ECB's Makhlouf Says Euro Not Ready to Challenge Dollar's Role
The Central Bank of Ireland Governor said dollar dominance will decline over the long-term, but for now Europe lacks a single fiscal capacity of a safe asset like Treasuries that would mirror the US system.
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9 minutes ago
- Yahoo
Moderna lowers top end of revenue guidance as vaccine group targets cost cuts
- Moderna has lowered the top end of its full-year revenue forecast, citing a delay in the timing of deliveries of its COVID-19 jab to the United Kingdom, presenting a fresh setback for a company already aiming to slash expenses and boost recently tepid demand. The vaccine maker said it now anticipates that annual revenue will come in at $1.5 billion to $2.2 billion, compared to a prior estimate of $1.5 billion to $2.5 billion, flagging the impact of change in the expected date of the shipments to the first quarter of its next fiscal year from the second half of 2025. Bloomberg consensus estimates had called for guidance of $2.07 billion. Shares of Moderna (NASDAQ:MRNA) sank in premarket U.S. trading. The stock has slumped by more than 29% so far this year. Friday's announcement comes after Moderna announced a sweeping headcount reduction earlier this week that will see it slash around 10% of its global staff and have less than 5,000 employees by the end of the year. Moderna has been pushing to bring down costs as it grapples with flagging sales of its once mega-popular COVID-19 vaccines. Such cost-cutting efforts helped to bring overall operating expenses for the second quarter down by 35% versus a year ago to $1.05 billion. Bancel said Moderna now expects full-year operating expenses to be between $5.9 billion to $6.1 billion, an improvement of approximately $400 million from its prior outlook. Quarterly revenue, meanwhile, dropped by 41% to $142 million, but topped expectations for $108.5 million. Moderna's loss per share of $2.13 for the period was also less than analysts had anticipated. Related articles Moderna lowers top end of revenue guidance as vaccine group targets cost cuts Risks Rising? Smart Money Dodged 46%+ Drawdowns on These High-Flying Names If Powell goes, does Fed trust go with him? Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
10 minutes ago
- Associated Press
Artelo Biosciences Receives Favorable UK MHRA Guidance for a Phase 1 Trial of ART12.11, the Company's Proprietary CBD:TMP Cocrystal Being Developed for the Treatment of Anxiety and Depression
SOLANA BEACH, Calif., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. ('Artelo' or the 'Company') (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, today announced that it has received written scientific advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the nonclinical development and first-in-human (FIH) clinical study plans for ART12.11, a novel cocrystal of Cannabidiol (CBD) and Tetramethylpyrazine (TMP). The MHRA agreed that reliance on the substantial body of historic nonclinical and clinical evidence for CBD, alongside legacy data for TMP, provides a scientifically justified basis for a streamlined clinical trial application (CTA)-enabling nonclinical development plan of the cocrystal combination to support the proposed FIH study, with clear guidance for achieving the agreed-upon FIH study design for ART12.11. The agency also affirmed that the proposed first-in-human (FIH) study design—a single-dose, multi-formulation crossover study—was methodologically sound for characterizing ART12.11's pharmacokinetic profile. Importantly, the MHRA offered constructive and specific guidance for completing the data package supporting the agreed-upon Phase 1 trial. Additionally, the agency proposed that ART12.11 may be a candidate for the Innovative Licensing and Access Pathway (ILAP). ILAP offers a unique opportunity to accelerate the development and patient access of promising new therapies through early and sustained collaboration with the MHRA, National Health Service, and health technology assessment bodies. Given ART12.11's novel mechanism and potential to address unmet needs in anxiety and depression, Artelo believes the program aligns well with ILAP's criteria and will evaluate a formal application to enter the pathway in the coming months. 'It's gratifying to receive this positive feedback and actionable recommendations from the MHRA, which provides a clear path forward as we prepare to initiate clinical studies with ART12.11,' said Dr. Andrew Yates, Chief Scientific Officer at Artelo. 'The recommendation to explore ILAP reinforces the proposition of ART12.11 as a novel drug with the potential to transform the treatment landscape for anxiety and depression.' Multiple nonclinical studies with ART12.11 have shown its promising profile compared to an antidepressant or CBD alone. The Company recently announced positive preclinical results in a depression model comparing ART12.11 with sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), where Artelo's patented CBD:TMP cocrystal demonstrated efficacy on par with sertraline and showed superior cognitive restoration compared to the leading SSRI. Additionally, in a rodent model of stress-induced anxiety and depression, where ART12.11 was compared to CBD dosed at 300% the amount of CBD contained in the oral tablet of ART12.11, the CBD:TMP cocrystal demonstrated efficacy where CBD alone did not. 'The clear regulatory assurance from the regulatory authority in the UK is expected to reduce expenses for our ART12.11 program,' added Gregory Gorgas, President & CEO at Artelo. 'We are especially pleased with the potential for an accelerated development strategy which could greatly accelerate our progress with ART12.11 and could provide for a longer period of market exclusivity as our patents are valid in 20 countries through the end of 2038. Over the next few months we look forward to finalizing our preparations to enter the clinic with ART12.11 early next year.' About ART12.11 ART12.11 is Artelo's wholly owned, proprietary cocrystal composition of cannabidiol (CBD) and tetramethylpyrazine (TMP). Isolated as a single crystalline form, ART12.11 has exhibited better pharmacokinetics and improved efficacy compared to other forms of CBD in nonclinical studies. Greatly enhanced pharmaceutical properties, including physicochemical, pharmacokinetic, and pharmacodynamic advantages have been observed with ART12.11. Artelo believes a more consistent and improved bioavailability profile in a solid dosage form may ultimately lead to increased safety and efficacy in humans, thus making ART12.11 a preferred CBD pharmaceutical composition. The U.S. issued composition of matter patent for ART12.11 is enforceable until December 10, 2038, and has now been granted or validated in 19 additional countries. About Artelo Biosciences Artelo Biosciences, Inc. is a clinical stage pharmaceutical company dedicated to the development and commercialization of proprietary therapeutics that modulate lipid-signaling pathways. Artelo is advancing a portfolio of broadly applicable product candidates designed to address significant unmet needs in multiple diseases and conditions, including anorexia, cancer, anxiety, dermatologic conditions, pain, and inflammation. Led by proven biopharmaceutical executives collaborating with highly respected researchers and technology experts, the Company applies leading edge scientific, regulatory, and commercial discipline to develop high-impact therapies. More information is available at and Twitter: @ArteloBio. Forward Looking Statements Investor Relations Contact: Crescendo Communications, LLC Tel: 212-671-1020 Email: [email protected]
Bloomberg
11 minutes ago
- Bloomberg
Why French Elites Are Seeing the US Tariffs Deal as a Surrender
Bonjour et Bienvenue to the Paris Edition. I'm Bloomberg Opinion columnist Lionel Laurent. If you haven't yet, subscribe now to the Paris Edition newsletter. Humiliation, surrender, defeat – the European Union has come under criticism across the continent for its tariff 'deal' with the Trump administration. Yet it's in France that the anger has come closest to becoming official government policy, with Prime Minister Francois Bayrou describing it as 'submission' in a post on X and calling it 'a dark day.'
