Unicycive Therapeutics, Inc., a biotechnology company, engages in developing novel therapies for kidney diseases in the United States. It is developing Renazorb for treatment of hyperphosphatemia in patients with chronic kidney disease; and UNI 494, for treatment of acute kidney injury. The company was incorporated in 2016 and is based in Los Altos, California.
IPO Year: 2021
Exchange: NASDAQ
Website: unicycive.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/21/2025 | $6.00 | Buy | Guggenheim |
| 4/4/2024 | $9.00 | Overweight | Piper Sandler |
| 8/9/2021 | $13.50 | Buy | Roth Capital |
- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025 - New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial
LOS ALTOS, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present at the 24th Annual Needham Virtual Healthcare Conference on Monday, April 7, at 2:15 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 request a 1x1 meeting with management, please contact your Needham representative. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments f
- Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis under review by the FDA with a PDUFA target action date of June 28, 2025 - Commercial planning in preparation for anticipated commercial launch of OLC in late 2025 LOS ALTOS, Calif., March 31, 2025 (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 December 31, 2024, and provided a business update. "2025 is positioned to be a transformational year for Unicycive, with the near-term potential for
LOS ALTOS, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the publication of preclinical data describing the benefits of combination treatment of oxylanthanum carbonate (OLC) and tenapanor on phosphate management in the American Society of Nephrology (ASN) journal, Kidney360. The publication, entitled "Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats," examines the potential synergistic benefits of a combination of OLC, a phosphate binder, with tenapanor, a sodium/hydrogen exchanger 3 (NHE3) inhibito
LOS ALTOS, Calif., Jan. 07, 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 data from the Company's oxylanthanum carbonate (OLC) Phase 1 dose escalation study in healthy volunteers was published in the peer-reviewed journal, Clinical and Translational Science. The publication, entitled "Safety and Phosphate-Binding Capacity of Oxylanthanum Carbonate in Healthy Volunteers," described a study evaluating the safety of escalating doses of OLC (500 mg, 1,000 mg, 1,500 mg, or 2,000 mg administered three times a day). In the trial,
LOS ALTOS, Calif., Dec. 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 that data from the Company's oxylanthanum carbonate (OLC) bioequivalence study in healthy volunteers was published in the peer-reviewed journal, Clinical Therapeutics. The publication, entitled, "Two-Way Randomized Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate" described the study that established pharmacodynamic (PD) bioequivalence of OLC to Fosrenol®. In the study, OLC was well t
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. Event:Noble Capital Markets 20th Annual Emerging Growth Equity ConferenceType:Corporate PresentationDate/Time:Tuesday, December 3, 2024 at 3:00 p.m. ETLocation:Boca Raton, FL Event:Piper Sandler 36th Annual Healthcare ConferenceType:Fireside ChatDate/Time:Thursday, December 5, 2024 at 12:30 p.m. ETLocation:New York, NY Links to the live an
– 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. "We are pleased with the
– 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. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on
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. A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations. An archive of the webcast will be available for three months. About Unicycive Therapeutics Unicycive Therapeutics is a biotechnolog
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- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025 - New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial
- Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis under review by the FDA with a PDUFA target action date of June 28, 2025 - Commercial planning in preparation for anticipated commercial launch of OLC in late 2025 LOS ALTOS, Calif., March 31, 2025 (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 December 31, 2024, and provided a business update. "2025 is positioned to be a transformational year for Unicycive, with the near-term potential for
– 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. "We are pleased with the
– 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. "Achieving successful results from our oxylanthanum carbonate (OLC) pivotal trial was a significant milestone for the company and brings us one step closer to becoming a commercial organization," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. "Impor
– 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., June 25, 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 positive results from the Oxylanthanum Carbonate (OLC) UNI-OLC-201 pivotal clinical trial with regard to both safety and tolerability endpoints. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being develo
– On Track to Provide Topline Data from the Ongoing Pivotal Clinical Trial with Oxylanthanum Carbonate (OLC) in Q2 2024 – – Multiple Presentations on OLC and UNI-494 at Prominent, Upcoming Medical Meetings – LOS ALTOS, Calif., May 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 March 31, 2024, and provided a business update. "This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OL
– 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. "The last several months have been extremely productive for Unicycive as we advanced both of our clinical development programs
Reached Alignment with the FDA on the Data Package Requirements to File NDA for oxylanthanum carbonate (OLC) OLC Pivotal Clinical Trial Expected to Initiate Before Year End LOS ALTOS, Calif., Nov. 14, 2023 (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 third quarter ended September 30, 2023, and provided a business update. "Gaining alignment with the FDA on our clinical development plan for oxylanthanum carbonate (OLC) was a major achievement as we are one step closer to potentially bringing a much-nee
Recent Data Publications Highlight the Benefits of Oxylanthanum Carbonate (OLC) to Improve Medication Adherence and Quality of Life for Patients with Chronic Kidney Disease Feedback from FDA Expected in Fall 2023 for OLC Program UNI-494 Phase 1 Trial Progressing as Planned with IND Application Expected in 2024 LOS ALTOS, Calif., Aug. 14, 2023 (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 second quarter ended June 30, 2023, and provided a business update. "Data publications and presentat
ORLANDO, FL / ACCESSWIRE / July 21, 2023 / RedChip Companies previously announced it would air interviews with 60 Degrees Pharmaceuticals, Inc. and Unicycive Therapeutics, Inc. (NASDAQ:UNCY) on The RedChip Money Report® on Bloomberg TV, this Saturday, July 22, at 7 p.m. Eastern Time (ET). The Unicycive Therapeutics interview that had been scheduled to air was recorded prior to the company's recent interactions with the U.S. Food and Drug Administration (FDA or Agency) concerning the company's New Drug Application (NDA) for lanthanum dioxycarbonate (LDC), previously known as Renazorb. LDC is an investigational new drug being developed for the treatment of hyperphosphatemia in chronic kidney d
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LOS ALTOS, Calif., Sept. 06, 2023 (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 appointment of Sara Kenkare-Mitra, PhD to the Company's Board of Directors, effective September 6, 2023. As a veteran of the biotech and pharmaceutical industry, we believe Sara's leadership and experience in drug development spanning more than 25 years will significantly help bolster Unicycive's future growth. "We are thrilled to welcome Dr. Kenkare-Mitra to our Board of Directors and know that her extensive drug development and corporate leadersh
LOS ALTOS, Calif., Oct. 26, 2021 /PRNewswire/ -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the appointment of Douglas Jermasek as Executive Vice President, Corporate Strategy. In this role, Mr. Jermasek, a seasoned healthcare professional, will have responsibility for Unicycive's corporate and commercial strategy and business development activities. Doug has spent the majority of his career focused on drugs for treatment of kidney diseases"With a career spent in heal
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Guggenheim initiated coverage of Unicycive Therapeutics with a rating of Buy and set a new price target of $6.00
Piper Sandler initiated coverage of Unicycive Therapeutics with a rating of Overweight and set a new price target of $9.00
Roth Capital initiated coverage of Unicycive Therapeutics with a rating of Buy and set a new price target of $13.50