Unicycive Therapeutics Has Submitted A New Drug Application To FDA For Oxylanthanum Carbonate For Hyperphosphatemia In Patients With Chronic Kidney Disease On Dialysis, Unicycive Is Seeking FDA Approval Via 505(B)(2) Regulatory Pathway
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Unicycive Therapeutics has submitted a New Drug Application to the FDA for Oxylanthanum Carbonate, targeting hyperphosphatemia in chronic kidney disease patients on dialysis. The company is seeking approval through the 505(B)(2) regulatory pathway.
September 03, 2024 | 11:06 am
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Unicycive Therapeutics has submitted a New Drug Application to the FDA for Oxylanthanum Carbonate, which could potentially treat hyperphosphatemia in chronic kidney disease patients on dialysis. The approval is being sought via the 505(B)(2) regulatory pathway, which may expedite the process.
The submission of a New Drug Application to the FDA is a significant step for Unicycive Therapeutics, as it could lead to the approval of a new treatment for hyperphosphatemia. The use of the 505(B)(2) pathway suggests a potentially faster approval process, which is positive for the company's prospects.
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