Day: November 2, 2025

Leanne Heywood was most recently a senior international copper marketing executive with Rio Tinto PERTH, Australia, Nov. 02, 2025 (GLOBE NEWSWIRE) — FireFly Metals Ltd (ASX/TSX: FFM) (FireFly or the Company) is pleased to announce the appointment of highly regarded resources executive and company director Leanne Heywood as an Independent Non-Executive Director. Ms Heywood, who is a Fellow of accounting body CPA Australia, has significant experience as an international executive in the mining sector. Most recently, she held a senior international copper marketing role with Rio Tinto Limited and, prior to that, she was Chief Financial Officer of a copper mine in the Rio Tinto portfolio. Ms Heywood currently serves as a Non-Executive Director of Deterra Royalties Limited (ASX: DRR), Snowy Hydro Limited, Lotus Resources Limited (ASX:...

Underground core drilling at Tomingley is focused on defining extensions to resources as well as improving confidence of Inferred Resources at McLeans and the Western Monzodiorite domain at Roswell. Both McLeans and the Western Monzodiorite are immediately adjacent to existing underground infrastructure.    Underground drilling comprising of 9 diamond holes for a total of 3,247 metres was completed to improve the confidence of the Inferred Resource at McLeans. This drilling discovered a second andesite with significant gold mineralisation, located approximately 150m to the west of the current resource. Significant gold intercepts hosted by the western andesite include:MCLUG013Dincl   26 metres grading 4.36 g/t Au from 112 metres;3.3 metres grading 22.8 g/t Au from 112.7 metres.MCLUG012D   10.7 metres grading 2.09 g/t Au from 105...

REYKJAVIK, Iceland, Nov. 02, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application. The facility remains FDA approved to manufacture...

REYKJAVIK, ICELAND (November 2, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi® (golimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application. The facility remains FDA approved to manufacture and continues...

BERKELEY, Calif., Nov. 02, 2025 (GLOBE NEWSWIRE) — Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it will hold a webcast beginning at 8:00 am ET on Monday, November 3, 2025, to report new data from the ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) and report the first clinical data from the CaMMouflage Phase 1 clinical trial evaluating CB-011, an allogeneic anti-BCMA CAR-T cell therapy, in patients with r/r multiple myeloma. The Company will also report its anticipated pivotal phase 3 trial design for vispa-cel and next steps for the continued clinical development of...

LUXEMBOURG, Nov. 02, 2025 (GLOBE NEWSWIRE) — Tenaris S.A. (NYSE and Mexico: TS and EXM Italy: TEN) (“Tenaris”) announced today that pursuant to its USD 1.2 billion Share Buyback Program (the “Program”) announced on May 27, 2025, it has entered into a non-discretionary buyback agreement with a primary financial institution (the “Bank”) for the execution of its second tranche, covering up to the remainder USD 600 million of the Program (excluding customary transaction fees). This second tranche shall start on November 3, 2025, and end no later than April 30, 2026. The Bank will make its trading decisions concerning the timing of the purchases of Tenaris’s ordinary shares independently of and uninfluenced by Tenaris. The Program will be executed in compliance with applicable rules and regulations, including the Market Abuse Regulation...

MHRA response is based on the Phase 3 DRAGON interim analysis results  Topline final data expected in Q4 2025SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) — Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. “We are extremely pleased with the outcome of our engagement with the MHRA. This is an incredibly exciting time for the Belite team as we see our perseverance bringing us closer to offering an...

SHENZHEN, China, Nov. 02, 2025 (GLOBE NEWSWIRE) — Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leader in AI-driven Internet healthcare solutions, was presented with a Generative AI Service Filing Certificate at the first Guangdong Provincial LLM Filing Conference in Shenzhen. At the event, Dr. Xie Fangmin, Founder, Chairman, and CEO of Fangzhou, remarked: “The successful launch of the ‘XingJie’ Large Language Model (‘XJ LLM’) marks another milestone in Fangzhou’s advancement of AI-driven chronic disease management. Building on this momentum, we will continue to optimize our models and enrich our AI+H2H (Hospital-to-Home) healthcare ecosystem, integrating frontier AI capabilities with professional medical services so that every user can experience smarter, more accessible, and more personalized care support.” Dr....