inc (NASDAQ: MRNA) or Pfizer Inc (NYSE: PFE) - BioNTech SE (NASDAQ:...

Roth Capital initiated coverage of Unicycive Therapeutics (NASDAQ: UNCY) with a Buy rating and $13.50 price target.  Analyst Elemer Piros says that the Company could submit a marketing application to the FDA for Renasorb to treat hyperphosphatemia in chronic...

The European Union has approved AstraZeneca plc’s (NASDAQ: AZN) Forxiga (dapagliflozin) for chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). Forxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The approval is based on positive results...

The FDA has issued a Complete Response Letter (CRL) to Ardelyx Inc's (NASDAQ: ARDX) marketing application seeking approval for tenapanor to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. While the FDA agrees that "the...

Three months after revealing that the FDA had asked for more information to support tenapanor application for a chronic kidney disease drug, the FDA issued a letter to Ardelyx Inc (NASDAQ: ARDX) identifying deficiencies in its application ahead of its PDUFA date next week...

DiaMedica Therapeutics Inc (NASDAQ: DMAC) has announced positive interim results from its Phase 2 REDUX trial of DM199 in chronic kidney disease (CKD).  The trial is designed to evaluate the effect of DM199 across three cohorts, including African Americans (AA), non-diabetic...

OPKO Health Inc's (NASDAQ: OPK) subsidiary EirGen Pharma has agreed to develop and commercialize Rayaldee to treat secondary hyperparathyroidism in patients with stage 3/4 chronic kidney disease with Nicoya Therapeutics in Greater China. Nicoya will make an...