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 Kidn...
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: GlobeNewswire
– FDA sets PDUFA Action Date of June 28, 2025 – Company Preparing for 2025 Commercial Launch – LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. “We are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “CKD patients on dialysis with hyp
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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 Delivers Multiple Poster Presentations Highlighting Development Progress on Oxylanthanum Carbonate (OLC) and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024 [Yahoo! Finance]Yahoo! Finance
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