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Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area
Globenewswire· 2025-11-24 10:30
Core Viewpoint - Alvotech has received approval from the European Commission for AVT03 as a biosimilar to Prolia and Xgeva, which is expected to enhance access to treatments for osteoporosis and cancer-related skeletal issues in Europe [1][4][5]. Company Summary - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space by providing high-quality, cost-effective products [11]. - The approval of AVT03 reflects Alvotech's strong end-to-end platform and its commitment to delivering affordable medicines to patients [4][5]. - Alvotech has established strategic partnerships for the commercialization of AVT03 in Europe, collaborating with STADA and Dr. Reddy's, each holding semi-exclusive rights in various regions [7][12]. Product Summary - AVT03 is approved in two forms: as a 60 mg/mL single-use pre-filled syringe for osteoporosis treatment and as a 70 mg/mL single-use vial for preventing skeletal-related events in cancer patients [3][9]. - The European denosumab market is valued at approximately US$1.2 billion, indicating a significant opportunity for AVT03 to capture market share [2]. - The approval was based on comprehensive evidence, including pharmacokinetic and pharmacodynamic data, and clinical studies demonstrating equivalent efficacy and safety compared to the reference products [8]. Market Context - Osteoporosis-related disabilities in Europe surpass those caused by common cancers, highlighting the importance of effective treatments [6]. - The economic burden of fragility fractures in Europe was estimated at €57 billion in 2019, underscoring the need for cost-effective treatment options like biosimilars [6][7].
OVHcloud and LCH SA sign cloud agreement
Globenewswire· 2025-11-24 10:10
Core Insights - OVHcloud has signed a cloud hosting agreement with LCH SA to enhance operational resilience, security, scalability, and faster deployment of services [1][2] - The migration of LCH SA's services to a SecNumCloud qualified environment marks a significant step in its digital transformation [2] - OVHcloud's SecNumCloud solution allows LCH SA to utilize advanced cloud technology while ensuring high security and regulatory compliance [3] Company Overview - OVHcloud is recognized as a global cloud player and the leader in the European cloud market [1] - LCH SA is a key provider of market infrastructure in Europe and plays a significant role in the global financial community [3] Strategic Implications - The collaboration supports LCH SA's fast-growing, diversified global activities across various asset classes [2] - The use of OVHcloud's services is expected to enhance operational efficiency and scalability for LCH SA [3]
Lotus Technology Reports Unaudited Third Quarter and First Nine Months 2025 Financial Results
Globenewswire· 2025-11-24 10:00
Core Insights - Lotus Technology Inc. reported its unaudited financial results for Q3 and the first nine months of 2025, highlighting a challenging transitional period impacted by tariffs and inventory adjustments [1][2][3] Operating Highlights - Total deliveries for the first nine months of 2025 reached 4,612 units, a significant decrease of 40% compared to 7,673 units in the same period of 2024 [5] - Deliveries were primarily driven by China and Europe, with China outpacing the premium auto segment, indicating strong competitive positioning [3][6] - The gross margin improved to 8% in Q3 2025, up from 3% in Q3 2024, attributed to a higher share of upgraded models in total deliveries [3][15] Financial Performance - Total revenue for the first nine months of 2025 was $356 million, down 46% from $653 million in the same period of 2024 [9] - The net loss narrowed by approximately 68% in Q3 and 43% for the nine-month period, indicating improved financial health [8][13] - Key financial results for Q3 2025 included revenue of $137 million, a 46% decrease year-over-year, and a net loss of $65 million, a 68% reduction from the previous year [20][15] Model and Regional Deliveries - Deliveries by model type showed a decline in both Lifestyle SUVs and Sedans (down 18%) and Sportscars (down 64%) compared to the previous year [5] - Regional delivery breakdown indicated that China accounted for 46% of total deliveries, while Europe contributed 34% [6] Strategic Developments - The company plans to unveil a new PHEV model soon, which will enhance its electrification strategy and cater to diverse consumer demands [4][11] - The strategic acquisition of Lotus UK is progressing, expected to close in 2026, aimed at integrating operations and enhancing efficiency [6][11]
The 5th International New Materials Industry Conference kicks off in Bengbu
Globenewswire· 2025-11-24 09:21
Core Insights - The 5th International New Materials Industry Conference commenced in Bengbu, Anhui Province, focusing on "New Technology, New Materials, New Future" [1] - The event attracted over 400 participants, including academicians, experts, and industry leaders [1] Group 1: Government and Institutional Support - Congratulatory letters were sent by Liang Yanshun, Secretary of the CPC Anhui Provincial Committee, and Wang Qingxian, Governor of Anhui Province [2] - The opening ceremony featured speeches from notable figures, including Zhou Yuxian, Chairman of China National Building Material Group, and academicians Gan Yong and Jiang Desheng [2] Group 2: Industry Development and Investment - Anhui Province aims to nurture new quality productive forces, with an annual industrial output target of one trillion CNY [3] - During the conference, 162 projects were signed with a total investment of 70.197 billion CNY, including 79 projects worth 25.101 billion CNY to be implemented in Bengbu [3] - The conference included activities focused on "investment promotion and talent introduction," contributing to industrial upgrading [3]
BioPorto A/S raises approximately DKK 43 million in new capital round - Change in number of shares and votes
Globenewswire· 2025-11-24 09:09
Core Points - BioPorto A/S has completed a private placement of 40,438,426 new shares, raising approximately DKK 43 million in new capital [1][2] - The new shares represent 8.89% of BioPorto's registered share capital prior to the increase [2] - The nominal share capital of BioPorto now amounts to DKK 495,108,887, consisting of 495,108,887 shares [4] Company Overview - BioPorto is an in vitro diagnostics company focused on improving patient outcomes through actionable kidney biomarkers, particularly for Acute Kidney Injury (AKI) [5] - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and management of AKI, enabling earlier intervention [5] - BioPorto's tests are marketed under various registrations, including CE mark in several countries and FDA clearance for ProNephro AKI™ in the US [5] Trading and Listing - The new shares will be admitted to trading and officially listed on Nasdaq Copenhagen A/S under the company's permanent ISIN code [3] - The new shares carry the same rights as existing shares, including the right to receive dividends from the time the capital increase is registered [3] Capital Structure - Following the capital increase, BioPorto's Articles of Association have been updated to reflect the new share capital structure [4] - The company emphasizes its commitment to transparency and provides access to its announcements and relevant information through its investor relations platform [4]
Rakovina Therapeutics Showcases Compelling Preclinical Data on AI-Discovered CNS-Penetrant ATR/mTOR Inhibitors at the 2025 Society for Neuro-Oncology Annual Meeting
Globenewswire· 2025-11-24 09:00
Core Insights - Rakovina Therapeutics has announced significant advancements in its AI-enabled ATR program, showcasing novel ATR/mTOR dual inhibitors designed for brain penetration and efficacy in PTEN-deficient tumor models [1][2][10] Group 1: Discovery and Development - The company presented a poster at the 2025 Society for Neuro-Oncology Annual Meeting detailing the discovery of CNS-penetrating ATR inhibitors that combine ATR and mTOR inhibition, targeting PTEN-deficient tumors [2][4] - The lead molecules were specifically engineered to cross the blood-brain barrier, making them potentially effective against primary brain cancers and those with a high risk of brain metastasis [2][4] Group 2: Efficacy and Mechanism - The AI-discovered ATR/mTOR inhibitors demonstrated over 50% ATR inhibition at 1 µM, showing comparable or superior potency to existing ATR inhibitors like ceralasertib, tuvusertib, and elimusertib [3][7] - These compounds are designed to co-target ATR and mTOR pathways, which are critical for the survival of PTEN-deficient tumors, potentially overcoming resistance mechanisms associated with ATR-only therapies [4][6] Group 3: Clinical Relevance and Future Directions - The pharmacokinetic profiling indicated favorable tolerability and measurable CNS exposure in mice, supporting further evaluation in brain tumor models [8][9] - The company aims to advance its pipeline of DNA-damage response inhibitors into human clinical trials, leveraging AI technologies for rapid drug candidate optimization [11][12]
Global Expansion Accelerates: Landmark UAE Driverless Robotaxi Commercial Permit, Autonomous Vehicles Licensed in Eight Countries, Record YoY Revenue Growth of 144.3%
Globenewswire· 2025-11-24 09:00
Core Insights - WeRide Inc. reported a significant increase in total revenue, growing 144.3% year-over-year to RMB171.0 million (US$24.0 million) in Q3 2025, driven by global fleet expansion and service penetration [4][12] - The company achieved multiple regulatory breakthroughs, including securing fully driverless robotaxi commercial permits in Abu Dhabi and Switzerland, enhancing its operational capabilities [4][8] - WeRide's gross profit surged 1,123.9% year-over-year to RMB56.3 million (US$7.9 million), with a gross profit margin of 32.9%, a substantial increase from 6.5% in Q3 2024 [4][17] Financial and Operational Highlights - Total revenue reached RMB171.0 million (US$24.0 million), marking a 144.3% increase from RMB70.0 million in Q3 2024 [12] - Product revenue increased by 428.0% year-over-year to RMB79.2 million (US$11.1 million), while service revenue grew 66.9% to RMB91.8 million (US$12.9 million) [15] - Robotaxi revenue experienced a remarkable growth of 761.0% year-over-year, reaching RMB35.3 million (US$5.0 million) [4] - As of September 30, 2025, WeRide had cash and cash equivalents totaling RMB5.4 billion (US$764.1 million) [4] Global Commercialization Efforts - WeRide operates an autonomous vehicle fleet of over 1,600 vehicles, with nearly 750 being robotaxis, and has secured regulatory approvals in eight countries [4][8] - The company launched public operations in Saudi Arabia and Belgium, and initiated road tests in Zurich, Dubai, and Singapore [4][8] - In Guangzhou, WeRide's robotaxi services completed approximately four times more trips in Q3 2025 compared to Q2 2025, with each vehicle completing up to 25 trips daily [4] Regulatory Achievements - WeRide received a city-level fully driverless robotaxi commercial permit in Abu Dhabi, allowing operations without an in-vehicle safety officer, achieving unit economics breakeven [8] - The company also obtained a driverless permit in Switzerland, enabling operations in the Furttal region with a planned launch of public passenger services in early 2026 [8] Management Commentary - The CEO highlighted the convergence of advanced technology and global execution capabilities, emphasizing the importance of regulatory achievements in validating the path to profitability [11] - The CFO noted substantial improvements in growth trajectory and operational leverage, with a diversified portfolio supporting sustained growth [11]
Genenta Reports Long-Term Survival Trends and Immune Findings in Brain Tumor (GBM) Trial
Globenewswire· 2025-11-24 09:00
Core Insights - Genenta Science has provided an update on its TEM-GBM study for newly diagnosed glioblastoma multiforme (GBM) patients with an unmethylated MGMT gene promoter, reporting that 25 patients have been treated with Temferon as of November 21, 2025 [1][2] Group 1: Clinical Study Results - Key survival metrics for TEM-GBM patients show that 44% of patients have reached 18-month survival, an increase from 38% reported in April 2025 [7] - The two-year survival rate remains at 29%, and the median overall survival is consistent at 17 months, compared to historical cohorts of uMGMT patients treated with standard care, which typically show a two-year survival rate of approximately 14% and median overall survival of 13-15 months [7] - The study includes a patient who has reached three years of survival following Temferon administration, marking a significant milestone in the study [7] Group 2: Mechanism and Observations - The GBM study provides early observations on Temferon's behavior within the tumor microenvironment, indicating that bone-marrow-derived myeloid cells can deliver immunotherapeutic payloads at the tumor site, aligning with the platform's intended design [3] - These preliminary findings are exploratory and will inform the broader development of Temferon, including potential combination approaches and the evolution of the underlying cell-based delivery technology [3] Group 3: Financial Position - Following a registered direct offering on October 27, the company reported approximately $30 million in cash and short-term investments as of November 1, 2025 [4] Group 4: Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for various solid tumor cancers, with Temferon as its first-in-class product candidate [5] - The company has completed a Phase 1 trial for newly diagnosed GBM patients with an unmethylated MGMT gene promoter, suggesting potential reprogramming of the tumor microenvironment and induction of T cell responses [5] - Genenta has also initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5]
Danske Bank share buy-back programme: transactions in week 47
Globenewswire· 2025-11-24 09:00
Core Viewpoint - Danske Bank has initiated a share buy-back program totaling DKK 5 billion, aiming to repurchase up to 45 million shares from February 10, 2025, to January 30, 2026 [1][2]. Group 1: Share Buy-Back Program Details - The share buy-back program is conducted in compliance with the Market Abuse Regulation and Safe Harbour Rules [2]. - As of the last announcement, Danske Bank has repurchased a total of 15,439,475 shares, with a weighted average price (VWAP) of DKK 249.3755, amounting to a gross value of DKK 3,850,227,432 [3][4]. - In week 47, the bank repurchased an additional 592,113 shares at a VWAP of DKK 287.4287, totaling a gross value of DKK 170,190,270 [3][4]. Group 2: Cumulative Transactions - The total number of shares repurchased during the entire buy-back program has reached 16,031,588, with an average price of DKK 250.7810, resulting in a total gross value of DKK 4,020,417,702 [4]. - The total shares repurchased correspond to 1.920% of Danske Bank's share capital [4].
Westhaven Advances Exploration and Development Programs at Shovelnose Gold Project, Southern British Columbia
Globenewswire· 2025-11-24 09:00
Core Insights - Westhaven Gold Corp. has successfully completed an upsized summer drilling program at its 100%-owned Shovelnose Gold Project, confirming the resource model and validating a new exploration model for potential gold mineralization [1][3][6]. Drilling Program Overview - The 2025 summer drilling program consisted of 13 drill holes totaling 6,202 meters, which is more than double the initially planned 3,000 meters [4][6]. - Drilling focused on structural and geochemical targets, confirming significant structural offsets and the presence of epithermal mineralization [3][6]. Resource Confirmation - Drill holes SN25-432 and SN25-442 confirmed the resource model by intersecting expected intervals of epithermal mineralization, including notable grades of gold and silver [7][8]. - The South Zone resource model has been validated, indicating strong potential for additional epithermal gold systems [6][14]. Economic Assessment - The March 2025 Preliminary Economic Assessment (PEA) outlines an 11-year underground mining opportunity with an after-tax NPV of CAD$454 million and an IRR of 43.2% at a gold price of US$2,400 per ounce [6][19]. - Initial capital costs are projected at CAD$184 million, with a payback period of 2.1 years [19]. Strategic Location - The Shovelnose project is strategically located 2.5 hours from Vancouver, providing direct road and power access, which significantly reduces exploration and development costs compared to more remote projects [6][19]. Exploration Potential - The exploration program has identified a 100 km strike extent of the Spences Bridge Gold Belt, with over 1,800 geochemical samples collected, indicating substantial regional exploration potential [6][19]. - The company aims to continue systematic exploration drilling to unlock new discoveries and prepare for integrated engineering and environmental studies for project development [14][19]. Technical Leadership - Westhaven's technical team has been strengthened with new appointments, including CEO Ken Armstrong and other key positions, bringing world-class expertise to the exploration and development strategy [6][19].