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Day: January 9, 2023

AMG Advanced Metallurgical Group N.V. Announces Approval for Vanadium Electrolyte Plant at AMG Titanium

Amsterdam, 9 January 2022 — AMG Advanced Metallurgical Group N.V. (“AMG”, EURONEXT AMSTERDAM: “AMG”) announces the Management Board has approved to build a Vanadium Electrolyte plant at its subsidiary, AMG Titanium, in Nuremberg, Germany. The target capacity is 6,000 m³ vanadium electrolyte. Basic engineering for the plant was completed in November, with production expected to start at the end of 2023. Given the outlook for the vanadium redox flow battery market, AMG Titanium’s technological expertise in producing highly purified Vanadium products, and AMG LIVA’s raw material requirements for the battery Hybrid Energy Storage Systems (“HESS”), this expansion is a vital strategic investment for AMG and will strengthen AMG’s strategy to enable energy efficiency and CO2 reduction for its customers in industrial operations. About AMG AMG...

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Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD) for filing. The FDA has set October 26, 2023, as the Prescription Drug User Fee Act (PDUFA) target action date. The PDUFA date is the target date for the FDA to complete its review of the NDA. Furthermore, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss the application. Subject to approval, Santhera plans to launch vamorolone in the U.S. in Q4-2023. “We are delighted that the FDA has accepted Santhera’s vamorolone NDA for filing. We believe this product...

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Dassault Systèmes Governance Plan Announced in 2022 Now Effective

Press Release VELIZY-VILLACOUBLAY, France — January 9, 2023 Dassault Systèmes Governance Plan Announced in 2022 Now Effective Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) announces that the governance organization carefully crafted over years and aligned with the company long term strategy, as communicated on April 27, 2022, is effective today:Charles Edelstenne, Founder, is handing over his position as Chairman of the Board of Directors, remains Director and becomes Honorary Chairman. Bernard Charlès, Vice Chairman of the Board of Directors and Chief Executive Officer, becomes Chairman and Chief Executive Officer. Pascal Daloz, Chief Operating Officer, is also appointed Deputy Chief Executive Officer. Daloz is member of the Board of Directors.Laurence Daures (formerly Lescourret), an independent Director and Chair of...

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argenx Highlights 2023 Strategic Priorities Across Immunology Pipeline

Reported $402 million in preliminary* full-year 2022 global net VYVGART sales ADHERE topline results now expected in second quarter of 2023; Stage B enrollment has surpassed projected target of 130 patients Registrational trial of efgartigimod in thyroid eye disease (TED) to start in 2023; additional proof-of-concept trials to start in ANCA-associated vasculitis and antibody mediated rejection (AMR) Submission for marketing approval in Japan of VYVGART for immune thrombocytopenia (ITP) expected in mid-2023 Amsterdam, the Netherlands – January 9, 2022 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its strategic priorities for 2023 and provided preliminary financial results for the full year 2022, including global...

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Idorsia presents at the 41st J.P. Morgan Healthcare Conference – Achievements in 2022 provide the foundation for our success in 2023

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – January 9, 2023 Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive Officer of Idorsia, will present at the 41st J.P. Morgan Healthcare Conference on January 9, 2023, at 17:15 Pacific Standard Time / 02:15 Central European Time. The conference will take place at the Westin St. Francis hotel in San Francisco, USA. Jean-Paul will describe how Idorsia is building momentum to become a leading mid-sized biopharmaceutical company. The presentation will cover the launch of the company’s first products, PIVLAZ™ (clazosentan) in Japan and QUVIVIQ™ (daridorexant) in the US and Europe. He will also present opportunities for future growth coming from the clinical development pipeline, including the recent filing of a new drug application for...

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TGS Q4 2022 Revenue Update

OSLO, Norway (9 January 2023) – Based on preliminary reporting from operating units, management of TGS ASA (“TGS”) expects revenues (excluding contribution from Magseis Fairfield ASA) for Q4 2022 to be approximately USD 164 million, compared to USD 105 million in Q4 2021. POC revenues* are expected to be approximately USD 172 million, up from USD 120 million in Q4 2021. Late sales accounted for approximately USD 136 million, 157% above the USD 53 million reported for Q4 2021. Kristian Johansen, CEO at TGS, commented: “I’m pleased to see that the strong momentum in sales accelerated in the quarter. Late sales in Q4 2022 are the best fourth-quarter late sales since 2014. In addition, we have seen solid growth in order inflow related to new investments lately, meaning that the multi-client backlog increased significantly in the quarter” TGS...

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Spexis reports solid safety and pharmacokinetics results from first-in-human study with inhaled murepavadin, a novel macrocycle compound

Ad hoc announcement pursuant to Art. 53 LRInhaled murepavadin shown to be well tolerated at all dose levelsProgram derived from Spexis’ macrocycle platform Data support moving forward to Phase 2 in cystic fibrosis and non-cystic fibrosis bronchiectasis lung infectionALLSCHWIL, Switzerland, Jan. 09, 2023 (GLOBE NEWSWIRE) — Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced the successful completion of the first-in-human clinical trial with novel class antibiotic murepavadin, delivered via the oral inhalation route (iMPV). iMPV is a macrocycle compound derived from Spexis’ proprietary platform and specifically targets the outer membrane of Pseudomonas aeruginosa (P. aeruginosa) including activity against highly resistant strains. P. aeruginosa is the key...

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Continued strong Cresemba® (isavuconazole) sales by Astellas in the U.S. trigger CHF 20 million sales milestone payment to Basilea

Ad hoc announcement pursuant to Art. 53 LR Basel/Allschwil, Switzerland, January 09, 2023 Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the continued strong sales of the antifungal Cresemba® (isavuconazole) achieved by its partner Astellas Pharma Inc. (“Astellas”) in the United States in 2022 exceeded the threshold triggering a milestone payment of CHF 20 million to Basilea. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued commercial success of Cresemba. This milestone reflects the strong sales growth in 2022 in the U.S. and confirms that Cresemba is addressing a high medical need and plays an important role in the treatment of patients suffering...

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Proactive news headlines including Tempus Resources, Australian Strategic Materials, Blue Star Helium and Element 25

Sydney, Jan. 09, 2023 (GLOBE NEWSWIRE) — Proactive, provider of real-time news and video interviews on growth companies listed in Australia, has covered the following companies:Tempus Resources Ltd (ASX:TMR, TSX-V:TMRR) has fielded assay results described as “extraordinary” from the Elizabeth Gold Project in southern British Columbia with shares soaring by as much as 70.38% intraday to A$0.092 on volume of more than 50 million. Click here Australian Strategic Materials Ltd (ASX:ASM) has kicked off its engineering, procurement and construction definition work (EPCD) for the Dubbo Project in Central West New South Wales, contracted to Hyundai Engineering Co., Ltd (HEC), one of the world’s leading EPC firms. Click here Blue Star Helium Ltd (ASX:BNL, OTC:BSNLF) has received the final approvals from the Colorado Oil and Gas Conservation...

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Vital Energy Completes Rebranding

Fourth-Quarter 2022 Production Expected to Exceed Guidance TULSA, OK, Jan. 08, 2023 (GLOBE NEWSWIRE) — Vital Energy, Inc. (NYSE: VTLE) (“Vital” or the “Company”) today announced the completion of the Company’s rebranding and on Monday, January 9, 2023, will begin trading under the ticker “VTLE” on the NYSE. The Company’s new website is www.vitalenergy.com. Additionally, Vital updated its outlook for fourth-quarter 2022 production and incurred capital expenditures. Fourth-Quarter 2022 Production and Incurred Capital Expenditure OutlookOil production is expected to be approximately 35.5 thousand barrels of oil per day (“MBO/D”), exceeding guidance of 32.0 – 34.0 MBO/D Total production is expected to be approximately 77.5 thousand barrels of oil equivalent per day (“MBOE/D”),...

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