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(Reuters) -The U.S. Food and Drug Administration approved Akebia Therapeutics' drug, vadadustat, to treat anemia caused by chronic kidney disease (CKD) in dialysis patients, the drugmaker said on ...
And such was the fate that befell investors of Akebia Therapeutics (AKBA) this week. On Wednesday, the shares crashed by 66% after the FDA rejected the NDA (new drug application) for vadadustat ...
The U.S. health regulator has declined to approve Akebia Therapeutics' drug to treat anemia caused by chronic kidney disease on safety concerns in non-dialysis patients, the company said on Wednesday.
Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease. [2] [3] Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.
Outside of chronic kidney disease, Akebia Therapeutics has reported preliminary findings from its phase II study on Vadadustat for acute respiratory distress syndrome (ARDS) in COVID-19 patients. [5] Based on these results, Akebia Therapeutics plans to proceed with a phase III study targeting a broader ARDS patient population. [6]
This month, we saw the Akebia Therapeutics, Inc. (NASDAQ:AKBA) up an impressive 45%. But that can't change the reality...
The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's (NASDAQ: AKBA) marketing application (NDA) for vadadustat for anemia due to chronic kidney disease (CKD).
CSL Vifor includes also Sanifit Therapeutics from Spain active in the field of calcification disorders in Chronic Kidney Disease. [28] Nephtera is a joint venture with Evotec to build a nephrology therapeutic pipeline.