Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
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Unicycive Therapeutics announced that the FDA has accepted their NDA for Oxylanthanum Carbonate, a treatment for hyperphosphatemia in dialysis patients, with a PDUFA date set for June 28, 2025. The company is preparing for a commercial launch in 2025.
November 11, 2024 | 12:15 pm
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Unicycive Therapeutics' NDA for Oxylanthanum Carbonate has been accepted by the FDA, with a PDUFA date set for June 28, 2025. The company is gearing up for a commercial launch in 2025.
The acceptance of the NDA by the FDA is a significant milestone for Unicycive Therapeutics, indicating potential future revenue from the drug if approved. The set PDUFA date provides a timeline for investors, and the preparation for a commercial launch suggests confidence in approval, likely boosting investor sentiment.
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