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 Chron...
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: Yahoo! Finance
therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. “With this NDA submission, we are excited to be one step closer to our goal of bringing OLC to patients with chronic kidney disease who are living with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe our data support a differentiated and best-in-class therapy that will maintain phosphate control while reducing the onerous pill burden patients currently have to manage. Over the last several months, our team has worked diligently to reach this milestone, and we are now preparing to launch OLC, if approved. We are also pleased to report tha
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News
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) had its "speculative buy" rating re-affirmed by analysts at Benchmark Co.. They now have a $3.00 price target on the stock.MarketBeat
- Unicycive Therapeutics to Participate in Two Upcoming Investor Conferences Including a Fireside Chat at the Piper Sandler 36th Annual Healthcare ConferenceGlobeNewswire
- Unicycive Announces Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $2.50 price target on the stock.MarketBeat
- 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 DialysisGlobeNewswire
UNCY
Sec Filings
- 11/21/24 - Form EFFECT
- 11/15/24 - Form EFFECT
- 11/14/24 - Form SC
- UNCY's page on the SEC website