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]

Core Insights - Reviva Pharmaceuticals is advancing its brilaroxazine program towards potential registration, with a planned meeting with the FDA in Q4 2025 to discuss the New Drug Application (NDA) submission targeted for Q2 2026 [2][5] Clinical Program and Business Highlights - The company successfully completed a 1-year open-label extension (OLE) trial for brilaroxazine, demonstrating a well-tolerated safety profile and robust broad-spectrum efficacy across all symptom domains in schizophrenia [1][5] - Brilaroxazine showed a significant reduction in PANSS total score by 18.1, positive symptoms by 5.0, and negative symptoms by 4.4, with a discontinuation rate of 35% after 1 year [5] - Reviva is expanding its patent portfolio, aiming for potential patent and market exclusivity up to 2045 and beyond [5] - A late-breaking poster presentation on the RECOVER 12-month OLE trial was presented at the 2025 ASCP annual meeting [5] Financial Results - For the second quarter ended June 30, 2025, the company reported a net loss of approximately $6.1 million, or $0.12 per share, compared to a net loss of approximately $7.9 million, or $0.26 per share, for the same period in 2024 [10][13] - As of June 30, 2025, cash and cash equivalents totaled approximately $10.4 million, down from approximately $13.5 million as of December 31, 2024 [10][11] Anticipated Milestones and Events - The company plans to initiate a potential registrational Phase 3 RECOVER-2 trial for brilaroxazine pending FDA recommendations [5] - An IND submission for a liposomal-gel formulation of brilaroxazine in psoriasis is expected by Q2 2026 [10]

Core Insights - Nicox SA has announced the completion of the last patient visit in the Denali Phase 3 clinical trial for NCX 470, a treatment for open-angle glaucoma and ocular hypertension [1][3] - The trial enrolled a total of 696 patients, with topline results expected between mid-August and mid-September 2025 [2][6] - NCX 470 is a novel NO-donating bimatoprost eye drop aimed at lowering intraocular pressure, and the trial compares its efficacy to latanoprost [3][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health [5][7] - The company is headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris [8] Future Milestones - Topline results from the Denali trial are anticipated in mid-August to mid-September 2025 [6] - A New Drug Application (NDA) submission for NCX 470 in the U.S. is targeted for the first half of 2026, contingent on securing a U.S. partner or necessary funding [5][6] - Initiation of NCX 470 Phase 3 clinical trials in Japan is expected in the second half of 2025 [6]

Core Viewpoint - The FDA has identified deficiencies in cGMP compliance at a third-party manufacturing vendor for Unicycive Therapeutics' New Drug Application (NDA) for oxylanthanum carbonate (OLC), with a final decision expected by June 28, 2025 [1][2]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being oxylanthanum carbonate (OLC) [6]. - OLC is an oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology to enhance phosphate binding potency [3][4]. Product Details - OLC aims to reduce the pill burden for patients, potentially improving adherence compared to existing treatments [3]. - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting the product until at least 2031, with potential extensions until 2035 [4]. 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 [5]. - Effective treatment of hyperphosphatemia is essential to reduce associated risks of increased mortality and hospitalization in CKD patients on dialysis [5].

Core Insights - Reviva Pharmaceuticals is advancing its late-stage brilaroxazine program towards registration, with significant upcoming milestones including the full dataset from the long-term open-label extension trial expected in Q2 2025 and the initiation of the Phase 3 RECOVER-2 trial anticipated in mid-2025 [2][4]. Clinical Program Highlights - A total of 446 participants completed the long-term open-label extension trial for brilaroxazine, with 156 completing one year and 301 completing six months of treatment [1][5]. - The full data analysis from the RECOVER OLE trial will include clinical response, safety, efficacy, adherence, and biomarker data, expected to be reported in Q2 2025 [1][5]. - The company plans to submit a New Drug Application (NDA) for brilaroxazine in the fourth quarter of 2026, targeting unmet needs in schizophrenia treatment [2][5]. Financial Results - For the first quarter ended March 31, 2025, the company reported a net loss of approximately $6.4 million, or $0.13 per share, compared to a net loss of approximately $7.4 million, or $0.25 per share, for the same period in 2024 [10][12]. - As of March 31, 2025, cash and cash equivalents totaled approximately $5.3 million, down from approximately $13.5 million as of December 31, 2024 [10][11]. Anticipated Milestones and Events - The company will present a late-breaking poster on the RECOVER 12-month OLE trial at the 2025 American Society of Clinical Psychopharmacology annual meeting on May 28, 2025 [5]. - The initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected in mid-2025, contingent on additional financing [5].

Core Viewpoint - XORTX Therapeutics Inc. is advancing its new drug application (NDA) for XORLO™, a proprietary formulation of oxypurinol aimed at treating gout, following guidance from the FDA on key steps necessary for the filing [2][4]. Company Developments - XORTX has received responses from the FDA clarifying the steps needed for the NDA submission for its XRx-026 program targeting gout [2][4]. - The company plans to finalize meeting minutes with the FDA, prepare an Investigational New Drug (IND) application, characterize pharmacokinetics, manufacture commercial supplies, and file the NDA [3][4]. - The NDA for XORLO™ is anticipated to be filed in the first half of 2026, emphasizing the company's commitment to addressing the unmet medical needs of gout patients [4]. Market Context - Approximately 44 million individuals in the US have elevated uric acid levels, with gout affecting about 9.2 million people, indicating a significant market opportunity for gout treatments [5]. - Current treatments include xanthine oxidase inhibitors (XOIs) like allopurinol, which is prescribed to around 3.3 million patients annually in North America, but some patients cannot tolerate it [6]. - XORLO™ aims to fill the gap left by existing treatments, particularly after the decline in the use of Febuxostat due to safety concerns [6].