Arvinas Announces Data Presentations from the Vepdegestrant (ARV-471) Clinical Development Program at the 2025 San Antonio Breast Cancer Symposium (SABCS)
Globenewswire· 2025-11-24 12:00
Core Viewpoint - Arvinas, Inc. announced that multiple abstracts on vepdegestrant (ARV-471), a novel investigational PROTAC estrogen receptor degrader, have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) scheduled for December 9-12, 2025, highlighting its potential as a treatment for advanced or metastatic breast cancer with ESR1 mutations [1][5][6] Presentation Details - The presentation titled "Subgroup analyses of VERITAC-2" will be led by Erika P. Hamilton, focusing on vepdegestrant versus fulvestrant in ER+/HER2- advanced breast cancer [2] - Another presentation will cover circulating tumor DNA biomarker analyses in a phase 1/2 study of vepdegestrant, presented by Seth A. Wander [2] - David Chandiwana will present on the real-world prevalence of ESR1 mutations among patients with ER+/HER2- metastatic breast cancer after first-line treatment [2] - Jo Chien will present on the I-SPY2 Endocrine Optimization Pilot trial evaluating vepdegestrant in combination with other therapies [2] About Vepdegestrant - Vepdegestrant is an orally bioavailable PROTAC estrogen receptor degrader that has shown statistically significant improvement in progression-free survival compared to fulvestrant in patients with ESR1-mutated advanced breast cancer [5] - The FDA is currently reviewing the New Drug Application (NDA) for vepdegestrant, with a Prescription Drug User Fee Act (PDUFA) action date set for June 5, 2026, and it has received Fast Track designation [5] Collaboration with Pfizer - Arvinas has a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant, sharing worldwide development costs and profits [6] - In September 2025, both companies announced plans to select a third party for the commercialization and further development of vepdegestrant [6] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies through its PROTAC platform, targeting various diseases including advanced breast cancer [7] - The company is advancing multiple investigational drugs, including ARV-102 for neurodegenerative disorders and ARV-393 for non-Hodgkin lymphoma, alongside vepdegestrant [7]
Brunswick Exploration to Begin a Lithium Exploration Initiative in the Kingdom of Saudi Arabia
Globenewswire· 2025-11-24 12:00
Core Insights - Brunswick Exploration Inc. has identified Saudi Arabia as a highly prospective region for lithium exploration and has been awarded an exploration license, marking its first systematic exploration program in the country [1][2] - The exploration license covers an area of 8,467 hectares, located approximately 150 km from Buraydah and 450 km east of Riyadh, with favorable geological conditions for lithium [3][4] - Saudi Arabia is positioning itself as a major lithium processing hub as part of its Saudi Vision 2030 initiative, which aims to diversify its economy beyond oil and gas [5] Company Developments - The exploration license is pending final government approval, and the company is completing administrative requirements to begin exploration [3] - A prospecting campaign is planned to commence in the first half of 2026, allowing the company to generate results year-round by leveraging its expertise in lithium exploration [2] - The company is also advancing its projects in Canada and Greenland, with a maiden resource estimate for the Mirage project expected in early Q1 2026 [1][2] Industry Context - Saudi Arabia has a well-established mining history, supportive government policies, and strong funding for mining initiatives, making it an attractive jurisdiction for lithium exploration [4] - The region has seen little historical hard rock lithium exploration, presenting a significant opportunity for the company [4] - Prominent mining companies are actively exploring in Saudi Arabia, indicating a growing interest in the region's mineral resources [5]
Biomea Fusion to Participate at Upcoming Investor Conferences
Globenewswire· 2025-11-24 12:00
Core Insights - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for diabetes and obesity [2] - The company will participate in two upcoming investor conferences, providing opportunities for engagement with investors [1][4] Company Overview - Biomea Fusion is advancing therapies such as icovamenib, a selective menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist for obesity [2] - The company's mission is to deliver transformative treatments for patients with diabetes, obesity, and related conditions, addressing a significant global health challenge [2] Upcoming Events - Biomea will participate in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, with a fireside chat at 8:00 AM (EST) and one-on-one meetings [4] - The company will also take part in the 8th Annual Evercore Healthcare Conference on December 3, 2025, with a fireside chat at 7:30 AM (EST) [4]
Ocular Therapeutix™ Announces First Patient Randomized in HELIOS-3 Phase 3 Registrational Program for AXPAXLI™ in NPDR
Globenewswire· 2025-11-24 12:00
Core Insights - The initiation of the HELIOS registrational program represents a significant advancement in the treatment of diabetic retinal disease, with AXPAXLI potentially addressing the needs of over 6 million NPDR patients in the U.S. who currently receive minimal therapy due to treatment burdens [2][3] - The HELIOS-2 and HELIOS-3 trials are designed to evaluate the efficacy of AXPAXLI in treating non-proliferative diabetic retinopathy (NPDR) and aim for a broad diabetic retinopathy label, including patients with non-center-involved diabetic macular edema (non-CI-DME) [2][3][12] - AXPAXLI is expected to provide durable efficacy with less frequent dosing, which could significantly improve patient adherence and outcomes compared to current treatment options that require frequent injections [2][3][12] Company Overview - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience through innovative treatments for retinal diseases, including AXPAXLI, which is currently in Phase 3 clinical trials for wet AMD and NPDR [14][15] - AXPAXLI is a bioresorbable intravitreal hydrogel that incorporates axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties, aimed at treating various retinal diseases [4][5] HELIOS Program Details - The HELIOS program consists of two complementary superiority studies: HELIOS-2 and HELIOS-3, which will assess the safety and efficacy of AXPAXLI in approximately 432 and 930 subjects, respectively, with moderately severe to severe NPDR [6][9] - Both studies utilize a novel ordinal diabetic retinopathy severity score (DRSS) as the primary endpoint, focusing on changes in severity at Week 52 from baseline [8][11] - HELIOS-2 compares AXPAXLI dosed every 12 months to ranibizumab, while HELIOS-3 evaluates different dosing regimens of AXPAXLI against sham treatment [7][10] Industry Context - Diabetic retinopathy is a prevalent condition affecting over 103 million people globally, with a significant portion of NPDR patients remaining untreated due to the burdensome nature of existing therapies [12][13] - The HELIOS trials aim to address the unmet need for effective treatments with durable efficacy, potentially transforming care for diabetic retinal disease and improving patient outcomes [3][12]
Sionna Therapeutics to Participate in Upcoming December Investor Conferences
Globenewswire· 2025-11-24 12:00
Core Insights - Sionna Therapeutics is focused on developing innovative treatments for cystic fibrosis (CF) by normalizing the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein [2][4] - The company is advancing a pipeline of small molecules aimed at correcting defects caused by the F508del genetic mutation, which is significant for improving clinical outcomes for CF patients [2] Company Overview - Sionna Therapeutics is a clinical-stage biopharmaceutical company dedicated to revolutionizing CF treatment through novel medicines that stabilize CFTR's nucleotide binding domain 1 (NBD1) [2] - The company aims to deliver differentiated medicines that restore CFTR function to near-normal levels, potentially enhancing the quality of life for individuals with CF [2] - Sionna is also developing a portfolio of complementary CFTR modulators designed to work synergistically with its NBD1 stabilizers [2] Investor Engagement - Sionna will participate in upcoming investor events, including the Annual Evercore Healthcare Conference on December 3, 2025, and the Citi 2025 Global Healthcare Conference on December 4, 2025 [4] - Live webcasts of these presentations will be available on Sionna's Investor Relations website, with replays accessible after the events [1][3]
Pasithea Therapeutics Announces Completion of Cohort 7 in Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients, with Positive Safety, Pharmacokinetic (PK), and Pharmacodynamic (PD) Data
Globenewswire· 2025-11-24 12:00
Core Insights - Pasithea Therapeutics Corp. announced positive safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from Cohort 7 (37mg capsules) in its ongoing first-in-human trial for PAS-004, a macrocyclic oral MEK inhibitor targeting MAPK pathway-driven advanced solid tumors [1][2][8] Safety and Tolerability Results - Zero treatment-related adverse events were observed during the dose-limiting toxicity (DLT) period in Cohort 7 [1][6] - The Safety Review Committee recommended proceeding to the next dose level, Cohort 8 (45mg capsules), without modifications [1][6] Pharmacodynamics (PD) Results - PD data supports continuous suppression of the MAPK pathway throughout the 24-hour dosing cycle [1][2] - PAS-004 demonstrated an ability to inhibit phosphorylated extracellular signal-regulated kinase (pERK) at levels of 80% near Cmax and above 60% at Cmin [6] Pharmacokinetics (PK) Results - The PK profile showed linearity and dose-proportionality with a Cmax/Cmin ratio of less than 2 [1][6] - Achieved AUC of 6,690 ng·h/mL, Cmax of 313 ng/mL, and Cmin of 260 ng/mL [1][6] Company Overview - Pasithea is focused on developing PAS-004 for treating RASopathies, MAPK pathway-driven tumors, and other diseases, currently in Phase 1 clinical trials for advanced cancer and neurofibromatosis type 1 [8]
A New Sheriff In Town: HyOrc Saddles Up To Power the LA-SF Rail Corridor
Globenewswire· 2025-11-24 12:00
Core Insights - HyOrc Corporation has entered into a Memorandum of Understanding (MOU) with Zero-Emission Locomotive Technologies (ZELTECH) and Dreamstar Lines to develop clean-energy locomotive solutions for the Los Angeles to San Francisco rail corridor [1][2][3] Group 1: Partnership and Collaboration - The MOU involves the use of next-generation clean-energy locomotives, including hybrid configurations powered by the HyOrc Rankine-cycle multi-fuel engine, exclusively authorized for U.S. locomotive applications by ZELTECH [2] - The collaboration aims to create a joint venture to develop, integrate, and commercialize hydrogen and multi-fuel locomotive repower systems for U.S. operators, leveraging California's zero-emission rail programs [3] Group 2: Executive Statements - Dreamstar Lines' President, Thomas Eastmond, emphasized the vision for cleaner and smarter transportation through this partnership [5] - ZELTECH's CEO, Tom Mack, highlighted the necessity for clean-power locomotives in California's railroads, stating that HyOrc's engine makes zero-emission locomotives achievable [5] - HyOrc's CEO, Reginald Fubara, noted the engine's high efficiency, reliability, and fuel flexibility, asserting that this collaboration accelerates the transition to clean commercial rail [5] Group 3: Company Developments - HyOrc Corporation has recently achieved effective Form-10 registration, making it a fully reporting public company under the Securities Exchange Act of 1934, which enhances its transparency and institutional readiness [5][6]
Village Farms Launches Promenade Brand's First Vape in Quebec
Globenewswire· 2025-11-24 12:00
Core Insights - Village Farms International, Inc. and its subsidiary Rose LifeScience Inc. have launched Promenade's first vape product, Matin, marking a significant advancement in Quebec's regulated cannabis market [1][4] - The introduction of a regulated vape category in Quebec is expected to enhance consumer access and drive growth in the legal cannabis market [2][4] Company Overview - Village Farms is a large-scale, vertically-integrated supplier of high-value plant-based Consumer Packaged Goods, leveraging decades of experience in Controlled Environment Agriculture [6] - The company operates one of the largest cannabis operations globally through its subsidiary Pure Sunfarms, with 2.2 million square feet of greenhouse production capacity [7] - Village Farms also holds an 80% stake in Rose LifeScience, a leader in cannabis product commercialization in Quebec [7] Market Dynamics - Quebec accounts for 13% of national cannabis sales, generating $202 million in cannabis revenue in Q3 2025, reflecting a 10% year-over-year increase [4] - Recent consumer data indicates that 55% of cannabis consumers in Quebec are interested in purchasing vape products from legal channels, driven by safety and quality concerns [3] Product Details - The Promenade Matin vape is designed specifically for the Quebec market, featuring a blend of cannabinoids including THC and CBG, and is characterized by bright citrus notes and a smooth finish [5] - The product will be available across Quebec starting November 26, 2025 [5]
Mirasol Signs Definitive Agreement for the Sale of the Virginia Silver Project and Landholdings in Argentina for US$8 Million Plus 2% NSR Royalty
Globenewswire· 2025-11-24 12:00
Core Viewpoint - Mirasol Resources Ltd. has signed a definitive agreement with Ampere Metals Pty. Ltd. for the sale of mineral rights and landholdings within the Virginia Silver Project in Argentina, which is expected to provide significant funding for ongoing exploration projects while retaining a royalty for shareholders [1][2]. Summary by Sections Agreement Details - The definitive agreement allows Ampere Metals to acquire 51% of the Virginia Project for a total consideration of US$4 million, with an option to acquire the remaining 49% for an additional US$4 million. Mirasol will retain a 2% net smelter royalty [3][6]. Financial Terms - The payment structure includes an initial payment of US$50,000 upon signing the memorandum of understanding, followed by various payments totaling US$8 million over 7 years, with specific amounts due at different intervals [7][6]. Resource Estimate - The Virginia Project hosts an indicated mineral resource of 11.7 million ounces of silver at a grade of 357 g/t and an inferred mineral resource of 7.9 million ounces at a grade of 184 g/t, highlighting the project's high-grade mineralization potential [2]. Company Background - Mirasol Resources Ltd. is an exploration company with over 20 years of experience in Argentina and Chile, currently self-funding exploration at its flagship Sobek Copper-Gold project and advancing a pipeline of early and mid-stage projects [10]. Ampere Metals Overview - Ampere Metals is an Australian-based mining company focused on high-quality silver-gold projects, aiming to deliver sustainable returns through economically viable assets [11].
Newton Golf Announces Insider Share Purchases After Strong Q3 Results
Globenewswire· 2025-11-24 12:00
Insiders boost ownership to 8.8% as executives signal confidence in Newton’s growth outlookCAMARILLO, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- via IBN – Newton Golf Co. (OTCQB: NWTG) said Friday that senior executives and a board member purchased shares of the company’s stock on the open market following the release of its third-quarter results. The purchases were made by Chief Executive Officer Greg Campbell, Chief Financial Officer Jeff Clayborne and independent director Brett Hoge. In total, insiders bo ...