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 |
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4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
4 - Unicycive Therapeutics, Inc. (0001766140) (Issuer)
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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
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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
LOS ALTOS, Calif., Oct. 28, 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 an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to
LOS ALTOS, Calif., Aug. 26, 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 September. Event: H.C. Wainwright 27th Annual Global Investment Conference Type: Fireside chatDate/Time: Wednesday, September 10, 2025, at 8:30 a.m. ET Event: Truist Securities Virtual Fireside ChatDate/Time: Wednesday, September 17, 2025, at 10 a.m. ET A link to the live and archived webcast may be accessed on the Unicycive website under the Investors sec
LOS ALTOS, Calif., Aug. 18, 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 the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494. "While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494," said Shalab
- Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC) - OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden - Ended Q2 with $22.3 million of cash with expected runway into the second half of 2026 LOS ALTOS, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney dise
LOS ALTOS, Calif., July 24, 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 the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis in the Clinical Journal of the American Society of Nephrology. The publication, entitled "A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia," examines the safety and tolerability of OLC at clinically effective doses with a goa
LOS ALTOS, Calif., July 08, 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 it has regained compliance with the Nasdaq Stock Market ("Nasdaq") continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications. This update was disclosed in the Company's Current Report on Form 8-K filed on July 8, 2025. On July 7, 2025, the Company received confirmation from the Listing Qualifications Department of Nasdaq that as of July 3, 2025 the Company's common stock has maintained an average closing
LOS ALTOS, Calif., July 07, 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 Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025 at 11 a.m. ET. A link to the 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
--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) --No other concerns stated, including pre-clinical, clinical, or safety data --The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL --The Company plans to immediately request a Type A meeting with the FDA to align on next steps --Unicycive currently has an unaudited cash balance of approximately $20.7 million, with cash runway currently expected into
8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)
8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)
8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)
SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)
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SCHEDULE 13G/A - Unicycive Therapeutics, Inc. (0001766140) (Subject)
8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)
10-Q - Unicycive Therapeutics, Inc. (0001766140) (Filer)
8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)
8-K - Unicycive Therapeutics, Inc. (0001766140) (Filer)
Live Leadership Updates
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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- Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC) - OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden - Ended Q2 with $22.3 million of cash with expected runway into the second half of 2026 LOS ALTOS, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney dise
- 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
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