ATLANTA, June 30, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (NASDAQ: UNCY) complied with federal securities laws. On June 30, 2025, Unicycive “announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.” Following this news, the price of the Company’s stock dropped.  If you pur ...

Exhibit 99.1 Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update LOS ALTOS, California, May 14, 2025 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update. "We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC ...

--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 ...

Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025LOS 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. The Company's common stock is expected to begin trading on a split-adjusted basis when ...

- 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 Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in pa ...

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 ChatDate/Time: Thursday, May 29, 2025, at 12:30 p.m. ET Event: Noble Capital Markets 2025 Emerging Growth Virtual Equity Con ...

Investor Contacts: 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 Camino Real, Suite 210, Los Altos, CA 94022) will not change, but the ...

文章核心观点 - 公司公布2025年第一季度财务结果并进行业务更新，Oxylanthanum carbonate（OLC）新药申请正接受FDA审查，公司为其潜在获批和商业推出做准备，新数据凸显OLC市场潜力 [1] 财务结果 - 2025年第一季度研发费用220万美元，较2024年同期680万美元减少，主要因药物开发成本降低 [4] - 2025年第一季度一般及行政费用580万美元，较2024年同期240万美元增加，主要因商业推出准备相关咨询和专业服务增加 [5] - 截至2025年3月31日，预付费用和其他流动资产从2024年12月31日的480万美元增至760万美元，反映公司对商业供应制造的关注 [6] - 2025年第一季度其他收入860万美元，而2024年同期为费用1180万美元，主要因认股权证负债公允价值下降 [6] - 2025年第一季度归属于普通股股东的净收入为50万美元，2024年同期净亏损2120万美元，主要因认股权证负债公允价值下降 [7] - 截至2025年3月31日，现金及现金等价物共计1980万美元 [9] 业务进展 - OLC新药申请正接受FDA审查，PDUFA目标行动日期为2025年6月28日，公司正为潜在推出做准备，包括建立关键职能、与处方医生和其他利益相关者直接接触及支持市场准入 [8] - 通过在医学会议上发布数据和报告，提高OLC知名度及其满足慢性肾病患者重大需求的潜力 [8] - 与NKF合作的患者调查显示，200名透析患者认为过多药丸数量、大药丸尺寸和健忘是磷酸盐结合剂依从性的主要障碍，患者更倾向于药丸更少更小的药物方案 [8] - OLC关键2期研究的新患者报告结果数据显示，与试验前磷酸盐结合剂药物相比，患者更偏好OLC，且显著提高患者满意度 [8] 公司概况 - 公司是一家开发肾脏疾病新型疗法的生物技术公司，主要研究药物OLC正接受FDA审查，用于治疗慢性肾病透析患者的高磷血症，第二款研究药物UNI - 494用于治疗急性肾损伤相关病症，已获FDA孤儿药认定并完成健康志愿者1期剂量范围安全性研究 [10]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-40582 UNICYCIVE THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of (Prima ...

– 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 at the NKF Spring Clinical Meetings – LOS ALTOS, Calif., April 10, 2025 ( ...