Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer
Globenewswire· 2025-05-31 12:00
Core Insights - The Phase 3 VERITAC-2 clinical trial results indicate that vepdegestrant monotherapy shows a statistically significant improvement in progression-free survival (PFS) for patients with ESR1 mutations compared to fulvestrant [2][4][6] - Vepdegestrant is positioned as a potential best-in-class treatment option for patients with ER+/HER2- advanced or metastatic breast cancer, particularly in the second-line setting [4][7][12] Group 1: Clinical Trial Results - Vepdegestrant reduced the risk of disease progression or death by 43% in patients with ESR1 mutations, with a median PFS of 5.0 months compared to 2.1 months for fulvestrant [2][3] - In the intent-to-treat population, the median PFS was 3.7 months for vepdegestrant versus 3.6 months for fulvestrant, which did not reach statistical significance [2][4] - The clinical benefit rate (CBR) for vepdegestrant was 42.1% compared to 20.2% for fulvestrant, and the objective response rate (ORR) was 18.6% versus 4.0% respectively [4][6] Group 2: Safety and Tolerability - Vepdegestrant was generally well tolerated, with low rates of gastrointestinal adverse events such as nausea (13.5%), vomiting (6.4%), and diarrhea (6.4%) [3][5] - The incidence of grade 4 treatment-emergent adverse events (TEAEs) was 1.6% in the vepdegestrant arm compared to 2.9% in the fulvestrant arm [3][5] - TEAEs leading to treatment discontinuation occurred in 2.9% of patients taking vepdegestrant versus 0.7% for fulvestrant [3][5] Group 3: Market and Development Potential - Approximately 2.3 million new breast cancer diagnoses were reported globally in 2022, with ER+/HER2- breast cancer accounting for about 70% of cases [6][12] - The companies plan to submit a New Drug Application (NDA) for vepdegestrant to the FDA in the second half of 2025 [7][12] - Vepdegestrant is the first PROTAC evaluated in a Phase 3 clinical trial, indicating a novel approach in treating breast cancer [5][7]
Xilio Therapeutics Announces Updated Phase 2 Data for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer
Globenewswire· 2025-05-31 12:00
Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]
Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma
Globenewswire· 2025-05-31 12:00
Phase III NAPOLI 3 trial is the largest and has the longest follow-up for an interventional study in metastatic pancreatic adenocarcinoma1 Post-hoc analysis of NAPOLI 3 study determined characteristics associated with long-term survival, with median overall survival of 19.5 months amongst long-term survivors receiving Onivyde® plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy2 Dose reductions and/or treatment delays for the management of adverse events enabled patient ...
WithSecure has completed the transaction of Cyber security consulting divestment to Neqst
Globenewswire· 2025-05-31 06:45
Core Points - WithSecure Corporation has completed the divestment of its cyber security consulting business to Neqst, a Swedish investment company [1][2] - The transaction was finalized on 31 May 2025, with a cash payment of EUR 13.5 million, which is 60% of the agreed enterprise value of EUR 22.5 million, after deducting the transferring net assets [2] - The remaining 40% of the purchase price is variable and will be based on the business performance in 2025 and 2026, payable in two installments at the beginning of 2026 and 2027 [2] - Approximately 230 employees from various countries including Finland, UK, Sweden, Denmark, Singapore, Italy, and the US will transfer to Neqst as part of the transaction [3] - The divestment allows WithSecure to focus on its Elements strategy, aiming to become a leading player in European cybersecurity [3]
Fenjiu Captivates Milan at 2025 Chinese Brands Going Global Worldwide Tour
Globenewswire· 2025-05-31 03:12
Core Insights - The event "2025 Chinese Brands Going Global· Worldwide Tour" was launched in Milan, focusing on promoting Chinese brands globally, with Fenjiu as a key participant [1] - Fenjiu aims to bridge the gap between "Chinese-famous liquor" and "world-famous liquor" through its commitment to quality and cultural heritage [3][4] Company Strategy - Fenjiu's global expansion strategy includes cultural immersion and market penetration, utilizing overseas Chinese networks and engaging in cocktail mixology to attract international consumers [5] - The company has expanded to over 60 countries and regions, with more than 100 distributors, 9,000 retail outlets, and 180 duty-free stores worldwide [5] Cultural Engagement - Fenjiu emphasizes cultural dialogue and value resonance in its internationalization efforts, focusing on cultural engagement through tastings and participation in international spirits fairs [8][9] - The company has adopted a "key cities + core channels" strategy, targeting major cities like Milan and Rome, and partnering with high-end Chinese restaurants and gourmet supermarkets [10] Historical Context - Fenjiu's international journey began in 1992, and it has since led Chinese baijiu in international standards and quality control [11] - The company has accelerated its globalization efforts, opening experience centers in cities like Cologne, Singapore, and Macao, and becoming the official liquor of the 2023 BRICS Summit in South Africa [11]
New Data from Teva Shows Substantial Rates of Undertreated Tardive Dyskinesia in Long-Term Care Settings at Psych Congress Elevate 2025
Globenewswire· 2025-05-31 01:05
Core Insights - Teva Pharmaceuticals has highlighted a significant gap in the diagnosis and treatment of tardive dyskinesia (TD) among patients in long-term care (LTC) facilities, emphasizing the need for improved awareness and understanding of this condition [1][2][3] Study Findings - The study analyzed a database of approximately 700,000 residents on antipsychotic drugs (APDs) and about 35,000 on metoclopramide (Reglan), revealing that mood disorders were the most common underlying psychiatric diagnoses, affecting 68% and 54% of residents respectively [2][7] - More than half of the residents with TD in LTC settings do not receive standard care treatment, and one-quarter remain untreated, indicating a critical need for better diagnostic practices [6][7] - Among residents treated with APDs, only 1.1% had a specific diagnosis of TD, while 5.6% were diagnosed with extrapyramidal syndrome (EPS), which can lead to inappropriate treatment options [7] Implications for Care - The findings suggest that many individuals with TD in LTC facilities are at risk of not receiving appropriate diagnoses or standard care, necessitating more intensive evaluations to improve treatment accuracy [3][6] - Less than half of the patients diagnosed with TD received the recommended standard of care treatment, primarily a vesicular monoamine transporter 2 inhibitor (VMAT2i), with many being treated with non-FDA approved options [7]
NEW WAVE ANNOUNCES Closing of Non-Brokered Private Placement of Units
Globenewswire· 2025-05-31 00:08
Core Points - New Wave Holdings Corp. has successfully closed a non-brokered private placement, raising gross proceeds of $385,000 by issuing 7,000,000 units at a price of $0.055 per unit [1][2] - Each unit consists of one common share and one transferable common share purchase warrant, allowing the purchase of an additional share at $0.07 from August 13, 2025, until May 30, 2027 [2] - The proceeds from the offering will be utilized for future portfolio investments, supporting current investments, and general working capital [2] Regulatory and Offering Details - The offering was completed under the Listed Issuer Financing Exemption as per National Instrument 45-106, and the securities issued are not subject to a hold period under Canadian securities laws [3] - An amended and restated offering document related to this LIFE Offering is available on the Company's profile and website [4] - The securities issued will not be registered under the U.S. Securities Act and cannot be offered or sold within the United States without proper registration or exemption [5] Company Overview - New Wave Holdings Corp. is an investment issuer focused on supporting innovative and fast-growing companies in the esports, Artificial Intelligence, Blockchain, and Web3 sectors [6]
Lancaster Resources Announces Closing Conditions Met for Lake Cargelligo Acquisition
Globenewswire· 2025-05-31 00:06
Core Viewpoint - Lancaster Resources Inc. has received approval to acquire the Lake Cargelligo Gold Project and has completed a $400,000 private placement financing, expecting the acquisition to close imminently [1][2]. Acquisition Terms - Lancaster will acquire a 100% interest in the Lake Cargelligo Gold Project with no finders' fees payable [2]. - The vendors will retain a 2% net smelter returns (NSR) royalty on all mineral production, with Lancaster having the option to repurchase 1% of the NSR for $2,000,000 [3]. - Lancaster must incur $400,000 in exploration expenditures within 12 months of closing, with a second optional work commitment of $3,000,000 over 36 months [4]. Milestone Payments - Milestone payments totaling up to $3.68 million are structured as follows: - $10,000 in cash at closing - $30,000 upon completion of the first geophysics program - $50,000 on commencement of the first drill program - $50,000 upon raising $1,000,000 post-closing - $50,000 upon receipt of conditional ASX listing approval - $500,000 on a NI 43-101 or JORC-compliant 1Moz gold resource - $1,000,000 on a NI 43-101 or JORC-compliant PEA for a 1Moz resource - $2,000,000 on a NI 43-101 or JORC-compliant PFS for a 1Moz resource [6]. Project Highlights - The Lake Cargelligo Gold Project covers 28,768 hectares with over 25 km of prospective strike and three primary target zones [5]. - Historical sampling results include high-grade findings of up to 204 g/t Au and 273 g/t Ag from rock chips, and up to 16m at 5.83 g/t Au and 7.20 g/t Ag from channel sampling [5]. Company Overview - Lancaster Resources Inc. is focused on advancing a diversified portfolio of critical mineral and precious metal assets, including the Piney Lake Gold Project and uranium exploration projects in Saskatchewan, as well as the Alkali Flat Lithium Project in New Mexico [8].
Trillion Energy Announces Debt Settlements
Globenewswire· 2025-05-31 00:00
Core Points - Trillion Energy International Inc. proposes to issue 2,237,082 common shares to settle $101,854.10 in debt owed to consultants and an officer [1] - A total of 573,002 common shares are being issued specifically for management services from an officer, categorized as an Insider Settlement [2] - The Insider Settlement is classified as a related-party transaction under Multilateral Instrument 61-101, with exemptions from formal valuation and minority shareholder approval due to the fair market value not exceeding 25% of the company's market capitalization [3] Company Overview - Trillion Energy International Inc. focuses on oil and natural gas production in Europe and Türkiye, holding a 49% interest in the SASB natural gas field and a 19.6% interest in the Cendere oil field [4]
Hydreight Reports 34% Year-Over-Year Q1 Revenue Growth, Improvement in Bottom Line Results, and Delivers Strong Performance Across Verticals
Globenewswire· 2025-05-30 23:46
Core Insights - Hydreight Technologies Inc. reported a strong Q1 2025 with approximately 34% year-over-year growth, indicating the effectiveness of its strategy [1][3] - The company secured new customers for its VSDHOne platform, which is expected to contribute positively to year-end goals [3] - Continued investments in the first half of 2025 are aimed at scaling operations efficiently and improving margins [1][3] Financial Performance - Topline revenue reached CAD 6.53 million, a 34% increase year-over-year [5] - GAAP revenue was CAD 4.54 million, up from CAD 3.38 million in Q1 2024 [5] - Gross margin improved to CAD 1.50 million from CAD 1.23 million in Q1 2024 [5] - Adjusted EBITDA was CAD 163K, reflecting ongoing operational improvements [5] - GAAP net income was CAD 21K, a significant turnaround from a net loss of CAD 309K in Q1 2024 [5] - Cash on hand at the end of the quarter was CAD 6.04 million [5] Growth Metrics - New nurse signups grew by approximately 65% compared to Q1 2024 [5] - The number of pharmacy orders increased by approximately 48% compared to Q1 2024 [5] Strategic Developments - Hydreight launched a Personalized Genetic Testing and Wellness Solution on the VSDHOne platform on May 27, 2025 [6] - The company expanded its telehealth services with new offerings, including GLP-1 therapies and partnerships with healthcare professionals [6][9] - Hydreight was recognized as one of the fastest-growing companies in the Americas by Financial Times [9] Future Outlook - The company aims to focus on growth across three verticals, achieve sustained positive adjusted EBITDA, and expand its service offerings [16] - Key priorities include onboarding high-volume franchise and direct-to-consumer partners and pursuing strategic mergers and acquisitions [16]