Amplia Therapeutics Reports Four Additional Complete Responses and Improved Overall Survival Data in Accent Pancreatic Cancer Trial
Globenewswire· 2026-03-23 12:45
Core Insights - Amplia Therapeutics Limited announced mature data from the ACCENT clinical trial for advanced pancreatic cancer, showing a median overall survival of 11.1 months and five complete responses recorded to date [2][9]. Clinical Trial Data - The ACCENT trial has reported a confirmed complete response (CR) rate of 7.8% (5 out of 64 patients) for those receiving a 400 mg dose of narmafotinib, which is unprecedented for this indication [3][9]. - An updated Objective Response Rate (ORR) of 35.9% (23 out of 64 patients) has been established, with one patient nearing 24 months on the trial [4][9]. - The median overall survival (mOS) of 11.1 months represents a two-month improvement compared to the standard gemcitabine-Abraxane chemotherapy [6][9]. Comparative Analysis - The ACCENT trial data compares favorably to historical data from the MPACT and NAPOLI 3 trials, with the mOS of 11.1 months being identical to that of the NALIRIFOX regimen, which received FDA approval [7][8]. - The complete response rate of 7.8% in the ACCENT trial significantly exceeds the rates of 0.2% and 0.3% reported in the MPACT and NAPOLI 3 trials, respectively [8]. Safety and Tolerability - Narmafotinib has been well tolerated by patients, with the adverse effect profile similar to that of chemotherapy alone [8][9]. Upcoming Presentations - The company has been selected to present trial data at the American Association of Cancer Research (AACR) annual meeting in April 2026 [10][11].
Anmodning om ophør af suspension i enkelte afdelinger under Investeringsforeningen Danske Invest og Investeringsforeningen Danske Invest Select
Globenewswire· 2026-03-23 12:36
Group 1 - The core point of the news is the request for suspension of certain classes under Danske Invest due to NAV uncertainty, effective March 23, 2026 [1] - The affected departments/classes are listed, including "Fjernøsten Indeks, klasse DKK d," "Nye Markeder, klasse DKK d," "Nye Markeder - Akkumulerende, klasse DKK," and "Nye Markeder 2, klasse DKK d" [1] - Each affected class is identified by its ISIN code and OMX identification number, providing clarity on which specific funds are impacted [1]
Knight Amends Normal Course Issuer Bid
Globenewswire· 2026-03-23 12:36
Core Viewpoint - Knight Therapeutics Inc. has announced an amendment to its Normal Course Issuer Bid (NCIB), increasing the maximum number of common shares to be repurchased from 3,000,000 to 6,190,493, which represents approximately 10% of the public float as of August 8, 2025 [1]. Group 1: Share Repurchase Details - The company intends to repurchase common shares for cancellation through the Toronto Stock Exchange (TSX) or alternative Canadian trading systems, with the number and timing to be determined by the company [2]. - From August 22, 2025, to March 19, 2026, the company has already purchased 1,767,300 common shares at a weighted average price of $6.08 per share [2]. Group 2: Automatic Share Purchase Plan - Knight has amended its Automatic Share Purchase Plan (ASPP) with its broker to align with the increased number of common shares authorized for repurchase under the amended NCIB, allowing the broker to repurchase shares even during regulatory restrictions or blackout periods [3]. Group 3: Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company based in Montreal, Canada, focused on acquiring, in-licensing, and commercializing pharmaceutical products for Canada and Latin America, with subsidiaries operating under United Medical, Biotoscana Farma, and Laboratorio LKM [4].
Syntec Optics (Nasdaq: OPTX) Positions for Onshoring of Advanced Optical Systems Under New National Defense Authorization Act (NDAA) Mandate
Globenewswire· 2026-03-23 12:35
Core Viewpoint - Syntec Optics is strategically positioned to benefit from the newly enacted National Defense Authorization Act (NDAA), which emphasizes domestic sourcing for optical systems, aligning with the company's U.S.-based production capabilities [1][3][6] Group 1: Legislative Impact - The FY2026 NDAA mandates the development of strategies to source glass and optical systems domestically, with a deadline of January 1, 2030, to eliminate reliance on adversary nations for these systems [3] - The NDAA's provisions specifically highlight the importance of domestic manufacturing in defense technology, which is beneficial for companies like Syntec Optics [6] Group 2: Company Capabilities - Syntec Optics offers a wide range of products including optics elements, optomechanicals, and optical assemblies, all manufactured in its U.S. facility, showcasing its ability to meet the demands of defense tech integrators [2][4] - The company has a proven track record in providing high-performance technology essential for modern combat environments, reinforcing its capability to comply with NDAA requirements [4] Group 3: Market Dynamics - Analysts note that escalating geopolitical conflicts are driving a global wave of military modernization, positioning domestic providers like Syntec at the forefront of this industrial shift [5] - Syntec anticipates increased demand from defense program customers who must now inventory optical bills of materials and transition to domestic sources to avoid non-compliance by the 2030 deadline [6] Group 4: Business Development - Syntec has created a new position in business development focused on aligning its capabilities with Department of War directives, enhancing engagement with military, government, and private sector leaders [7] - The company continues to expand its product lines, including optics for Low Earth Orbit satellites and lightweight night-vision goggles, reflecting its commitment to innovation in optics and photonics [7]
Critical Metals Corp. Nasdaq-CRML Announces the Successful Acquisition of the Leading Turn-Key Engineering, Mining, Construction, Infrastructure & Drilling Operator Within Greenland (60 Degree North Greenland A/S)
Globenewswire· 2026-03-23 12:35
Core Viewpoint - Critical Metals Corp. has entered into an agreement to acquire a majority shareholding in 60° North Greenland ApS, enhancing its strategic position in southern Greenland and expanding its portfolio of critical mineral projects [1][2]. Group 1: Acquisition Details - The acquisition will provide Critical Metals Corp. with additional exploration assets, operational capabilities, and local expertise in Greenland's mining sector [2]. - 60° North Greenland ApS will collaborate with the Tanbreez project to develop infrastructure and local operational capacity [3]. Group 2: Strategic Importance - This acquisition is part of Critical Metals Corp.'s mission to build a robust supply chain for critical minerals, essential for defense applications, clean energy transition, and next-generation technologies [4]. - The company aims to strengthen its position as a reliable supplier of critical materials for the United States, Europe, and their partners [4]. Group 3: Company Background - Critical Metals Corp. is focused on critical metals and minerals, with its flagship project, Tanbreez, being one of the largest rare earth deposits globally, located in southern Greenland [7]. - The Wolfsberg Lithium Project in Austria is another key asset, expected to be a major producer of lithium products for the European market [8].
Lakeland Fire + Safety Receives Additional NFPA 1970 Certifications for Gloves, Hoods, Helmets, Structural Turnout and Proximity Gear
Globenewswire· 2026-03-23 12:31
Core Insights - Lakeland Industries, Inc. has achieved NFPA 1970:2025 certification for a range of firefighter Personal Protective Equipment (PPE), enhancing its market leadership and product offerings [1][4][5] Product Certification - The newly certified products include Lakeland Structural Turnout and Proximity Gear, Veridian Gloves, Fire Particulate Blocking Hoods, and Pacific Helmets, completing a full head-to-toe range of certified PPE [1][3] - The NFPA 1970:2025 standard introduces new requirements for protective ensembles, including restrictions on substances, compatibility with Personal Alert Safety Systems (PASS), and improved cleaning protocols [2] Market Availability - Lakeland anticipates that the certified Structural Turnout Gear and Proximity Gear from its manufacturing facilities in Mexico and China, along with made-in-the-USA Veridian Gloves and Fire Particulate Blocking Hoods, will be available in the market shortly [3] Innovation and Leadership - The company emphasizes its commitment to innovation and quality, as highlighted by the rapid achievement of multiple certifications, which allows customers to order certified gear across its entire brand portfolio [4] - Lakeland aims to set new benchmarks for performance and protection in firefighter PPE, with plans to showcase new certified products at FDIC 2026 [5] Company Overview - Lakeland Fire + Safety manufactures a comprehensive line of protective clothing and accessories for various industries, including fire services and first responders, and operates globally with a strategic network of distributors [6]
Moleculin Hits 45 Subject Enrollment Milestone, Triggering Final Countdown to Mid-2026 MIRACLE Trial Data Readout
Globenewswire· 2026-03-23 12:31
Core Insights - Moleculin Biotech has enrolled the 45th subject in its pivotal Phase 2B/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML), marking a significant milestone for the company [1][2] - The upcoming interim data unblinding is expected in mid-2026 and is viewed as a potential inflection point for the company, with preliminary results indicating a 40% remission rate among the first 30 patients [2][3] Trial Progress - The MIRACLE trial is designed to evaluate AnnAraC across eight countries, with an initial dataset expected to include approximately 30 patients treated with AnnAraC and 15 patients in the control arm [2][4] - The trial's adaptive design aims to support a streamlined global registration pathway, integrating Phase 2B data into the Phase 3 portion, in line with regulatory guidance [4] Efficacy and Safety - Preliminary results from the trial show a composite complete remission rate of 40%, with 30% achieving complete remission and 10% achieving complete remission with partial hematologic recovery, despite many patients having previously failed venetoclax-based therapies [3][5] - The absence of cardiotoxicity in over 100 patients treated to date is a notable achievement for the company [2][5] Future Outlook - The company is advancing toward a total enrollment of 90 subjects, with the completion of Part A of the MIRACLE trial expected in Q3 2026 [2][4] - The successful outcomes from the trial could lead to a potential accelerated approval pathway based on the primary endpoint of complete remission [4][5]
RenovoRx Announces Closing of Oversubscribed $10 Million at Market Private Placement
Globenewswire· 2026-03-23 12:30
Core Viewpoint - RenovoRx, Inc. has successfully closed an oversubscribed private placement, raising approximately $10 million to support its business plan and clinical milestones, particularly for its FDA-cleared drug-delivery device, RenovoCath [1][3][6] Financing Details - The private placement was led by both new and existing institutional investors, including Transcend Partners, LLC and AIGH Capital Management LLC, with participation from RenovoRx's senior management and Board of Directors [2] - A total of 10,638,790 shares of common stock were issued at a price of $0.938 per share, along with revenue milestone warrants for an additional 5,319,392 shares [4] - The exercise price for the revenue milestone warrants is set at $1.751, representing a 100% premium to the offering price [5] Business Strategy and Milestones - The proceeds from the financing will be utilized to accelerate the market adoption of RenovoCath and advance clinical development, with a focus on achieving full enrollment in the pivotal Phase III trial by mid-2026 [3][7] - The company anticipates significant growth in commercial revenues, which will help reduce cash burn and support the goal of cash-flow breakeven operations [3] Leadership and Team - Mark Voll has been appointed as Chief Financial Officer, bringing a strong track record of scaling public companies [3] - The company has established a core, nimble, and capital-efficient commercial team for RenovoCath [3] Clinical Development - RenovoRx is nearing completion of enrollment in its pivotal Phase III TIGeR-PaC clinical trial, with results expected in 2027 [3][7] - The trial involves 16 additional commercial centers that are already trained on RenovoCath procedures and have begun purchasing devices [3] Product Overview - RenovoCath is designed for targeted delivery of fluids to specific sites in the peripheral vascular system and is indicated for temporary vessel occlusion [10][11] - The company is also evaluating a novel drug-device combination product candidate, intra-arterial gemcitabine delivered via RenovoCath, in the ongoing Phase III trial [13][14]
House of Doge Welcomes New SEC Guidance Providing Clarity on Crypto Assets Like Dogecoin
Globenewswire· 2026-03-23 12:30
Core Viewpoint - The new guidance from the SEC and CFTC clarifies that not all digital assets are securities, which is a significant advancement for assets like Dogecoin that emphasize real-world utility and everyday use [1][2]. Regulatory Clarity - The guidance provides essential clarity for the crypto industry, distinguishing between investment contracts and assets functioning as commodities or digital goods, which is particularly relevant for Dogecoin [2][5]. - This regulatory direction reduces uncertainty in the crypto ecosystem, encouraging innovation and product development that integrates digital assets into daily financial experiences [3]. Focus on Utility - House of Doge is committed to enhancing the real-world utility of Dogecoin by developing infrastructure that facilitates its use in the payments ecosystem [4]. - The company aims to bridge Dogecoin with modern payment systems, making it more usable and accessible in everyday transactions [4][6]. Industry Perspective - The clarity provided by the SEC is viewed as a validation of Dogecoin's role as a currency with real utility, rather than a speculative instrument [5]. - The merger between House of Doge and Brag House is seen as a strategic move to leverage this regulatory clarity for scaling operations [5]. Company Initiatives - House of Doge is focused on building secure and efficient systems for Dogecoin's integration into everyday commerce, including payment solutions and financial products [6]. - The company is also working on enabling peer-to-peer payments and supporting merchant acceptance of Dogecoin both online and in-store [8].
Vaxcyte Completes Enrollment of OPUS-1 and OPUS-2 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults
Globenewswire· 2026-03-23 12:30
Core Insights - Vaxcyte, Inc. has completed enrollment in two pivotal Phase 3 trials (OPUS-1 and OPUS-2) for its next-generation pneumococcal conjugate vaccine, VAX-31, which aims to establish a new standard of care for adult pneumococcal vaccines [1][2][3] Group 1: OPUS-1 Phase 3 Study - The OPUS-1 trial is a noninferiority study with approximately 4,000 participants, evaluating the safety, tolerability, and immunogenicity of VAX-31 compared to existing vaccines PCV21 and PCV20 [1][3] - The study targets healthy, pneumococcal-naïve adults aged 50 years and older, with a separate cohort of adults aged 18-49 years [3][4] - Results from the OPUS-1 trial are expected in the fourth quarter of 2026, supporting a planned Biologics License Application (BLA) submission [1][2] Group 2: OPUS-2 Phase 3 Study - The OPUS-2 trial, now fully enrolled with approximately 1,300 adults, evaluates the concomitant administration of VAX-31 with a seasonal influenza vaccine [1][8] - This study aims to provide real-world performance insights and is designed to inform potential post-licensure outcomes studies [8] - Results from the OPUS-2 trial are anticipated in the first half of 2027 [1][2] Group 3: Immunogenicity and Safety - The primary immunogenicity objective for OPUS-1 is to demonstrate noninferiority of VAX-31 compared to PCV21 and PCV20 for 28 shared serotypes in adults aged 50 years and older [5][11] - Key secondary objectives include assessing the superiority of VAX-31 for unique serotypes and comparing immune responses across different age groups [11][14] - Safety and tolerability will be monitored for six months following vaccination in both trials [4][9] Group 4: VAX-31 Vaccine Profile - VAX-31 is a 31-valent pneumococcal conjugate vaccine designed to cover approximately 95% of invasive pneumococcal disease (IPD) and 88% of pneumococcal pneumonia in adults aged 50 and older [16] - The vaccine aims to provide incremental coverage improvements over current standard-of-care vaccines, potentially increasing IPD coverage by 14-34% and pneumonia coverage by 19-31% [16] - VAX-31 has received Breakthrough Therapy designation from the FDA for the prevention of pneumonia in addition to IPD, based on positive Phase 1/2 study results [17]