BeOne Medicines And 2 Stocks That May Be Undervalued By The Market

NXP and Rimac Technology Co-Develop Centralized Vehicle Architecture for Advanced Domain and Zonal Control

Yahoo

23 minutes ago

Yahoo

NXP and Rimac Technology Co-Develop Centralized Vehicle Architecture for Advanced Domain and Zonal Control

NXP and Rimac Technology Co-Develop Centralized Vehicle Architecture for Advanced Domain and Zonal Control Rimac Technology is the first to deploy NXP's S32E2 real-time processor series in its upcoming next-generation ECU platform for software-defined vehicles (SDV) NXP and Rimac's jointly developed centralized architecture consolidates more than 20 electronic control units into just three centralized units Collaboration enables OEMs to adopt SDV architectures with advanced domain and zonal control applications EINDHOVEN, The Netherlands, June 12, 2025 (GLOBE NEWSWIRE) -- NXP Semiconductors N.V. (NASDAQ: NXPI), the worldwide leader in automotive processing, today announced its collaboration with Rimac Technology, a leading automotive industry supplier specialized in high-performance control systems, to advance centralized architectures for SDVs. The jointly developed solution features NXP's S32E2 processors, which are part of NXP's comprehensive S32 Automotive Processing Platform, designed for current and future connectivity, security and safety challenges in automotive. The S32E addresses the vehicle's need for high-performance deterministic real-time domain and zonal control in a multi-applications environment. The rapid evolution of new centralized vehicle architectures and the consolidation of electronic control units (ECUs) demand a high level of safe application integration. NXP and Rimac Technology's jointly developed architecture provides an easy-to-use platform that allows the development and efficient integration of many different vehicle applications such as vehicle dynamics and charging control, energy and thermal management, and body electronics. The S32E2, at the heart of it, allows the consolidation of over 20 ECUs into just three centralized units. The S32E is part of NXP's high performance multi-application processor range and integrates 8 Arm® Cortex®-R52 processor cores running at up to 1 GHz, high-resolution analog-to-digital converters and the capability to support large amounts of non-volatile memory, up to 64MB. 'OEMs and tier 1s have faced the challenge of either consolidating multiple applications within legacy microcontrollers or deploying excessive redundant computing power to achieve application independence', said Ray Cornyn, SVP and General Manager, Automotive Processors at NXP. 'The NXP platform allows developers to quickly implement SDV features for advanced real-time applications. The S32E2 enables the efficient integration of numerous applications within an easy-to-debug environment, where task isolation and determinism are inherent to the design.' 'The growing complexity of vehicle systems with numerous ECUs requires a solution that decreases weight, manages power consumption and simplifies software integration', said Ana Martinčić Špoljarić, Business Unit Director for Powertrain and Electronics at Rimac Technology. 'With NXP's S32E2 real-time processors, we found the ideal high-performance and automotive-grade solution that allows us to integrate several units into a single domain controller, reducing complexity and material costs for automotive OEMs while significantly increasing computational power.' The ISO 26262 ASIL D compliant S32E2 series serves the diverse automotive OEM needs by providing safe and secure high-performance processing that is essential for SDVs. Its comprehensive safety offering with core to pin isolation mechanism ensures freedom of interference and task level fault recovery throughout the device. The integrated, powerful Hardware Security Engine provides secure boot, key management and security services. Rimac Technology will primarily leverage the new ECU platform in a hyper car program, with plans to scale up in different vehicle segments and alternative mobility sectors. Find out more about the collaboration with Rimac Technology. System SolutionsThe S32E2 extends NXP's comprehensive S32 automotive processing platform and fits between the recently introduced S32K5 microcontroller family and the 5 nm S32N real-time super integration processors. Combined with NXP's networking and system power management solutions and the middleware, OSes and other software from the world's leading automotive software providers under the NXP CoreRide platform, these system solutions help automakers overcome software and hardware integration barriers, while scaling development efforts for new architectures in SDVs. S32E2 System SupportNXP offers system support for S32E2 processors to accelerate customer designs including the FS86 ASIL D safety system basis chip (SBC) and PF5030 power management IC (PMIC) with enhanced safety features and in-vehicle networking support with Ethernet switches and PHYs and CAN transceivers, along with other analog companion chips such as the GD3160 IGBT/SiC high-voltage inverter gate driver and MC3377x battery cell controllers. About NXP SemiconductorsNXP Semiconductors N.V. (NASDAQ: NXPI) is the trusted partner for innovative solutions in the automotive, industrial & IoT, mobile, and communications infrastructure markets. NXP's "Brighter Together" approach combines leading-edge technology with pioneering people to develop system solutions that make the connected world better, safer, and more secure. The company has operations in more than 30 countries and posted revenue of $12.61 billion in 2024. Find out more at NXP and the NXP logo are trademarks of NXP B.V. All other product or service names are the property of their respective owners. All rights reserved. © 2025 NXP B.V For more information, please contact: Americas and Europe Greater China / Asia Andrea Lempart Ming Yue Tel: +49 175 610 695 1 Tel: +86 21 2205 2690 Email: Email: About Rimac TechnologyRimac Technology is a Tier 1 technology supplier to the automotive industry, fully owned and operated by the Rimac Group. The company is a leading provider of electrification technologies, specializing in the engineering, development, production, and supply battery systems, electric drive units and electronic control units. Having developed the technology behind the world's fastest electric hypercar – the Nevera – Rimac Technology delivers cutting-edge solutions to some of the most prestigious OEMs globally. Based at the state-of-the-art Rimac Campus in Zagreb, the company operates a world-class R&D and production hub, manufacturing high-performance components at scale for the premium and luxury automotive markets. Headquartered in Croatia, with offices in the UK, Rimac Technology currently employs more than 1,400 people. For more information, please contact: MEDIA ENQUIRIES:press@ A photo accompanying this announcement is available at 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

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Yahoo

5 hours ago

Yahoo

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD). In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing. In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication. Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company's expectations at product launch. Mesoblast has continued to expand coverage for Ryoncil® to over 220 million US lives insured by commercial and government payers. To date, 37 of the 51 States provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process. The remainder will come online July 1, 2025, with mandatory coverage for all 24 million lives. 'We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs,' said Mesoblast Chief Executive Dr. Silviu Itescu. 'We are also encouraged by the strength of the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch. We will be providing an update on sales of Ryoncil® in our quarterly activities report at the end of next month.' About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast's RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@

Yahoo

6 hours ago

Yahoo

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD). In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval. The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing. In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product's label from children to adults with SR-aGvHD. Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication. Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company's expectations at product launch. Mesoblast has continued to expand coverage for Ryoncil® to over 220 million US lives insured by commercial and government payers. To date, 37 of the 51 States provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process. The remainder will come online July 1, 2025, with mandatory coverage for all 24 million lives. 'We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs,' said Mesoblast Chief Executive Dr. Silviu Itescu. 'We are also encouraged by the strength of the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch. We will be providing an update on sales of Ryoncil® in our quarterly activities report at the end of next month.' About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast's RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@ 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

BeOne Medicines And 2 Stocks That May Be Undervalued By The Market

Hashtags

Try Our AI Features

Comments

Related Articles

NXP and Rimac Technology Co-Develop Centralized Vehicle Architecture for Advanced Domain and Zonal Control

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

BeOne Medicines And 2 Stocks That May Be Undervalued By The Market

Hashtags

Try Our AI Features

Comments

Related Articles

NXP and Rimac Technology Co-Develop Centralized Vehicle Architecture for Advanced Domain and Zonal Control

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Mesoblast Maintains Momentum With FDA on Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure and Label Extension for Ryoncil® in Adults With GvHD

Get Started Now: Download the App