Core Viewpoint - Unicycive Therapeutics, Inc. is actively participating in the biotech sector, focusing on developing therapies for kidney diseases, with significant upcoming events and investigational treatments under review [1][3]. Group 1: Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company dedicated to developing novel treatments for kidney diseases [3]. - The company's lead investigational treatment, oxylanthanum carbonate, is currently under review by the U.S. Food and Drug Administration (FDA) for treating hyperphosphatemia in patients with chronic kidney disease on dialysis [3]. - Unicycive's second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [3]. Group 2: Upcoming Events - Shalabh Gupta, M.D., the CEO of Unicycive, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026, at 1:30 p.m. ET [1]. - A live and archived webcast of the event will be available on the Unicycive website under the Investors section [2].

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FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027 LOS ALTOS, Calif., Jan. 29, 2026 (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 the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) ...

Unicycive Therapeutics (UNCY) announced on Thursday that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for its kidney disease therapy oxylanthanum carbonate (OLC). In late June, the FDA declined to approve the oral phosphate ...

Core Viewpoint - Unicycive Therapeutics has received FDA acceptance for the resubmission of its New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, with a target action date set for June 27, 2026 [1][9]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney diseases, with its lead investigational treatment being oxylanthanum carbonate [8]. - The company also has a second investigational treatment, UNI-494, which is intended for conditions related to acute kidney injury and has received orphan drug designation from the FDA [8]. Product Details - OLC is designed to reduce the number and size of pills required for treating hyperphosphatemia, potentially improving patient adherence compared to existing treatments [4]. - The NDA for OLC is supported by data from three clinical studies and various preclinical studies, with no concerns raised by the FDA regarding the safety or efficacy data [2]. Financial Position - As of the end of 2025, the company reported an unaudited cash position of $41.3 million, which is expected to support its commercial launch activities and provide a cash runway into 2027 [3][9]. Regulatory Pathway - Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, backed by a strong global patent portfolio that includes exclusivity until 2031, with potential extensions until 2035 [5]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease, with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [6].

Core Viewpoint - Unicycive Therapeutics has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, with a new PDUFA date expected in the first half of 2026, following progress in resolving compliance issues with its manufacturing vendor [1][2]. Group 1: Company Developments - The resubmission of the NDA was made possible due to significant progress by the original third-party manufacturing vendor in regaining FDA compliance [2]. - The company has a cash runway extending into 2027, positioning it well to complete the regulatory approval process for OLC [2]. - The NDA submission package includes data from three clinical studies and is supported by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [5]. Group 2: Product Information - OLC is an investigational oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology for enhanced phosphate binding potency [4]. - The treatment aims to reduce the pill burden for patients, potentially improving adherence compared to existing options [4]. Group 3: Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [6]. - Effective treatment of hyperphosphatemia is essential as uncontrolled levels are linked to increased mortality and hospitalization among CKD patients on dialysis [6].

Core Insights - Several biotechnology and pharmaceutical companies experienced significant gains in after-hours trading due to corporate updates and upcoming event announcements [1] Company Updates - Jasper Therapeutics, Inc. (JSPR) saw a 21.51% increase to $2.09 after hours, following the announcement of a webinar on December 2 to present findings from the BEACON study and preliminary data from the ETESIAN study [2] - NRx Pharmaceuticals, Inc. (NRXP) rose 13.39% to $2.71 after hours, with the CEO scheduled to present at NobleCon21 on December 3, discussing the company's expanded focus and clinical revenue progress [3] - Unicycive Therapeutics, Inc. (UNCY) increased by 5.42% to $6.33, with the CEO participating in two upcoming events, although no new announcements were made on Monday [4] - Spruce Biosciences, Inc. (SPRB) shares rose 4.68% to $87.00 after reporting a net loss of $8.2 million for the quarter ending September 30, 2025, an improvement from a net loss of $8.7 million in the previous year [5] - Evaxion A/S (EVAX) added 3.96% to $5.65, announcing progress in its CMV vaccine program with new protective data and ongoing preclinical development [6] - Solana Company (HSDT) gained 3.48% to $3.87, reporting a net loss of $352.8 million for the third quarter, a significant increase from a net loss of $3.7 million in the prior-year period, with revenue totaling $697,000 [7] - Protara Therapeutics, Inc. (TARA) rose 5.04% to $7.08, planning a conference call on December 3 to review interim data from its Phase 2 trial of TARA-002 in bladder cancer patients [8]

Core Viewpoint - Grabar Law Office is investigating claims on behalf of shareholders of Unicycive Therapeutics, Inc. regarding potential breaches of fiduciary duties by certain officers and directors of the company [1]. Group 1: Investigation Details - The investigation focuses on whether certain officers and directors of Unicycive Therapeutics breached their fiduciary duties to the company [1]. - Shareholders who purchased Unicycive shares prior to March 29, 2024, and still hold them can seek corporate reforms and the return of funds to the company at no cost [2][4]. Group 2: Allegations of Misconduct - A federal securities fraud class action complaint alleges that Unicycive's officers made false statements regarding the company's readiness to meet FDA manufacturing compliance requirements and overstated the regulatory prospects of the oxylanthanum carbonate new drug application [3]. - The public statements made by the defendants were claimed to be materially false and misleading at all relevant times [3].

Core Insights - Unicycive Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for kidney disease [1][2] - The company will participate in two investor events in December 2025, including the Piper Sandler 37th Annual Healthcare Conference and a Noble Capital Markets Virtual Presentation [1] Company Overview - Unicycive's lead investigational treatment is oxylanthanum carbonate, a phosphate binding agent under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [2] - The second investigational treatment, UNI-494, targets conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [2] - UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers [2]

Core Insights - Unicycive Therapeutics is advancing its lead investigational treatment, oxylanthanum carbonate (OLC), for patients with hyperphosphatemia and plans to resubmit the New Drug Application (NDA) by the end of 2025 following positive discussions with the FDA [2][8] - The company reported a net loss of $6.0 million for the quarter ended September 30, 2025, an increase from a net loss of $4.1 million in the same period of 2024, primarily due to increased labor and professional services costs [6][9] - Unicycive ended Q3 2025 with $42.7 million in cash, providing a runway into 2027, which positions the company well for regulatory approval and potential product launch [7][9] Financial Results - Research and Development (R&D) expenses for Q3 2025 were $3.0 million, a slight decrease from approximately $3.1 million in Q3 2024, attributed to reduced professional services and drug development costs [4] - General and Administrative (G&A) expenses increased to $4.4 million in Q3 2025 from $3.2 million in Q3 2024, mainly due to higher labor and consulting costs [5] - Other income decreased to $1.3 million in Q3 2025 from $2.2 million in Q3 2024, primarily due to changes in the fair value of warrant liability [6] Upcoming Milestones - The company is on track to resubmit the NDA for OLC by year-end 2025, with a potential new Prescription Drug User Fee Act (PDUFA) date in the first half of 2026 [8] - New data presented at the ASN Kidney Week 2025 indicates that OLC significantly reduces pill burden, with a 7-fold decrease in pill volume and a 2-fold reduction in pill count compared to existing phosphate binders [2][8]