UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: GlobeNewswire
FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027 LOS ALTOS, Calif., Jan. 29, 2026 (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 the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) 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. The Agency has deemed the OLC resubmission to be a Class II complete response which has a six-month review period from the date of resubmission and set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. “We are pleased that the agency has promptly accepted the resubmissio
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News
- Unicycive: 'Buy' Rating On NDA Resubmission OLC And Potential Best-In-Class Profile [Seeking Alpha]Seeking Alpha
- Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission [Yahoo! Finance]Yahoo! Finance
- Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) ResubmissionGlobeNewswire
- Unicycive Therapeutics (NASDAQ:UNCY) had its "buy" rating reaffirmed by analysts at Guggenheim.MarketBeat
- Unicycive resubmits NDA for hyperphosphatemia asset [Seeking Alpha]Seeking Alpha
UNCY
Sec Filings
- 1/23/26 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form 8-K
- UNCY's page on the SEC website