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Unicycive Says Suit Alleges Securities Law Violations Over Statements On Oxylanthanum Carbonate FDA Application
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8-K filing — Unicycive Therapeutics, Inc. (UNCY)
Filed: 2026-09-29 AccNo: 0001213900-26-104314 Size: 231 KB Item 5.02: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers Item 8.01: Other Events Item 9.01: Financial Statements and Exhibits
Unicycive Therapeutics Resubmits Its FDA New Drug Application For Oxylanthanum Carbonate For The Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease On Dialysis; Expects PDUFA Date Six Months From Resubmission Date
The Company anticipates United States Food and Drug Administration (FDA) acceptance of the NDA within 30 days and a new assigned PDUFA date to be six months from the date of resubmission.The NDA resubmission includes