UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
On November 11, 2024, Unicycive Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration has accepted the New Drug Application for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release of Unicycive Therapeutics, Inc. dated November 11, 2024. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: November 12, 2024
| UNICYCIVE THERAPEUTICS, INC. | ||
| By: | /s/ Shalabh Gupta | |
| Shalabh Gupta | ||
| Chief Executive Officer | ||
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