UNCY

LOS ALTOS, Calif., April 09, 2026 (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 Shalabh Gupta, M.D., Chief Executive Officer, will present at the 25th Annual Needham Virtual Healthcare Conference on Wednesday, April 15, 2026, at 3:45 p.m. ET. A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead investi

8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)

8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)

Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million, with expected runway into 2027 LOS ALTOS, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended D

10-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)

SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)

SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)

SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)

LOS ALTOS, Calif., Feb. 04, 2026 (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 Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on Wednesday, February 11, 2026, at 1:30 p.m. ET. A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. To schedule a 1x1 meeting with management, please contact your Guggenheim conference representative. About Unicycive Therapeutics Uni

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. Th

DA assigns Prescription Drug User Fee Act (PDUFA) target date of June 27, 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

SCHEDULE 13G - Unicycive Therapeutics, Inc. (0001766140) (Subject)

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

LOS ALTOS, Calif., Nov. 25, 2025 (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 Shalabh Gupta, M.D., Chief Executive Officer, will participate in two investor events in December. Event: Piper Sandler 37th Annual Healthcare ConferenceType: Fireside chatDate/Time: Wednesday, December 3, 2025, at 10:00 a.m. ET Event: Noble Capital Markets Virtual PresentationDate/Time: Wednesday, December 10, 2025, at 10:00 a.m. PT A link to the live and archived Piper Sandler webcast, as well as an archived link of the Noble presentation, may be

8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)

424B5 - Unicycive Therapeutics, Inc. (0001766140) (Filer)

SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)

SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)

SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)

8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)

-   Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end -   Presented new analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count (2x) compared to currently available phosphate binders -   Ended Q3 with $42.7 million of cash with expected runway into 2027 LOS ALTOS, Calif., Nov. 12, 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 its financial results for t

10-Q - Unicycive Therapeutics, Inc. (0001766140) (Filer)

LOS ALTOS, Calif., Nov. 03, 2025 (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 Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim 2nd Annual Healthcare Innovation Conference on Monday, November 10, 2025, at 3:30 p.m. ET. A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. To schedule a 1x1 meeting with management, please contact your conference representative. About Unicycive Therapeutics Unicyc

LOS ALTOS, Calif., Oct. 30, 2025 (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 it will present new oxylanthanum carbonate (OLC) data at the American Society of Nephrology (ASN) Kidney Week 2025, which will take place in Houston, TX, from November 5-9, 2025. "Treatment with our investigational phosphate binder OLC led to clinically meaningful and statistically significant reductions in pill burden in terms of both volume and number of pills, giving us even more conviction about the potential benefits and convenience OLC may offe

8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)