Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) [Yahoo! Finance]
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: Yahoo! Finance
LOS ALTOS, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC), the Company's investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. “Our original third-party manufacturing vendor has made significant progress toward regaining FDA compliance, allowing us to resubmit the OLC NDA as planned,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With a cash runway into 2027, we are well-positioned to complete the regulatory approval process for OLC so we can prepare to bring this important treatment option to dialysis patients with hyperphosphatemia as soon as possible.” The N
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News
- Companies Like Unicycive Therapeutics (NASDAQ:UNCY) Are In A Position To Invest In Growth [Yahoo! Finance]Yahoo! Finance
- Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)GlobeNewswire
- 2025 Forbes Healthcare Summit | How To Make Medicine Personal [Forbes]Forbes
- Unicycive Therapeutics (NASDAQ:UNCY) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Unicycive Therapeutics to Participate in Upcoming Investor Events in December [Yahoo! Finance]Yahoo! Finance
UNCY
Analyst Actions
- 10/29/25 - HC Wainwright
UNCY
Sec Filings
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form 8-K
- 11/14/25 - Form 424B5
- UNCY's page on the SEC website