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Corbus Pharmaceuticals Reports Results from Phase 1a Study of Oral CB1 Inverse Agonist CRB-913 for the Treatment for Obesity Demonstrating Favorable Safety Profile and Emerging Evidence of Weight Loss
Globenewswire· 2025-12-11 12:00
CRB-913 was safe and well-tolerated across all doses studiedDaily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participantsA placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12)A 12-week dose-finding study in people with obesity initiated with completion expected in summer 2026Company to host conference call and live webcast today at 8:00 am ET NORWOOD, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmace ...
Rezolute Announces Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism
Globenewswire· 2025-12-11 12:00
Core Insights - The Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism did not meet its primary or key secondary endpoints, showing a 45% reduction in hypoglycemia events at the highest dose compared to a 40% improvement in the placebo group, which was not statistically significant [1][2] - The study involved 63 participants across multiple countries and aimed to evaluate the efficacy and safety of ersodetug in patients experiencing hypoglycemia despite standard care [8] Study Results - The primary endpoint assessed the change in average weekly hypoglycemia events, which did not show significant improvement with ersodetug compared to placebo [2] - The key secondary endpoint, measuring average daily percent time in hypoglycemia, also did not demonstrate significant results, with a 25% reduction in time in hypoglycemia for the 10 mg/kg dose versus a 5% increase in the placebo group [2] - Dosing regimens included 5 and 10 mg/kg administered every other week for three doses, followed by every four weeks for the remaining 24-week treatment duration, achieving target drug concentrations across all age groups [3] Safety Observations - Safety data from the study were generally favorable, supporting the safe use of ersodetug in both pediatric and adult patients [4] - Two participants experienced serious hypersensitivity reactions leading to early discontinuation, but the incidence of serious allergic reactions was low compared to other biologic treatments [4] - The most common adverse event reported was hypertrichosis, which was mild and self-limiting [4] Company Statements and Future Plans - The company expressed disappointment over the study results but indicated that certain aspects warrant further investigation and a thorough evaluation to understand the outcomes better [5] - The company plans to meet with the FDA under the Breakthrough Therapy Designation to discuss next steps for the program [5] - An ongoing Phase 3 study for tumor hyperinsulinism (upLIFT) is expected to release topline results in the second half of 2026 [5] About Ersodetug - Ersodetug is a fully human monoclonal antibody designed to decrease insulin receptor over-activation, potentially treating hypoglycemia from any form of congenital or acquired hyperinsulinism [9] - The company focuses on rare diseases, particularly hypoglycemia caused by hyperinsulinism, and aims to provide meaningful treatment options for affected patients [10]
Kymera Therapeutics Announces U.S. FDA Fast Track Designation for KT-621, a First-in-Class, Oral STAT6 Degrader for the Treatment of Atopic Dermatitis
Globenewswire· 2025-12-11 12:00
Core Insights - The FDA has granted Fast Track designation to KT-621, a first-in-class oral STAT6 degrader for treating moderate to severe atopic dermatitis (AD) [1][2][3] - KT-621 aims to provide a once-daily oral treatment option that matches the efficacy and safety of injectable biologics, addressing significant gaps in current treatment options for AD and other Type 2-driven diseases [2][4] - Positive results from the BroADen Phase 1b trial indicate KT-621's potential in treating Type 2 inflammatory diseases, with ongoing Phase 2b trials expected to yield data by mid-2027 [1][2][4] Company Overview - Kymera Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral small molecule degrader medicines for immunological diseases [1][6] - The company has advanced the first degrader into clinical evaluation for immunological diseases and aims to build a leading pipeline of therapies [6] - Founded in 2016, Kymera has been recognized as one of Boston's top workplaces [6] Atopic Dermatitis Context - Atopic dermatitis is a chronic inflammatory disease that significantly impacts patients' quality of life, with a notable unmet need for improved treatment options [5] - Current treatments include topical therapies and injectable biologics, but many patients remain untreated [5]
Cibus Welcomes the Positive Conclusion of Trilogue Negotiations on New Genomic Techniques Legislation Between the European Parliament and Council
Globenewswire· 2025-12-11 12:00
Core Viewpoint - The European Union has reached a political agreement on New Genomic Techniques (NGTs), including gene editing, which supports Cibus' plans to enhance plant traits for European growers [1][2][3] Regulatory Framework - The agreed legislative text provides a framework for the development and cultivation of gene-edited plants, addressing intellectual property and seed access [2][4] - This agreement is a significant step towards the formal endorsement of NGT legislation by the European Parliament and Council [2][4] Industry Impact - The agreement signifies the EU's commitment to gene editing technology, facilitating the development of improved plant varieties for the European market [3][6] - Cibus anticipates that this regulatory clarity will enhance opportunities for developing traits in the European market, leveraging successful field trials conducted in the UK [5][6] Product Pipeline - Cibus' product pipeline includes programs aimed at addressing agricultural challenges such as disease resistance and nitrogen use efficiency, which are well-positioned to benefit European growers [7][8] - The company focuses on developing high-value traits for major global row crops, utilizing proprietary gene editing technology to expedite the breeding process [8]
Nevada Lithium Announces Winter Work Program Focused on Further Enhancing Value of the Bonnie Claire Lithium & Boron Project
Globenewswire· 2025-12-11 12:00
Core Viewpoint - Nevada Lithium Resources Inc. has initiated a winter work program at its 100% owned Bonnie Claire lithium project to address questions from the 2025 Preliminary Economic Assessment (PEA) and evaluate the potential for additional critical mineral recovery, particularly cesium and rubidium, alongside lithium and boron [1][2][5]. Group 1: Project Development - The company is progressing with several recommendations from its PEA to establish a foundation for a larger work program in 2026 aimed at advancing the project towards a Pre-Feasibility Study [5]. - The CEO highlighted the multi-faceted nature of the work program, which is expected to yield valuable technical information with positive economic implications [2]. Group 2: Mineral Recovery Potential - Significant cesium (Cs) and rubidium (Rb) mineralization has been identified at Bonnie Claire, with initial tests indicating their presence in the pregnant leach solution (PLS) [6][7]. - A proof-of-concept study has been commissioned to evaluate the recovery potential of cesium and rubidium, which could enhance the project's economic viability [7][8]. Group 3: Technical Due Diligence - The company is conducting due diligence on the Hydraulic Borehole Mining Method (HBHM) to validate its suitability for extracting high-grade lithium and boron at Bonnie Claire [3][9]. - A global engineering firm has been retained to review the mine design and geotechnical conditions, ensuring the HBHM method is applicable to the geology of Bonnie Claire [11][12]. Group 4: Lithium Residency Research - The company has signed a research agreement with the University of Naples Federico II to investigate lithium distribution in clay minerals at Bonnie Claire [14]. - The research will utilize advanced techniques such as X-ray diffraction and Scanning Electron Microscopy to analyze ore textures and mineralogy, aiming to improve resource modeling [15][16]. Group 5: Economic Assessment - The 2025 PEA indicates a $6.829 billion after-tax net present value at an 8% discount rate, based on lithium carbonate priced at $24,000 per tonne and boric acid at $950 per tonne, with a projected after-tax internal rate of return of 32.3% [19].
Opus Genetics to Present at the J.P. Morgan 2026 Healthcare Conference
Globenewswire· 2025-12-11 12:00
Core Insights - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies aimed at restoring vision and preventing blindness in patients with inherited retinal diseases [3] Company Overview - The company is developing durable, one-time treatments that target the underlying genetic causes of severe retinal disorders [3] - Opus Genetics has a pipeline that includes seven AAV-based programs, with key candidates such as OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration [3] - Additional candidates in development target RHO, RDH12, and MERTK mutations [3] - The company is also advancing Phentolamine Ophthalmic Solution 0.75%, which is an approved therapy for pharmacologically induced mydriasis, with further indications in late-stage development for presbyopia and low-light visual disturbances following keratorefractive surgery [3] - Opus Genetics is headquartered in Research Triangle Park, NC [3] Upcoming Events - George Magrath, M.D., the CEO of Opus Genetics, will present at the J.P. Morgan 2026 Healthcare Conference on January 15, 2026, at 8:15 a.m. PT [1]
YSX TECH. CO., LTD Relocates Research and Development Center to Expanded Facility
Globenewswire· 2025-12-11 12:00
GUANGZHOU, China, Dec. 11, 2025 (GLOBE NEWSWIRE) -- YSX TECH. CO., LTD (NASDAQ: “YSXT”) (the “Company”), a Cayman Islands exempted company that, through its variable interest entities in China, provides comprehensive business solutions mainly for insurance companies and brokerages in China, today announced that the Company has relocated its research and development center (the “R&D Center”) to a new expanded location at Building 9, East Zone, Times Fangzhou, No. 2 Huazhou Road, Haizhu District, Guangzhou, C ...
Immatics Presents IMA203CD8 PRAME Cell Therapy Data from Ongoing Dose Escalation and Shows Promising Initial Anti-tumor Activity in PRAME-Positive Tumors at ESMO-IO 2025 Congress
Globenewswire· 2025-12-11 12:00
Core Insights - Immatics N.V. announced updated Phase 1a dose escalation data for its second-generation PRAME cell therapy, IMA203CD8, targeting difficult-to-treat solid tumors expressing PRAME, including ovarian cancer [1][3][4] Patient Population - The ongoing Phase 1a trial enrolled 78 heavily pre-treated patients with advanced solid tumors expressing PRAME, with a median of three prior systemic treatments [4] - The efficacy-evaluable population included 69 patients, comprising 42 with melanoma, 11 with ovarian carcinoma, 11 with synovial sarcoma, and 5 with other tumor types [4] Safety Profile - IMA203CD8 demonstrated manageable tolerability, with the most common treatment-emergent adverse events being cytopenias associated with lymphodepletion [5][7] - Cytokine release syndrome (CRS) was mostly Grade 1 to 2, with Grade 1 at 35%, Grade 2 at 50%, Grade 3 at 9%, and Grade 4 at 1% [5] Anti-Tumor Activity - Initial results showed deep and durable objective responses in PRAME-positive advanced solid tumors, with a one-time infusion of IMA203CD8 leading to a 36% confirmed objective response rate (cORR) and a 46% overall response rate (ORR) [10][12] - In patients with ovarian carcinoma, a promising dose-dependent signal was observed, with two confirmed partial responses and one ongoing metabolic complete response at the highest dose level [11] Clinical Development - The company aims to complete the Phase 1a dose escalation and determine the recommended Phase 2 dose (RP2D) by 2026, including data on the two highest dose levels [15] - IMA203CD8 is positioned to target advanced PRAME cancers beyond melanoma, starting with gynecologic cancers, and may not require post-infusion low-dose IL-2 in the future [14][16] Company Overview - Immatics is a leader in precision targeting of PRAME, with a broad franchise that includes multiple product candidates and therapeutic modalities targeting PRAME across various cancers [17][18]
Asante Provides Financial and Operating Results for the Quarter Ended October 31, 2025
Globenewswire· 2025-12-11 12:00
Core Viewpoint - Asante Gold Corporation reported challenges in gold production due to equipment mobilization issues at its Bibiani and Chirano mines, but anticipates improvements in Q4 2025 with new initiatives in place to enhance production levels [1][2][3]. Financial Performance - Revenue for Q3 2026 was $129.3 million, a 16% increase from $111.1 million in Q3 2025, primarily driven by a higher average gold price of $3,594 per ounce compared to $2,552 per ounce in the same period last year [10]. - Total comprehensive loss for Q3 2026 was $(215.2) million, compared to $(15.5) million in Q3 2025 [8]. - Adjusted EBITDA for Q3 2026 was $(6.4) million, down from $17.6 million in Q3 2025, reflecting lower gold sales and higher production costs [11]. Production and Operations - Gold equivalent production for Q3 2026 was 37,333 ounces, down from 45,273 ounces in Q3 2025, with gold sold decreasing to 35,982 ounces from 43,551 ounces [12][21]. - The all-in sustaining cost (AISC) increased to $4,574 per ounce in Q3 2026, compared to $2,347 per ounce in Q3 2025, driven by increased stripping requirements and lower grade ore processed [13][22]. Mine-Specific Updates Bibiani Mine - Material movement increased significantly, with total material mined up 318% in Q3 2026 compared to Q3 2025, marking the highest quarterly material mined in three years [16]. - The stripping ratio at Bibiani was approximately 49.4 in Q3 2026, compared to 16.1 in Q3 2025, indicating increased waste removal [14]. - Gold recovery rates improved from 60% to approximately 90% following the operation of the oxygen plant [3]. Chirano Mine - Ore processed increased by 15.3% in Q3 2026 compared to Q3 2025, attributed to stable power availability and plant throughput improvements [32]. - AISC for Chirano increased to $2,964 per ounce in Q3 2026 from $2,031 in Q3 2025, primarily due to lower gold production [34]. Strategic Initiatives - The company plans to enhance production capabilities at both mines, including the full mobilization of equipment and the construction of a road connecting Bibiani to Chirano, expected to be completed by Q2 2026 [23]. - Asante aims to produce between 215,000 and 245,000 ounces of gold at Bibiani in 2026, with a target of achieving annual consolidated gold production of approximately 500,000 ounces by 2028 [24][35]. Management Changes - Asante appointed Patrick Padmore as Vice President of Finance, bringing over 17 years of experience in the resource sector [37].
EVgo Announces Chief Financial Officer Transition
Globenewswire· 2025-12-11 12:00
Core Viewpoint - EVgo has appointed Keefer Lehner as Chief Financial Officer effective January 12, 2026, to support its growth in the electric vehicle charging sector and has reiterated its financial guidance for 2025 [2][4][5]. Leadership Transition - Keefer Lehner will succeed Paul Dobson, who is retiring but will remain in an advisory role until March 2026 to ensure a smooth transition [2][4]. - Lehner brings nearly 20 years of experience in finance and operations, having previously served as CFO at KLX Energy Services and co-founded Quintana Energy Services [3][9]. Strategic Importance - The appointment of Lehner is seen as crucial for EVgo as it aims to accelerate the nationwide buildout of its EV charging infrastructure [4]. - CEO Badar Khan emphasized Lehner's experience in scaling businesses and his commitment to advancing EVgo's strategic priorities [4]. Financial Guidance for 2025 - EVgo has reiterated its financial guidance for 2025, projecting total revenue between $350 million and $365 million, with potential ancillary upside of up to $40 million, bringing the total possible revenue to $405 million [5][6]. - The company expects an Adjusted EBITDA loss between $(15) million and $(8) million, with potential ancillary upside of up to $31 million, resulting in a possible loss range of $(15) million to $(23) million [6]. Company Overview - EVgo is one of the largest public fast charging networks for electric vehicles in the U.S., operating over 1,100 fast charging stations across 47 states [10]. - The company partners with various businesses to deploy accessible charging infrastructure and conducts interoperability testing at its Innovation Lab [10].