Roche launches the cobas MPX-E assay, a new 4-in-1 donor screening test to further safeguard the global blood supply
Globenewswire· 2026-03-30 05:00
Core Viewpoint - Roche has launched the cobas® MPX-E assay, a qualitative in-vitro test for the simultaneous detection of HIV, Hepatitis C, B, and E viruses, enhancing donor screening and laboratory efficiency [1][2][8] Group 1: Product Features and Benefits - The cobas MPX-E assay consolidates the detection of four major viral targets into a single workflow, improving laboratory operations and patient safety [1][8] - The assay features dual-target detection for HIV-1 group M, enhancing sensitivity and reliability even with viral mutations [3] - It allows for flexible testing options, enabling laboratories to test for all four targets or select specific ones based on their needs [5][8] - The assay runs on the fully automated cobas x800 systems, which are capable of conducting over 10 million tests per month [4][8] Group 2: Market Context and Impact - Nucleic Acid Testing (NAT) blood screening is valued at approximately 800 million CHF globally, with a projected Compound Annual Growth Rate of +2% from 2024 to 2029 [3] - Hepatitis E (HEV) accounts for an estimated 20 million infections and 70,000 deaths annually, highlighting the importance of robust screening to manage blood supply risks [2] - The cobas MPX-E assay provides faster turnaround times and a cost-effective solution for laboratories implementing HEV screening without needing additional space or instrumentation [6][8]
Camila Japur joins Tecan as Chief Financial Officer
Globenewswire· 2026-03-30 05:00
Core Viewpoint - Tecan Group has appointed Camila Japur as Chief Financial Officer, effective June 1, 2026, to enhance financial operations and drive growth opportunities [1][3]. Group 1: Appointment Details - Camila Japur will join Tecan as CFO on June 1, 2026 [1]. - She currently serves as Group CFO of u-blox, where she has led transformation initiatives and improved financial processes [2]. - Prior to u-blox, she spent 24 years at Ericsson, including seven years as CFO for the Enterprise Segment [2]. Group 2: Leadership Perspective - Monica Manotas, CEO of Tecan, expressed enthusiasm for Camila's arrival, highlighting the importance of her role in future-proofing the company and driving sustainable profitability [3]. - Camila is recognized for her excellent track record in leading global finance operations and transformations at public companies [3]. Group 3: Company Overview - Tecan is a global leader in laboratory automation, improving healthcare innovation from life science to clinical applications [3]. - The company was founded in Switzerland in 1980 and has over 3,000 employees, with operations in Europe, North America, and Asia [3]. - In 2025, Tecan generated sales of CHF 883 million (approximately USD 1,063 million) [3].
TGS Announces AWS as its Preferred Cloud Provider
Globenewswire· 2026-03-30 05:00
Core Insights - TGS has entered a multi-year strategic agreement with Amazon Web Services (AWS) to leverage cloud computing and Generative AI for transforming energy exploration and resource extraction [1][4] - The collaboration aims to accelerate time-to-insight and reduce exploration uncertainty for TGS' customers, marking a significant shift in geoscience [1][3] TGS and AWS Collaboration - TGS is modernizing its seismic imaging and analytics by utilizing AWS's high-performance computing (HPC) and Generative AI, aiming to exceed current industry performance [2] - The partnership includes the migration of TGS Data Verse, the largest subsurface seismic library, to AWS, enabling the creation of an exploration-ready atlas of the subsurface [3] - TGS is deploying a multi-modal Subsurface Foundation Model (SFM) on Amazon Bedrock, which will process diverse data types for a comprehensive subsurface understanding [3] Technological Advancements - TGS is utilizing Amazon Elastic Compute Cloud (EC2) to execute highly parallelized workloads, scaling to millions of CPUs for rapid turnaround on complex deliverables [2] - The use of NVIDIA instances and specialized AWS hardware accelerators allows TGS to deliver high-definition seismic imaging and petabyte-scale data on demand [2] Industry Impact - The partnership is expected to unlock greater value from seismic data for energy companies, optimizing exploration workflows and enabling more confident decision-making [4] - TGS has already migrated petabytes of data to AWS, demonstrating the scale and commitment of this strategic relationship [4]
Idorsia’s daridorexant delivers outstanding results in a Phase 2 study in children with insomnia disorder
Globenewswire· 2026-03-30 05:00
Core Insights - Idorsia Ltd announces positive top-line results from its Phase 2 dose-finding study of daridorexant in pediatric patients with insomnia disorder, demonstrating a statistically significant dose-dependent improvement in total sleep time [2][4][10] Study Overview - The Phase 2 study aimed to characterize the dose-response relationship of daridorexant on total sleep time using polysomnography, with 165 patients randomized to receive either daridorexant (10, 25, or 50 mg) or placebo for two weeks [4][10] - The study included children aged 10 to 17 years, with 21% aged 10-11 years and 79% aged 12-17 years, including those with neurodevelopmental disorders like Autism Spectrum Disorder and ADHD [5][10] Safety and Tolerability - The study confirmed the excellent safety and tolerability profile of daridorexant in pediatric patients, with no adverse events indicating drug abuse and no withdrawal symptoms upon discontinuation [6][10][11] - Even at the highest tested dose of 50 mg, daridorexant's safety profile was similar to that of placebo, with no residual sleepiness reported [11] Implications for Neurodevelopmental Disorders - Results suggest that orexin signaling may play a broader role in children with neurodevelopmental disorders, potentially opening new therapeutic avenues [7][12] - The findings are particularly significant given the lack of FDA-approved medications for pediatric insomnia and the safety concerns associated with off-label drug use [9][11] Next Steps - Idorsia plans to engage with health authorities to discuss the next steps in pediatric insomnia and explore the potential of daridorexant for children with neurodevelopmental disorders [10][12] - Detailed results will be shared at upcoming congresses and in peer-reviewed publications [13]
Alkane Executes $110 Million Revolving Credit Facility
Globenewswire· 2026-03-29 22:16
Core Viewpoint - Alkane Resources Limited has secured a A$110 million Revolving Credit Facility and a A$40 million Contingent Instrument Facility to enhance liquidity and broaden banking relationships [1][2]. Financial Overview - The company repaid a $45 million project finance facility in August 2025, which has led to the execution of the new credit facilities [2]. - As of December 2025, Alkane reported $232 million in cash and bullion, indicating strong financial health [3]. Facility Details - The Revolving Credit Facility (RCF) is for general corporate purposes and is structured under a syndicated facilities agreement with major Australian banks [2][5]. - The RCF has a tenor of 3 years with options for two one-year extensions, subject to lender approval [5]. - The Contingent Instrument Facility (CIF) allows for cash backing performance guarantees to be returned to the company [2][3]. Operational Performance - Alkane's operations are performing strongly, with an upcoming production update expected for the March 2026 quarter [3]. - The company has three operating mines in Australia and Sweden, with ongoing exploration to enhance resource growth [7]. Strategic Positioning - The new facilities will enable Alkane to act quickly on emerging opportunities and strengthen relationships with tier-1 banks [3]. - The company is focused on developing organic growth projects across its operations [3].
Autozi Internet Technology (Global) Ltd. Receives NASDAQ Notification Regarding Minimum Market Value of Listed Securities
Globenewswire· 2026-03-29 14:00
Core Viewpoint - Autozi Internet Technology (Global) Ltd. has received a notification from Nasdaq indicating non-compliance with the minimum Market Value of Listed Securities (MVLS) requirement of US$50 million, with a compliance period of 180 days to rectify this issue [1]. Group 1: Company Overview - Autozi is a leading and rapidly growing lifecycle automotive service and supply-chain technology platform in China, founded in 2010 [2]. - The company provides a wide range of high-quality and cost-effective automotive products and services through both online and offline channels across the country [2]. - Autozi utilizes an advanced supply chain cloud platform and SaaS solutions to create an integrated ecosystem that enhances collaboration and efficiency within the automotive industry [2]. Group 2: Nasdaq Compliance Notification - The notification from Nasdaq, dated March 25, 2026, states that Autozi's MVLS has not met the minimum requirement for 30 consecutive business days from February 10, 2026, to March 24, 2026 [1]. - The company has until September 21, 2026, to regain compliance by achieving an MVLS of US$50 million or more for at least ten consecutive business days [1]. - If compliance is not achieved by the end of the compliance period, Autozi will receive a notification regarding the potential delisting of its securities, although the current notification does not affect the listing and trading of its securities [1].
Novartis IgAN data in New England Journal of Medicine show Fabhalta® slowed kidney function decline by 49.3%
Globenewswire· 2026-03-29 05:15
Core Insights - Novartis announced final two-year results from the Phase III APPLAUSE-IgAN study of Fabhalta (iptacopan), showing significant improvement in kidney function compared to placebo [1][4][6] Efficacy Results - Fabhalta demonstrated a 49.3% slower decline in estimated glomerular filtration rate (eGFR) slope at –3.10 mL/min/1.73 m²/yr compared to –6.12 mL/min/1.73 m²/yr for placebo [4] - The likelihood of composite kidney failure events was reduced by 43%, with 21.4% of Fabhalta patients experiencing such events compared to 33.5% in the placebo group [4][15] - 40.7% of patients on Fabhalta achieved the target for proteinuria reduction, compared to 23.7% in the placebo group [4] Safety Profile - The safety profile of Fabhalta was consistent with previous findings, showing low rates of adverse events and treatment discontinuation similar to placebo [5][10] Regulatory Status - Fabhalta received accelerated approval in the U.S. and China for proteinuria reduction in adults with IgAN and has been submitted for traditional approval to the U.S. FDA [6][15] Company Commitment - Novartis is focused on advancing treatment options for kidney diseases, aiming to address significant unmet needs and improve patient outcomes [12][13]
New England Journal of Medicine Publishes Positive Phase 3 VALOR Trial Results of Brepocitinib in Dermatomyositis
Globenewswire· 2026-03-28 19:00
Core Insights - Priovant Therapeutics announced positive results from the Phase 3 VALOR trial for brepocitinib in dermatomyositis, published in the New England Journal of Medicine, indicating significant clinical improvements and potential for practice change in treatment [1][4]. Study Results - The VALOR trial enrolled 241 patients across 90 sites globally, achieving its primary endpoint with brepocitinib 30 mg showing a 15.3-point greater improvement in the Total Improvement Score (TIS) at Week 52 compared to placebo (P<0.001) [2][7]. - Brepocitinib 30 mg demonstrated statistically significant improvements across all nine key secondary endpoints, with effects observable as early as Week 4 and sustained through Week 52 [2][7]. - More than two-thirds of patients on brepocitinib 30 mg achieved a TIS40, which is twice the minimum clinically important difference, while over half reduced systemic corticosteroid use to ≤2.5 mg/day [7]. Safety and Tolerability - Serious infections were more common in the brepocitinib 30 mg group compared to placebo, but these events were manageable, and treatment was completed in most cases [3][8]. - Adverse events leading to treatment discontinuation were more frequent in the placebo group, as were malignancies and cardiovascular events, suggesting that these may reflect the baseline risks associated with dermatomyositis [3][8]. Regulatory Status - The U.S. FDA has granted Priority Review for brepocitinib's New Drug Application (NDA), with a target action date set for the third quarter of 2026 [5][9]. Additional Findings - Analyses presented at the 2026 American Academy of Dermatology Meeting highlighted rapid and statistically significant reductions in itch and improvements in skin-related quality of life for patients treated with brepocitinib [5][6]. - Among patients with moderate-to-severe skin disease at baseline, brepocitinib 30 mg was associated with a 26.6% higher rate of functional skin remission compared to placebo [6]. Company Overview - Priovant Therapeutics focuses on developing novel therapies for autoimmune diseases, with brepocitinib being a first-in-class selective inhibitor of TYK2 and JAK1, targeting key cytokines linked to autoimmunity [10]. - The company is also evaluating brepocitinib in other conditions, including non-infectious uveitis and cutaneous sarcoidosis, with ongoing clinical trials [10]. Parent Company - Roivant is the parent company of Priovant Therapeutics, aiming to accelerate the development and commercialization of impactful medicines across various autoimmune indications [11].
MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting
Globenewswire· 2026-03-28 19:00
Core Insights - MoonLake Immunotherapeutics announced long-term Week 40 results from the Phase 3 VELA-1 and VELA-2 clinical trials for sonelokimab (SLK) in patients with moderate-to-severe hidradenitis suppurativa (HS) [1][6] Group 1: Clinical Trial Results - The Phase 3 VELA program's primary endpoint was HiSCR 75, indicating a 75% reduction in abscess and inflammatory nodule count, with 838 patients enrolled across both trials [2][24] - At Week 40, 62% of patients treated with SLK achieved HiSCR75 response, and up to 32% achieved HiSCR100 response, demonstrating significant clinical efficacy [3][6] - Secondary endpoints showed that up to 77% of patients achieved an IHS-4 55 response, and 25% achieved inflammatory remission at Week 40 [3][6] Group 2: Quality of Life Improvements - Patients treated with SLK exhibited significant improvements in quality of life, with HiSQOL scores improving by -11.8 in VELA-1 and -12.4 in VELA-2 from baseline [5][6] - At baseline, 59% of patients were categorized as "very severe" on the HiSQOL severity score, which improved to 63% in the "mild / none" category by Week 40 [5][6] - Improvements in specific HiSQOL items ranged from 41% for pain to 62% for feelings of being down or depressed [5][6] Group 3: Safety Profile - The safety profile of SLK remained consistent over time, with no new safety signals detected in the VELA trials [8][6] - Discontinuation rates were low compared to other pivotal HS trials, indicating a favorable safety and tolerability profile [2][6] Group 4: Future Directions - Following Week 52, patients will have the option to switch into a two-year open-label extension trial, indicating ongoing commitment to long-term treatment evaluation [2][6] - Upcoming milestones include the submission of a Biologics License Application (BLA) for HS in H2 2026 and primary endpoint readouts for the Phase 3 IZAR trials in psoriatic arthritis [16][6]
Biogen Announces Second Positive Phase 2 Litifilimab Trial in Cutaneous Lupus Erythematosus at 2026 American Academy of Dermatology Annual Meeting, Showing a Significant Reduction in Skin Disease Activity
Globenewswire· 2026-03-28 19:00
Core Insights - Biogen Inc. announced positive results from the Phase 2 part of the AMETHYST study for litifilimab, a monoclonal antibody targeting cutaneous lupus erythematosus (CLE), potentially marking the first new therapy for CLE in 70 years [1][5][12] Study Results - The AMETHYST Phase 2 study demonstrated a statistically significant 11.8% higher reduction in disease activity at Week 16 for litifilimab compared to placebo, with a reduction of 14.7% versus 2.9% [4][6] - Secondary endpoints showed rapid improvement in skin disease activity, with separation from placebo observed as early as Week 4, and a CLASI-50 response of 40.8% for litifilimab versus 21% for placebo at Week 24 [4][5] - The study enrolled a diverse population, with 74% of participants being women and 33% non-white, reflecting the epidemiology of CLE [3][4] Safety Profile - Litifilimab was generally well tolerated, with adverse events reported in 74.6% of participants receiving litifilimab and 64.7% in the placebo group, mostly mild to moderate in severity [7][8] - Serious adverse events occurred in 6.8% of litifilimab participants compared to 2.9% in the placebo group [7] Market Context - Currently, there are no approved targeted therapies for CLE, with the last drug approved in the 1950s, highlighting a significant unmet need in the market [12][8] - The positive results from the AMETHYST study, alongside the FDA Breakthrough Therapy Designation, position litifilimab as a potential first-in-class treatment for CLE [2][5]