PolTREG and U.S. Subsidiary Immuthera Secure Positive FDA Opinion, Paving the Way for a Registrational Pre-Symptomatic Type 1 Diabetes Trial
Globenewswire· 2025-07-31 18:58
Core Viewpoint - PolTREG and its U.S. subsidiary Immuthera have received a positive opinion from the FDA regarding their adaptive Phase 2/3 trial of PTG-007 for presymptomatic Type 1 diabetes, indicating sufficient clinical data to support an IND application and outlining regulatory pathways to expedite U.S. development [2][3][4]. Group 1: FDA Feedback and Study Design - The FDA has acknowledged that PolTREG's clinical data in Stage 3 Type 1 Diabetes is adequate to support the potential benefits in an adaptive Phase 2/3 study for Stage 1 and Stage 2 presymptomatic patients [4][5]. - The FDA is open to including Stage 1 Polish patients in the trial's statistical analyses, which could lower costs and accelerate data readout [4][9]. - The proposed study design, which includes a double-blind format with four treatment groups and stratification by age and HLA, has been deemed reasonable by the FDA [5][9]. Group 2: Regulatory Pathways and Future Steps - PolTREG and Immuthera plan to apply for Fast Track, Breakthrough Therapy, or Regenerative Medicine Advanced Therapy (RMAT) designation in their IND filing, which could streamline the approval process [4][9]. - The company intends to file a formal IND meeting request with the FDA in the coming weeks to advance the trial [6]. Group 3: Company Overview and Strategic Developments - PolTREG is a leader in developing autoimmune therapies based on T-regulatory cells, with PTG-007 as its lead product for early-onset Type 1 Diabetes, currently ready for Phase 2/3 clinical testing [6]. - Immuthera is focused on developing cell-based therapies in the U.S. and Canada, leveraging PolTREG's R&D capabilities and asset pipeline [7]. - Recent strategic collaborations include partnerships with Noble Capital Markets, Inc. and Kinexum Services LLC to support U.S. registration efforts, as well as a collaboration with Antion Biosciences to develop next-generation allogeneic TREG therapies [9].
RCI Banque: ‘’2025 First Half Business Report’’
Globenewswire· 2025-07-31 18:50
Core Insights - RCI Banque has released its "2025 First Half Business Report" which is accessible on the Mobilize Financial Services website [1] Group 1 - The report provides an overview of RCI Banque's performance for the first half of 2025 [1] - The financial results and key metrics are detailed in the report [1] - Stakeholders can find additional information and insights on the Mobilize Financial Services platform [1]
2025 FIRST HALF RESULTS : MOBILIZE FINANCIAL SERVICES DELIVERS SOLID GROWTH
Globenewswire· 2025-07-31 18:45
Core Insights - Mobilize Financial Services achieved a 3.8% increase in new financing in the first half of 2025 compared to the same period in 2024, reflecting strong commercial dynamics and growth in vehicle registrations [1][8] - The pre-tax profit rose by 9.7%, indicating the effectiveness of the company's strategy and commitment to sustainable mobility [2][15] - The penetration rate for electric vehicles reached 43.9%, a significant increase of 6.5 points compared to other motorization types [7][9] Commercial Performance - A total of 632,994 contracts were financed in the first half of 2025, showing a slight increase of 0.8% from the previous year [7][10] - The financing activity for used vehicles saw a minor decline of 0.4%, with 153,759 contracts financed [10] - Mobilize Lease&Co financed 120,039 operational leasing contracts, achieving a fleet under management of 655,000 vehicles, a growth of 4% [11] Financial Performance - The Net Banking Income (NBI) reached 1,132 million euros, up 5.3% year-on-year, driven by improved financial margins and increased outstanding loans [13] - Operating costs amounted to 389 million euros, reflecting a stable operating expense ratio of 1.33% relative to Average Productive Assets [14] - The Average Performing Assets (APAs) grew to 58.9 billion euros, a 7.3% increase compared to the same period in 2024 [12] Market Context - The automotive market experienced a slight growth of 0.7%, with Renault Group, Nissan, and Mitsubishi selling 1.19 million vehicles, a 2.3% increase from the first half of 2024 [8] - The overall penetration rate for financing stood at 39.6%, a slight decrease of 0.4 points compared to the previous year [9] Financing Strategy - The company raised 1.3 billion euros in the bond market during the first half of 2025, enhancing the maturity profile of subordinated debt [15] - In the securitization market, 624 million euros in automobile loan-backed securities were placed, with extensions on revolving periods for certain transactions [16] - The savings collection activity reached 30.5 billion euros, representing 49.1% of net assets, highlighting the diversification of financing sources [17][23]
Erayak Power Solution Group. Announces $7 Million Registered Direct Offering
Globenewswire· 2025-07-31 18:31
Core Viewpoint - Erayak Power Solution Group Inc. has entered into a securities purchase agreement for the sale of 107,692,307 shares at a price of $0.065 per share, aiming to raise approximately $7 million in gross proceeds [1][2]. Group 1: Offering Details - The offering involves the purchase and sale of Class A ordinary shares or pre-funded warrants, with a purchase price of $0.065 per share [1]. - The transaction is expected to close on or about August 1, 2025, pending customary closing conditions [2]. - Craft Capital Management is acting as the sole placement agent for this offering [2]. Group 2: Regulatory Information - The offering is conducted under a shelf registration statement on Form F-3, which was declared effective by the SEC on May 16, 2024 [3]. - A prospectus supplement detailing the terms of the offering will be filed with the SEC prior to closing [4]. Group 3: Company Overview - Erayak specializes in manufacturing, research and development, and wholesale and retail of power solution products, including inverters, generators, and smart chargers [6]. - The company's products are primarily used in agricultural and industrial vehicles, recreational vehicles, and outdoor living products [6].
Gray Media Names Eric Walters as General Manager of KNOE and KAQY in Monroe, Louisiana
Globenewswire· 2025-07-31 18:30
ATLANTA, July 31, 2025 (GLOBE NEWSWIRE) -- Gray Media has named Eric Walters as the next General Manager of KNOE and KAQY-LD, Gray’s CBS and ABC affiliates in Monroe, Louisiana, effective September 1, 2025. Eric is currently General Manager of KMVT (CBS) and KSVT-LD (FOX) in Twin Falls, Idaho. During his tenure, he worked with station leaders to grow ratings in all newscasts and to significantly increase digital content across all platforms. Eric previously served as the News Director of Gray’s WDBJ (CBS ...
Campine’s agile navigation through the trade war effects
Globenewswire· 2025-07-31 18:30
Beerse, Belgium – July 31, 2025 – 20:30 CET Campine NV, metals recycling and specialty chemicals company from Beerse, Belgium and listed on Euronext Brussels, navigates in an agile way through the different effects of trade wars. Following the U.S. administration’s announcement on April 2nd, 2025, of new import tariffs for European products, Campine received official confirmation that its antimony trioxide (ATO) is exempt from these duties. This contrasts sharply with the 15% tariffs now applied to most oth ...
GRI Bio CEO, Marc Hertz, Participates in Virtual Investor “What This Means” Segment
Globenewswire· 2025-07-31 17:50
Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [3] - The company is in the clinical stage and aims to fundamentally change treatment approaches for these diseases [3] Recent Developments - GRI Bio participated in a Virtual Investor segment where CEO Marc Hertz discussed interim biomarker data from a Phase 2a study in Idiopathic Pulmonary Fibrosis (IPF) [2] - The interim data was collected over a 6-week period, indicating progress in the ongoing study [2] Product Pipeline - GRI Bio's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as an oral therapeutic for IPF, which has significant unmet medical needs [3] - The company is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists aimed at treating systemic lupus erythematosus [3] - GRI Bio possesses a library of over 500 proprietary compounds, which supports the expansion of its product pipeline [3]
LLYC grows recurring EBITDA by 15% in H1, reaching €7.9 million
Globenewswire· 2025-07-31 17:38
Total income rose nearly 19% to €64.8 million, while operating income grew by 6.1% to €45.8 millionThe Marketing and Corporate Affairs firm updates its financial guidance for 2025LLYC remains focused on growth and protecting profitability amid global uncertainty and delayed investments MADRID, July 31, 2025 (GLOBE NEWSWIRE) -- LLYC (BME:LLYC) closed the first half of 2025 with a 15% increase in recurring EBITDA, reaching €7.9 million. According to the preliminary results — pending final audit — the Marketin ...
Viridien: 2025 Interim Financial Report available
Globenewswire· 2025-07-31 17:17
Viridien Société Anonyme with a share capital of €7,180,449Registered office: 27 avenue Carnot, 91300 MassyNo.: 969 202 241 – RCS Evry 2025 Interim Financial Report available Paris, France – July 31, 2025 Viridien announced that its interim financial report as at June 30, 2025 was filed today with the Autorité des Marchés Financiers (AMF). This document is available on the Company’s website: https://www.viridiengroup.com/ under the Investors section (both in “Regulated information” and “Results and Publicat ...
RCI Banque: ‘’2025 First Half Business Report is now available’’
Globenewswire· 2025-07-31 16:30
July 31st, 2025 RCI Banque: ‘’2025 First Half Business Report is now available’’ The RCI Banque group ‘’2025 First Half Business Report’’ is now available on the Mobilize Financial Services website www.mobilize-fs.com Attachment Press Release - Report activity 2024 ...