Core Insights - REGENXBIO Inc. has completed enrollment in the pivotal AFFINITY DUCHENNE trial for RGX-202, a gene therapy for Duchenne muscular dystrophy, and has successfully produced initial batches for commercial supply [1][2][5] Trial Details - The AFFINITY DUCHENNE trial has enrolled 30 participants, focusing on the primary endpoint of achieving 10% microdystrophin expression at Week 12, with secondary endpoints assessing functional improvements [3][4] - In the Phase I/II portion, microdystrophin levels in participants ranged from 20% to 122%, with no serious adverse events reported, indicating a positive safety profile [4][8] Commercial Readiness - REGENXBIO has manufactured the first commercial supply batches of RGX-202, anticipating approval and launch in 2027, coinciding with market availability [5][6] - The company can produce up to 2,500 doses of RGX-202 annually using its proprietary NAVXpress manufacturing process, which achieves over 80% product purity [6][8] Product Overview - RGX-202 is positioned as a potential best-in-class gene therapy, utilizing a differentiated microdystrophin construct that encodes essential regions of dystrophin, including the C-Terminal domain [7][8] - Additional design features aim to enhance gene expression and reduce immunogenicity, supporting targeted delivery throughout skeletal and heart muscle [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]

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATESVancouver, British Columbia--(Newsfile Corp. - October 30, 2025) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical"), is pleased to announce that, further to its news releases of August 5, 2025, September 5, 2025 and October 10, 2025 it has closed a second tranche (the "Second Tranche") of its previously announced $1,200,000 non-brokered private placement (the " ...

Core Insights - Seres Therapeutics, Inc. will host a conference call on November 5, 2025, at 8:30 a.m. ET to discuss Q3 2025 financial results and business updates [1][2] Company Overview - Seres Therapeutics is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [3] - The company developed VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3] - Seres is developing SER-155, which has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing infection risk and graft-versus-host disease in the same patient group [3] - SER-155 demonstrated a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study [3] - The company plans to evaluate SER-155 and other cultivated live biotherapeutic candidates in various medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, and solid organ transplant recipients [3]

Core Insights - NLS Pharmaceutics and Aexon Labs announced the expansion of their DOXA platform with the AEX-6xx series, focusing on small molecules that target arousal stability, cognition, and neuroprotection [1][4] - AEX-635, a lead compound, modulates MRP1, enhancing neuroprotective effects and improving CNS drug bioavailability, particularly in conditions like Parkinson's disease [1][3] Platform Expansion - The AEX-6xx program broadens the translational scope of the DOXA platform, integrating dual orexin receptor agonism with cathepsin H inhibition to address sleep-wake regulation and neuronal resilience [3][4] - The DOXA series aligns with the mission of NewCelX, the combined entity of NLS and Kadimastem, to innovate in neuroscience and cell therapy for neurological and metabolic disorders [4] Financial Position - NLS raised approximately $7 million in equity financing and secured a $25 million equity line of credit, strengthening its cash position for upcoming operations [5][6] - The financing is expected to support clinical programs and ensure the company is well-capitalized for at least the next 12 months [5] Preclinical Highlights - The DOXA platform shows up to 80% reduction in cataplexy and over 70% increase in wakefulness in narcolepsy models, demonstrating sustained efficacy without orexin receptor desensitization [9] - The platform exhibits robust neuroprotective activity under stress conditions, with potential applications in Type 1 Narcolepsy, ADHD, and neurodegenerative diseases [9][10] Intellectual Property - The AEX-6xx series is protected under international patent applications, advancing through national phases in key markets including the US, EU, and Japan [11] Strategic Next Steps - NLS and Aexon Labs are preparing for preclinical partnering discussions and plan to launch a unified brand identity under NewCelX, emphasizing their cross-continental model [12]

Core Points - Evommune, Inc. has filed a registration statement for an initial public offering (IPO) of its common stock, offering 9,375,000 shares at an expected price between $15.00 and $17.00 per share [1] - The company plans to grant underwriters a 30-day option to purchase an additional 1,406,250 shares in connection with the IPO [1] - Evommune's common stock is expected to be listed on the New York Stock Exchange under the symbol "EVMN" [1] - The registration statement is anticipated to become effective on November 5, 2025, allowing the company to price the offering shortly thereafter [1] - Morgan Stanley, Leerink Partners, Evercore ISI, and Cantor are acting as joint book-running managers for the proposed offering [2] Company Overview - Evommune, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies targeting chronic inflammatory diseases [5] - The company's mission is to enhance patients' daily lives and mitigate long-term effects of uncontrolled inflammation caused by existing therapy limitations [5] - Evommune is advancing a portfolio of differentiated product candidates aimed at addressing key drivers of chronic inflammation [5]

Biogen cut its annual profit forecast on Thursday, as it expects to take a hit of $1.25 per share from R&D related charges tied to certain acquisitions in the fourth quarter. ...

Financial Performance - Alphabet Inc. reported third-quarter revenue of $102.35 billion, exceeding analyst estimates of $99.64 billion [1] - The company achieved earnings of $2.87 per share, surpassing expectations of $2.33 per share [1] Market Reaction - Shares of Alphabet rose 7.8% to $296.11 in pre-market trading following the earnings report [2] Other Notable Stocks - VCI Global Limited gained 110% to $3.78 after announcing plans to launch the XVIQ token [5] - Cambium Networks Corporation surged 87.8% to $5.54 after integrating its network solution with Starlink [5] - Guardant Health, Inc. rose 22.3% to $88.45 after reporting better-than-expected financial results and raising FY25 sales guidance [5] - FMC Corporation fell 27.3% to $21.10 after reporting a $510 million write-down and announcing a dividend cut [5][7]

Core Insights - The core focus of the news is on the strategic collaboration between Innovent Biologics and JD Health, highlighting Innovent's product pipeline and growth targets, particularly in the area of weight management drugs [1][3][4]. Company Overview - Innovent Biologics has 16 products on the market, making it the Chinese company with the most marketed monoclonal antibody products. The company has benefited 5 million patients and has 21 clinical pipelines with 140,000 liters of operational capacity [1]. - The company aims to commercialize 17 products by 2025 and achieve positive EBITDA, with a target of 20 commercialized products and revenue of 20 billion RMB by 2027 [1]. Product Development - Innovent's weight management drug, the first global GCG/GLP-1 dual receptor agonist, was approved for market in June 2023, marking a significant milestone in the company's innovation efforts [1][3]. - The drug, named "信尔美" (Masitide), was launched on JD Health's platform shortly after approval, attracting over 30,000 users in the first month and achieving over 1 million searches on JD's platform within a month [3]. Strategic Collaboration - The partnership with JD Health leverages three core advantages: strong supply chain capabilities, a large user base, and digital marketing expertise [4]. - JD Health's logistics management ensures safe and compliant delivery of temperature-sensitive medications, with nationwide cold chain storage capabilities [4][5]. Market Reach and Services - JD Health has launched an online "Weight Management Clinic" to address various health needs related to weight issues, integrating multidisciplinary resources including top-tier doctors and nutritionists [5]. - The platform has over 10,000 online pharmacists and an AI pharmacist named "Xiao Fang," providing 24/7 medication guidance and enhancing patient adherence to medication [5]. Logistics and Delivery - JD Logistics has invested in specialized cold chain equipment to ensure the safe transport of medications, maintaining a temperature range of 2-8°C for up to 72 hours [6]. - The company has established 33 drug warehouses nationwide, ensuring over 90% of orders can be delivered on the same or next day, with rapid delivery options for temperature-sensitive drugs [5][6].

Core Insights - BioNxt Solutions Inc. has received a "Readiness to Grant" notification from the Eurasian Patent Organization for its patent application related to sublingual delivery of anticancer drugs targeting autoimmune neurodegenerative diseases [1] - The patent family opens up various proprietary product development and commercialization opportunities for the company [1] - BioNxt's lead product, BNT23001, is a sublingual thin-film formulation of Cladribine aimed at treating multiple sclerosis [1]