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)... Read More

Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025 LOS ALTOS, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will implement a 1-for-10 reverse split of the issued shares of its common stock, effective at 4:01 p.m. Eastern Time on June 18, 2025.... Read More

The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug... Read More

LOS ALTOS, Calif., May 22, 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 two upcoming virtual investment conferences. Event: Lytham Partners Spring 2025 Investor Conference Type: Fireside Chat Date/Time: Thursday, May 29, 2025,... Read More

LOS ALTOS, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) (“Unicycive” or the “Company”), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced a change in the time of the 2025 Annual Meeting of Stockholders (the “Annual Meeting”). The previously announced date of the meeting (June 9, 2025) and location of the meeting (4300 El... Read More

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... Read More

Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use Results to be presented in poster sessions... Read More

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 24 th 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... Read More

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... Read More

LOS ALTOS, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with... Read More

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.... Read More

LOS ALTOS, Calif., Jan. 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 the publication of a review on patient perspectives regarding phosphate management in the peer-reviewed journal, Journal of Nephrological Science. The publication, entitled “Patient... Read More

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... Read More

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,... Read More

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 20 th Annual Emerging Growth Equity... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

LOS ALTOS, Calif., Oct. 09, 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 successful completion of the UNI-494 Phase 1 study in healthy volunteers. “We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps... Read More

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.... Read More

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,... Read More

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 26 th Annual Global Investment Conference on Tuesday, September 10, 2024 at 10:30... Read More

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... Read More

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... Read More

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... Read More

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. 12,036,211 by the United States Patent and Trademark Office (USPTO) for UNI-494. The patent, valid until 2040, secures protection of a method of treating a... Read More

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. A... Read More

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... Read More

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. The... Read More

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... Read More

Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor Oral UNI-494 Shows Promise in a Preclinical Model as a Potential Candidate for Prevention of Delayed Graft Function Related to Acute Kidney Injury LOS ALTOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for... Read More

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.... Read More

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... Read More

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... Read More

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... Read More

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... Read More

LOS ALTOS, Calif., March 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 that multiple presentations will be delivered on the Company’s product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61 st European Renal Association (ERA) Congress taking... Read More

LOS ALTOS, Calif., March 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 that the Company has entered into a securities purchase agreement with certain healthcare-focused institutional investors for the sale of 50,000 shares of its Series B Convertible... Read More

Promising Preclinical Results in Delayed Graft Function of Acute Kidney Injury UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete LOS ALTOS, Calif., March 13, 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 presentations related to... Read More

LOS ALTOS, Calif., March 07, 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 enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based... Read More

LOS ALTOS, Calif., March 04, 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 has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. UNI-494 is... Read More

LOS ALTOS, Calif., Feb. 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 two posters related to the Company’s lead product candidate, oxylanthanum carbonate (OLC), will be presented at the National Kidney Foundation Spring Clinical Meeting taking place May... Read More

LOS ALTOS, Calif., Jan. 29, 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 presentations related to UNI-494 will be presented at the 29 th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024 taking place March 12-15, 2024, in... Read More

Topline Data from OLC Pivotal Trial Expected in Q2 2024 OLC will target the multibillion-dollar hyperphosphatemia market LOS ALTOS, Calif., Jan. 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 issued a letter to shareholders. Dear Shareholders: As I sit down to write this... Read More

LOS ALTOS, Calif., Dec. 18, 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 enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based... Read More

LOS ALTOS, Calif., Nov. 29, 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 that Shalabh Gupta, M.D., Chief Executive Officer will participate in two upcoming investor conferences in December 2023. Noble Capital Markets 19th Annual Emerging Growth Equity Conference... Read More

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... Read More

Pivotal clinical trial expected to initiate before year end LOS ALTOS, Calif., Oct. 23, 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 Company has reached alignment with the U.S. Food and Drug Administration (FDA) on the path forward for Oxylanthanum Carbonate... Read More

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... Read More

LOS ALTOS, Calif., Aug. 29, 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 that Shalabh Gupta, M.D., Chief Executive Officer was recently featured on the Nasdaq Amplify Issuer Spotlight interview series. The series explores how industry leaders within small-cap... Read More

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... Read More

LOS ALTOS, Calif., July 20, 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 that Shalabh Gupta, M.D., Chief Executive Officer will participate in a fireside chat at the H.C. Wainwright 2nd Annual Kidney Conference “Glomerular Disease: IgAN Is Just the Tip of the... Read More

LOS ALTOS, Calif., July 18, 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 that the peer-reviewed international journal the American Journal of Nephrology has published positive results on the phosphate binding capacity for oxylanthanum carbonate (OLC). The Company... Read More

LOS ALTOS, Calif., June 29, 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 provided an update based on 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),... Read More

LOS ALTOS, Calif., June 16, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced today that Company CEO, Shalabh Gupta, MD, has been invited to present at the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest, on Tuesday, June 20th to Thursday, June 22 nd at 9:00 A.M.... Read More

Closed on previously announced transformational fundraising that included $30 million financing upfront with up to an additional $100 million tied to the satisfaction of milestones Continued progress with plan to file New Drug Application with the U.S. Food and Drug Administration in Q3 2023, with the potential for approval and launch in 2024 LOS ALTOS, Calif., May 16, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.... Read More

LOS ALTOS, Calif., April 24, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, today announced that two datasets highlighting the safety and suggestive efficacy of UNI-494 in animal models were accepted for oral presentation at the upcoming 60 th European Renal Association Congress (ERA 2023) taking place... Read More

Closed transformational fundraise that included $30 million financing upfront with up to an additional $100 million tied to satisfaction of milestones Financing by new and existing institutional investors from high-profile healthcare-focused funds to support launch and commercialization of investigational new drug, Renazorb™ Company on track to file New Drug Application with the U.S. Food and Drug Administration in mid-2023... Read More

$30 million financing upfront with up to an additional $100 million tied to satisfaction of milestones Led by Vivo Capital with participation from RA Capital, BVF Partners, Logos Capital, and supported by existing investors Nantahala Capital Partners and Rosalind Advisors Inc. Vivo Capital’s Gaurav Aggarwal, MD to join the Board Company to implement mandatory dividend policy upon achievement of profitability LOS ALTOS,... Read More

Data from two abstracts supporting UNI-494’s potential to treat acute and chronic kidney injury accepted for presentation at the 28 th International Conference on Critical Care in Nephrology: the Acute Kidney Injury & CRRT 2023 Conference Highlights key role mitochondria play in disease progression in both acute and chronic kidney injury at 5 th Annual Chronic Kidney Disease Drug Development Summit LOS ALTOS, Calif., Feb.... Read More

Develops Renazorb opportunity in new market for patients with hyperphosphatemia Agreement includes upfront payment, royalties, and milestone payments LOS ALTOS, Calif., Feb. 02, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that it has entered into an exclusive license agreement with Lotus... Read More

LOS ALTOS, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that three abstracts have been accepted for presentation at the National Kidney Foundation’s (NFK) upcoming Spring Clinical Meetings taking place in Austin, Texas from April 11-15, 2023. The following data will be... Read More

LOS ALTOS, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that four abstracts have been accepted for presentation at the upcoming International Society of Nephrology’s World Congress of Nephrology 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023. The... Read More

LOS ALTOS, Calif., Dec. 29, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the termination of its “at-the-market” equity offering program (the “ATM Offering”) with JonesTrading Institutional Services, LLC as sales agent. The Company elected to terminate the ATM Offering to limit uncertainty and... Read More

Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol Renazorb’s enhanced product profile features reduced pill burden and small, swallowable tablets, which may improve patient compliance On track to file New Drug Application mid-2023 LOS ALTOS, Calif., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney... Read More

LOS ALTOS, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, announced today that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) has completed review of the Clinical Trial Application (CTA) and has issued a notice of acceptance for UNI-494 first-in-human... Read More