Unicycive Therapeutics

Unicycive Therapeutics, Inc. engages in the development of treatment for kidney diseases. Its products include UNI-494, Renazorb, and UNI-220. The company was founded by Shalabh Gupta on August 18, 2016 and is headquartered in Los Altos, CA.

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LOS ALTOS, Calif., Nov. 21, 2024 (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 upcoming investment conferences in December.

Unicycive Therapeutics to Participate in Two Upcoming Investor Conferences Including a Fireside Chat at the Piper Sandler 36th Annual Healthcare Conference

– OLC New Drug Application (NDA) Accepted by the FDA with a PDUFA Target Action Date of June 28, 2025– – Commercial Planning in Progress for 2025 Launch – – Late Breaker Poster Presentation on OLC at ASN Kidney Week – – Successful Completion of UNI-494 Phase 1 Trial – LOS ALTOS, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended September 30, 2024, and provided a business update.

Unicycive Announces Third Quarter 2024 Financial Results and Provides Business Update

– FDA sets PDUFA Action Date of June 28, 2025 – Company Preparing for 2025 Commercial Launch – LOS ALTOS, Calif., Nov. 11, 2024 (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 the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.

Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

– Late-Breaker Poster Presentation Highlights Favorable Safety & Tolerability of OLC – – Two Publications Recently Issued Featuring OLC and UNI-494 – LOS ALTOS, Calif., Oct. 28, 2024 (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 multiple presentations were delivered at the American Society of Nephrology (ASN) Kidney Week 2024 that highlighted the extensive development progress for both oxylanthanum carbonate (OLC) and UNI-494.

Unicycive Therapeutics Delivers Multiple Poster Presentations Highlighting Development Progress on Oxylanthanum Carbonate (OLC) and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024

LOS ALTOS, Calif., Oct. 16, 2024 (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 2024 Maxim Healthcare Virtual Summit on Thursday, October 17, 2024 at 10:00 a.m. ET.

Unicycive Therapeutics to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024

LOS ALTOS, Calif., Oct. 14, 2024 (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 a poster presentation on oxylanthanum carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Unicycive will also deliver three additional poster presentations on OLC and UNI-494. The conference will take place October 24-27, 2024 in San Diego, CA.

Unicycive Therapeutics Announces Late-Breaker Poster Presentation on Oxylanthanum Carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024

UNI-494 was Well-Tolerated as a Single Dose up to 160 mg and in Multiple Doses at 40 mg Twice-a-Day UNI-494 was Well-Tolerated as a Single Dose up to 160 mg and in Multiple Doses at 40 mg Twice-a-Day

Unicycive Therapeutics Successfully Completes UNI-494 Phase 1 Study in Healthy Volunteers

LOS ALTOS, Calif., Sept. 24, 2024 (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 virtual Lytham Partners Fall 2024 Investor Conference on Tuesday, October 1, 2024 at 11:00 a.m. ET.

Unicycive Therapeutics to Participate in a Fireside Chat at the Virtual Lytham Partners Fall 2024 Investor Conference on October 1, 2024

LOS ALTOS, Calif., Sept. 16, 2024 (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 a corporate update at the Virtual Life Sciences Investor Forum on Thursday, September 19, 2024 at 2:00 p.m. ET in New York, NY.

Unicycive Therapeutics to Present at the Virtual Life Sciences Investor Forum on September 19, 2024

LOS ALTOS, Calif., Sept. 05, 2024 (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 a corporate update at the H.C. Wainwright 26th Annual Global Investment Conference on Tuesday, September 10, 2024 at 10:30 a.m. ET in New York, NY.

Unicycive Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference

LOS ALTOS, Calif., Sept. 03, 2024 (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 the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway.

Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

LOS ALTOS, Calif., Aug. 26, 2024 (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 three poster presentations will be delivered on the Company's product candidates at the American Society of Nephrology (ASN) Kidney Week 2024 taking place October 24-27, 2024 in San Diego, CA.

Unicycive Therapeutics to Present Three Posters at the American Society of Nephrology (ASN) Kidney Week 2024

– On Track to Submit OLC New Drug Application (NDA) by End of August 2024 – LOS ALTOS, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2024, and provided a business update.

Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update

LOS ALTOS, Calif., July 17, 2024 (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 the issuance of U.S. Patent No.

Unicycive Therapeutics Granted Patent on UNI-494 to Treat Acute Kidney Injury by the United States Patent and Trademark Office (USPTO)

LOS ALTOS, Calif., July 11, 2024 (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 H.C. Wainwright 3rd Annual Kidney Virtual Conference on Monday, July 15, 2024 at 2:00 p.m. ET.

Unicycive Therapeutics to Participate in Fireside Chat at the H.C. Wainwright 3rd Annual Kidney Virtual Conference

– Patients preferred OLC more than 4 to 1 over their prior phosphate binder therapy – – Median daily pill burden reduced by half after switch to OLC – LOS ALTOS, Calif., July 10, 2024 (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 the initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial.

Unicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)

LOS ALTOS, Calif., July 01, 2024 (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 it was included in the Russell Microcap Index at the conclusion of the 2024 Russell US Indexes annual reconstitution, effective at the open of US equity markets on Monday, July 1, 2024.

Unicycive Therapeutics Joins Russell Microcap® Index

– Successfully Established Favorable Tolerability and Safety of OLC – – New Drug Application (NDA) Submission Anticipated in Q3 2024 – – Webcast and Conference Call Today at 8:30 A.M. ET – LOS ALTOS, Calif.

Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial

– Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor –

Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress

LOS ALTOS, Calif., May 23, 2024 (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 virtual Lytham Partners Spring 2024 Investor Conference on Thursday, May 30, 2024, at 9:30 a.m. ET.

Unicycive Therapeutics to Participate in a Fireside Chat at the Lytham Partners Spring 2024 Investor Conference

– OLC Demonstrates Bioequivalence to Lanthanum Carbonate – – Additional Poster Highlights Key Features of OLC as Perceived by Renal Dieticians – LOS ALTOS, Calif., May 15, 2024 (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 two posters related to the Company's lead product candidate, oxylanthanum carbonate (OLC), were presented at the National Kidney Foundation (NKF) Spring Clinical Meeting.

Unicycive Therapeutics Presents Bioequivalence Data on Oxylanthanum Carbonate (OLC) at the National Kidney Foundation Spring Clinical Meeting

– On Track to Provide Topline Data from the Ongoing Pivotal Clinical Trial with Oxylanthanum Carbonate (OLC) in Q2 2024 –

Unicycive Announces First Quarter 2024 Financial Results and Provides Business Update

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LOS ALTOS, Calif., April 10, 2024 (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 a company update at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on Thursday April 18, 2024 at 11:00 a.m. ET.

Unicycive Therapeutics to Present at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

– Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 – – UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of Acute Kidney Injury – – UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete – LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

News for Unicycive Therapeutics Stock (UNCY)