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Day: March 10, 2024

United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation. “We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may...

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Euro Manganese Advances to Next Stage of Debt Funding Process with the European Investment Bank

VANCOUVER, British Columbia, March 10, 2024 (GLOBE NEWSWIRE) — Euro Manganese Inc. (TSX-V and ASX: EMN; OTCQX: EUMNF; Frankfurt: E06) (the “Company”) today announced that its Chvaletice Manganese Project (“Chvaletice” or the “Project”) is formally listed1 as under appraisal for debt financing with the European Investment Bank (“EIB”). Funding from the EIB would complement a broader funding package to support the development of the Company’s high-purity battery-grade manganese plant in the Czech Republic. HighlightsEuro Manganese’s Chvaletice Project has progressed to the formal appraisal stage for debt financing with the EIB in what was a significant milestone in securing funds for the Czech Republic’s high-purity manganese production plant Chvaletice is the European Union’s...

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Arcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting

Investigational roflumilast cream 0.05% met the primary endpoint and all secondary endpoints, showing significant improvement across multiple efficacy endpoints as early as Week 1 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint New data highlight rapid and significant reduction in itch as early as 24 hours following first application of roflumilast cream 0.05% based on daily Worst Itch Numeric Scale (WI-NRS) New data show 35.4% of children treated with roflumilast cream 0.05% achieved a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ at Week 4, with significant improvements seen as early as Week 1 Results for roflumilast cream 0.05%, show consistent efficacy and favorable safety...

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Ensurge Micropower ASA – Investor Presentation

Oslo, 10 March 2024 An updated investor presentation is attached. About Ensurge Micropower:Ensurge is Energizing Innovation (TM) with the first ultrathin, flexible, reliable, and fundamentally safe solid-state lithium microbattery for the 1 to 100 milliampere-hour (mAh) class of wearable devices, connected sensors, and beyond. The innovative Ensurge Microbattery enables energy-dense rechargeable products that are ideal for form-factor-constrained applications including hearables (hearing aids and wireless headphones), digital and health wearables, sports and fitness devices, and IoT sensor solutions that use energy harvesting to power everyday things. The company’s state-of-the-art manufacturing facility, located in the heart of Silicon Valley, combines patented process technology and materials innovation with the scale of roll-to-roll...

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MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D DayPositive 24-week data from the ARGO trial of sonelokimab in PsA: Significant improvements observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an ACR50 response at week 24 Unprecedented multi-domain responses across joints, skin and other domains, including up to 52% of patients achieving ACR50+PASI100 and up to 61% of patients achieving Minimal Disease Activity (MDA), supporting potential best-in-class profile of sonelokimab Monthly maintenance with 60mg or 120mg doses showed leading responses above TNF reference arm across all key outcomes including in higher treatment goals (ACR70, PASI100, composites) – 120mg...

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Loulo-Gounkoto Delivers Another Value-Creating Performance

All amounts expressed in US dollars LOULO, Mali, March 10, 2024 (GLOBE NEWSWIRE) — Barrick Gold Corporation (NYSE:GOLD)(TSX:ABX) – The Loulo-Gounkoto complex in Mali, one of the world’s largest gold producers, has contributed more than $1 billion to the Malian economy over the past 12 months, maintaining its long record as one of the country’s largest and most consistent revenue generators. The complex is on track to meet its production guidance for the current quarter and the year. There have been no lost time injuries or major environmental incidents during the quarter to date. Speaking to media and stakeholders at the mine today, Mark Bristow, president and chief executive of operator Barrick Gold Corporation, said the complex showed that a world-class mining business, developed by international investors but run entirely by...

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