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]

Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $11.9 million, compared to a net loss of $15.2 million for the same period in 2024, indicating a reduction in losses [175]. - As of September 30, 2025, the company had an accumulated deficit of $113.2 million [175]. - Net loss for the nine months ended September 30, 2025, was $11.9 million, a decrease of $3.3 million, or 22%, compared to a net loss of $15.2 million in the same period of 2024 [200]. - The company expects to incur substantial additional losses in future periods and will require additional capital to complete clinical trials and product development initiatives [201]. Expenses - Research and development expenses decreased by approximately $81,000, or 3%, from $3.1 million in Q3 2024 to $3.0 million in Q3 2025 [188]. - General and administrative expenses increased by $1.2 million, or 37%, from approximately $3.2 million in Q3 2024 to approximately $4.4 million in Q3 2025 [189]. - Total operating expenses rose by $1.1 million, or 17%, from $6.3 million in Q3 2024 to $7.3 million in Q3 2025 [187]. - Research and development expenses decreased by approximately $7.9 million, or 53%, from $14.7 million in the nine months ended September 30, 2024, to $6.9 million in the same period of 2025 [192]. - General and administrative expenses increased by $7.3 million, or 90%, from $8.1 million in the nine months ended September 30, 2024, to $15.4 million in the same period of 2025 [193]. Cash Flow - Net cash used in operating activities was $23.3 million for the nine months ended September 30, 2025, compared to $22.0 million for the same period in 2024 [206][207]. - Net cash provided by financing activities was $39.9 million during the nine months ended September 30, 2025, compared to $44.7 million in the same period of 2024 [209]. Stock and Financing - The company sold 8,046,736 shares of common stock at an average price of $4.94 per share, resulting in net proceeds of approximately $38.6 million [179]. - The company sold 8,046,736 shares of common stock at an average price of $4.94 per share, resulting in net proceeds of approximately $38.6 million during the nine months ended September 30, 2025 [199]. - Future revenue streams may consist of collaboration or licensing revenue as well as product sales, with potential gross proceeds of up to $130.0 million from a securities purchase agreement [197]. Product Development - The company plans to resubmit the New Drug Application (NDA) for Oxylanthanum Carbonate by year-end 2025 following a Type A meeting with the FDA [180]. - The company is focused on developing Oxylanthanum Carbonate for hyperphosphatemia in chronic kidney disease patients and UNI-494 for acute kidney injury, addressing significant unmet medical needs [171][173]. - The healthcare costs associated with acute kidney injury exceed $9 billion annually in the U.S., highlighting the market potential for UNI-494 if approved [173]. - The company expects significant increases in operating expenses as it advances its product candidates through clinical development and regulatory approval [175]. Compliance and Reporting - The company is utilizing extended transition periods under the JOBS Act for compliance with new accounting standards, which may affect comparability with other public companies [217]. - As an "emerging growth company," the company plans to rely on certain exemptions, including not providing an auditor's attestation report on internal controls until certain revenue thresholds are met, specifically $1.235 billion [218]. - The company has no off-balance sheet arrangements during the reported periods [221]. - As a smaller reporting company, the company is not required to disclose quantitative and qualitative information about market risk [222]. Other Income - Other income increased by $2.8 million, or 36%, from a $7.7 million expense in the nine months ended September 30, 2024, to a $10.4 million income in the same period of 2025 [194].

Core Insights - Unicycive Therapeutics, Inc. is participating in the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025, where CEO Shalabh Gupta will engage in a fireside chat [1] - The company is focused on developing therapies for kidney diseases, with its lead investigational treatment, oxylanthanum carbonate, currently under FDA review for hyperphosphatemia in chronic kidney disease patients on dialysis [3] - Unicycive's second investigational treatment, UNI-494, is aimed at treating 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] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company specializing in novel treatments for kidney diseases [3] - The company is developing oxylanthanum carbonate as a phosphate binding agent and has completed a Phase 1 safety study for UNI-494 [3] - More information about the company can be found on its website and social media platforms [3]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Unicycive Therapeutics, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during the specified class period [2]. Group 1: Legal Investigation - The investigation is focused on long-term stockholders of Unicycive between March 29, 2024, and June 27, 2025, following a class action complaint filed on August 15, 2025 [2][4]. - Investors are encouraged to contact the law firm for discussions regarding their legal rights and options [1][4]. Group 2: Company Performance and Regulatory Issues - The complaint alleges that Unicycive misrepresented its readiness to meet FDA manufacturing compliance requirements for its New Drug Application (NDA) for oxylanthanum carbonate (OLC) [8]. - On June 10, 2025, Unicycive disclosed that the FDA identified deficiencies in current good manufacturing practice (cGMP) compliance at a third-party vendor, leading to a significant stock price drop of over 40% [8]. - Following the issuance of a Complete Response Letter from the FDA on June 30, 2025, citing the same deficiencies, Unicycive's stock fell nearly 30%, closing at $4.77 per share [8].

Core Insights - Unicycive Therapeutics is presenting new data on oxylanthanum carbonate (OLC) at the ASN Kidney Week 2025, highlighting significant reductions in pill burden for patients with chronic kidney disease (CKD) [1][2] Group 1: Study Findings - The open-label trial showed a 7-fold reduction in pill volume and a 2-fold reduction in pill count compared to pre-trial phosphate binder therapy [1][2] - The mean daily pill volume decreased from 9.3 cm to 1.4 cm, and the average number of pills taken daily dropped from 8.3 to 3.9 [6] - At the end of the OLC titration period, 91% of patients had serum phosphate levels ≤5.5 mg/dL, up from 59% at screening [6] Group 2: Product Information - OLC is an investigational oral phosphate binder utilizing proprietary nanoparticle technology, aimed at improving patient adherence by reducing the number and size of pills [8] - The company is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, supported by data from three clinical studies and a strong patent portfolio [9] Group 3: Industry 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 for phosphate control annually [10] - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [10]

Financial Position - As of September 30, 2025, Unicycive Therapeutics expects to report approximately $42 million in cash and cash equivalents[6] Regulatory Updates - The company received a Complete Response Letter from the U.S. FDA on June 30, 2025, regarding its New Drug Application for Oxylanthanum Carbonate[8] - An update on the timing of the resubmission of the New Drug Application was announced on October 28, 2025[8]