UNCY - Earnings announcements

U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026Commercial readiness activities continue in anticipation of the potential commercial launch of OLC MOUNTAIN VIEW, Calif., May 12, 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 first quarter ended March 31, 2026, and provided a business update. "As we approach the June 29th PDUFA target action date, we remain opti

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

-   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

- 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

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

ORLANDO, FL / ACCESSWIRE / July 21, 2023 / RedChip Companies will air interviews with 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP) 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). Bloomberg TV is available in an estimated 73 million homes across the U.S.Access the interviews in their entirety at:60 Degrees Pharmaceuticals (NASDAQ:SXTP): https://www.redchip.com/assets/access/sxtp_accessUnicycive Therapeutics (NASDAQ:UNCY): https://www.redchip.com/assets/access/uncy_accessAbout The RedChip Money Report®The RedChip Money Report® is produced by RedChip Companies Inc., an international Investor Rela

ORLANDO, FL / ACCESSWIRE / June 9, 2023 / RedChip Companies will air new interviews with Unicycive Therapeutics, Inc. (NASDAQ:UNCY) and Alarum Technologies Ltd. (Nasdaq, TASE: ALAR) on The RedChip Money Report® on Bloomberg TV, this Saturday, June 10, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.Access the interviews in their entirety at:Unicycive Therapeutics, Inc. (NASDAQ:UNCY): https://uncyinfo.com/interview_accessAlarum Technologies Ltd.: https://alarinfo.com/interview_accessAbout The RedChip Money Report®The RedChip Money Report® is produced by RedChip Companies Inc., an international Investor Relations and media firm with 30 yea

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. (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 first quarter ended March 31, 2023 and provided a business update. "The first quart

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 with potential for approval and launch in 2024 LOS ALTOS, Calif., March 31, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY) (the "Company" or "Unicycive"), a clinical-stage biotechnology company developing therapies for patients with kidney disea

ORLANDO, FL / ACCESSWIRE / December 9, 2022 / RedChip Companies will air a new interview with Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, on The RedChip Money Report® on Bloomberg TV, this Saturday, December 10, at 7 p.m. Eastern Time (ET). Bloomberg TV is available in an estimated 73 million homes across the U.S.Interview highlights:In the exclusive RedChip Money Report interview, Unicycive's CEO Shalabh Gupta discusses the Company's lead program for hyperphosphatemia, expected data from the bioequivalence study, the upcoming Phase 1 trial, and much more.Access this interview in its entirety a

Topline results by year-end as enrollment completed for pivotal bioequivalence study of RENAZORB™ (lanthanum dioxycarbonate), an investigational phosphate binder for the treatment of hyperphosphatemia in Chronic Kidney Disease (CKD) patients on dialysis On track to file New Drug Application for RENAZORB in 2023 Expect clearance for a Phase 1 healthy volunteer study of UNI-494, a novel proprietary drug targeting the SUR2B subunit of the mitochondrial KATP channel, in the UK by year-end LOS ALTOS, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) --  Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announc

On track to file New Drug Application for Renazorb, the first proprietary nanoparticle-based phosphate binder for Chronic Kidney Disease (CKD) patients, by end of 2023 Signed first global partnership for rights to Renazorb in China with Lee's Pharmaceutical (HK) Ltd. to further advance global commercial strategy for product with a differentiated profile and ease of administration for CKD patients Expects to file regulatory submission to initiate a Phase 1 healthy volunteer study in 2H'22 with UNI-494, a novel proprietary drug targeting the SUR2 subunit of the mitochondrial KATP   channel activator LOS ALTOS, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (N

On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in second quarter 2022 Plans to initiate Phase 1 study for UNI-494 in second half of 2022 LOS ALTOS, Calif., May 12, 2022 (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 first quarter ended March 31, 2022 and provided a business update. Management Commentary "Throughout the first quarter, we continued to make meaningful progress to advance and expand the clinical development of our lead product candidates. We are on track

On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in first half of 2022 Plans to initiate Phase 1 study for UNI-494 in second half of 2022 LOS ALTOS, Calif., March 31, 2022 (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, 2021 and provided a business update. "The considerable progress we made throughout 2021 puts us in a strong position to execute on our strategy to advance our clinical development programs to address two important renal disease