Unicycive Therapeutics announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration for Oxylanthanum Carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies, multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on UNCY:
- Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
- Unicycive Therapeutics to Present Three Posters at the American Society of Nephrology (ASN) Kidney Week 2024
- Unicycive price target lowered to $2.50 from $4.50 at H.C. Wainwright
- Unicycive Therapeutics reports Q2 EPS (15c), consensus (19c)
- Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update