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Day: September 18, 2025

Zevra Therapeutics Announces Upcoming Oral Presentation at the International Niemann-Pick Disease Alliance (INPDA) Meeting and Poster Presentations at the Child Neurology Society (CNS) Conference on MIPLYFFA® (arimoclomol) and OLPRUVA® (sodium phenylbutyrate)

MIPLYFFA, the only therapy for Niemann-Pick disease type C (NPC) shown to stop disease progression at 12 months, has been administered to more than 270 patients, representing the largest data set of NPC clinical trial patients OLPRUVA offers the established efficacy and safety of sodium phenylbutyrate in a novel and convenient formulation for the treatment of certain urea cycle disorders CELEBRATION, Fla., Sept. 18, 2025 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced an upcoming oral presentation at the International Niemann-Pick Disease Alliance (INPDA) Face-to-Face Meeting and several poster presentations at the Child Neurology Society (CNS) Annual Meeting, which will be reviewing...

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Minovia Therapeutics Receives FDA Fast Track Designation for MNV-201 in Myelodysplastic Syndrome

Regulatory Milestone Underscores Continued Promise of First-in-Class Mitochondrial Cell Therapy HAIFA, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age-related decline, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the Company’s lead investigational compound, MNV-201 for Myelodysplastic Syndrome (MDS), a serious age-related hematopoietic disease. This designation is in addition to the existing FDA Fast Track and Rare Pediatric Disease Designations for MNV-201 in the treatment of Pearson Syndrome, an ultra-rare and life-threatening mitochondrial disorder affecting children and for which the Company is currently conducting...

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N2OFF Provides Business Update on Successful Execution of Solar and Energy Storage Initiatives Across Europe

Neve Yarak, Israel, Sept. 18, 2025 (GLOBE NEWSWIRE) — N2OFF, Inc. (NASDAQ: NITO) (“N2OFF” and the “Company”), a cleantech company investing in solar energy assets based on the RTB (Ready to Build) business model, recently announced significant progress in its solar and energy storage initiatives, highlighting the successful execution of key projects in Germany, Italy, and Poland. Through its strategic partnership with Solterra Renewable Energy Ltd. (“Solterra”), N2OFF is advancing a robust portfolio of renewable energy projects, reinforcing its commitment to driving the global clean energy transition. Key Solar and Energy Storage ProjectsMelz Solar PV Project – Germany (111 MWp)Description: A flagship 115 MWp solar photovoltaic (PV) project in Melz, Germany, developed in collaboration with Solterra Renewable Energy Ltd. Current...

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Gain Therapeutics Begins Its GT-02287 Phase 1b Extension Study in People with Parkinson’s Disease

Extension of the Phase 1b study will allow participants to continue dosing with GT-02287 for an additional nine months after completing the first 90-day dosing schedule The Phase 1b study enrolled 21 subjects and the last participants will complete 90 days of dosing in December 2025 Early results from the Phase 1b study to be presented at the International Congress of Parkinson’s Disease (PD) and Movement Disorders in October BETHESDA, Md., Sept. 18, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the start of the Phase 1b extension study allowing participants to continue treatment for an additional nine months. More than half of the...

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Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates

Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs) ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders.CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced the company has entered into a definitive agreement to acquire Massachusetts-based Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx™, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides (ASOs). ThecaFlex DRx™ is designed to provide an alternative to repeat...

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Informativ Acquires Carmatic to Provide Transaction-Ready Offers Across the Automotive Ecosystem

FRISCO, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) — Informativ, a provider of fraud prevention, compliance, and credit technology for the automotive and consumer finance industries, today announced its acquisition of Carmatic, the intelligent Payments-as-a-Service platform built to deliver real-time, transaction-ready loan and lease payments. Informativ is backed by Capstreet, a Houston-based lower middle market private equity firm. Carmatic’s proprietary payment engine powers marketing platforms, desking tools, dealer websites, and digital retail providers to deliver accurate, fundable offers at the VIN level. By synchronizing inventory with lender programs, bank rates, and regional incentives in real time, Carmatic enables personalized deal structures designed to drive higher profitability for dealers and transparent financing options...

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KommuneKredit announces Interim Report for first half 2025

Summary • Profit before value adjustments and tax came to DKK 338 million, up by DKK 108 million on the year-earlier period. The increase was mainly attributable to the sale of our properties at Kultorvet 14 and 16. • Comprehensive income came to DKK -139 million for the period compared to DKK -212 million for the same period last year. • Net interest and fee income was DKK 439 million for H1 2025, an increase of DKK 110 million on the year-earlier period. • The value of total loans and leases was up by DKK 4.5 billion on end-2024 to DKK 198,588 billion at end-H1 2025. • Common Equity Tier 1 (CET1) capital, which corresponds to equity, declined from 10,188 million at end-2024 to DKK 10,004 million. For more than 125 years, KommuneKredit has provided funding to municipalities and regions in Denmark through the issuance of bonds in the international...

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Julong Holding Limited to Report First Half of Fiscal Year 2025 Financial Results on Thursday, September 25, 2025

BEIJING, Sept. 18, 2025 (GLOBE NEWSWIRE) — Julong Holding Limited (“Julong” or the “Company”) (Nasdaq: JLHL), a growth-oriented provider of intelligent integrated solutions, today announced that it will report its first half of fiscal year 2025 unaudited financial results, on Thursday, September 25, 2025, before the open of U.S. markets. The Company’s management will host an earnings conference call at 7:00 a.m. U.S. Eastern Time on September 25, 2025 (7:00 p.m. Beijing/Hong Kong Time on September 25, 2025). For participants who wish to join the call by phone, please access the link provided below to complete the pre-registration and dial in 5 minutes prior to the scheduled call start time. Upon registration, each participant will receive dial-in details to join the conference call.Event Title: Julong Holding Limited First Half...

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Osisko Gaspé Expansion Hole Intersects 133.7 Metres Averaging 1.04% Cu

Infill Hole Returns 1091.5 Metres Averaging 0.20% Cu, 1.52 g/t Ag, 0.02% Mo (0.28% CuEq) MONTREAL, Sept. 18, 2025 (GLOBE NEWSWIRE) — Osisko Metals Incorporated (the “Company” or “Osisko Metals“) (TSX: OM; OTCQX: OMZNF; FRANKFURT: 0B51) is pleased to announce new drill results from the Gaspé Copper Project, located in the Gaspé Peninsula of Eastern Québec. Osisko Metals CEO Robert Wares commented: “The growth potential of the Gaspé Copper deposit continues to be demonstrated with today’s new high-grade results. Holes 30-1106 and 30-1109 reveal the presence of a thick, higher grade tabular zone lying at depth around the E Zone horizon near the eastern margin of our 2024 MRE model. This tabular zone may extend significantly to the east if it correlates to historical drilling results. Our expansion drilling is exceeding...

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FactSet Reports Results for Fourth Quarter and Fiscal 2025

Q4 GAAP revenues of $596.9 million, up 6.2% from Q4 2024. For fiscal 2025, GAAP revenues were $2,321.7 million, up 5.4% year over year. Organic ASV was $2,370.9 million at August 31, 2025, up 5.7% year over year. Q4 GAAP operating margin of 29.7%, up approximately 700 bps year over year, and Q4 adjusted operating margin of 33.8%, down 200 bps year over year. For fiscal 2025, GAAP operating margin was 32.2%, up approximately 40 bps year over year, and adjusted operating margin was 36.3%, down 150 bps year over year Q4 GAAP diluted EPS of $4.03, up 73.7% from the prior year, and Q4 adjusted diluted EPS of $4.05, up 8.3% year over year. For fiscal 2025, GAAP diluted EPS was $15.55, up 11.8%, and adjusted diluted EPS was $16.98, up 3.2% year over year. FactSet is providing fiscal 2026 guidance with expected organic ASV growth of 4% –...

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