US Market News
1月前
The $59B Quiet Shift Reshaping How Patients Access CareMay 12, 2026 10:30 AM
PR Newswire (US) Issued on behalf of VentriPoint Diagnostics Ltd.Equity-Insider.com News CommentaryVANCOUVER, BC, May 12, 2026 /PRNewswire/ -- Point-of-care diagnostics just crossed $58.76 billion globally in 2026, growing at nearly 10% annually as testing that used to require a hospital lab now fits on a clinic counter or a patient's nightstand[1]. That capital rotation is real: digital health startups pulled in $4 billion in Q1 alone, the strongest first quarter since the pandemic peak, with average deal sizes at levels not seen since late 2021[2]. Investors are not chasing drug discovery this cycle; they are backing companies that can deliver clinical-grade results through faster, lighter, cheaper channels, and five names sit at the center of that structural realignment: VentriPoint Diagnostics (TSXV: VPT) (OTCPK: VPTDF), Hims & Hers Health (NYSE: HIMS), Novo Nordisk (NYSE: NVO), MannKind (NASDAQ: MNKD), and Ginkgo Bioworks (NYSE: DNA). The trajectory keeps steepening. Analysts project the global POC diagnostics market will reach $114.65 billion by 2035, fueled by AI integration, miniaturized biosensors, and cloud-connected platforms that compress turnaround times from days to minutes[3]. The entire diagnostic equipment value chain is shifting from a centralized hospital model to a decentralized, consumer-facing landscape, and that creates a scalable opening for platforms delivering accessible, clinical-grade outcomes outside traditional hospital walls.VentriPoint Diagnostics (TSXV: VPT) (OTCPK: VPTDF) is heading to Europe next week to showcase its AI-powered cardiac imaging platform at one of the biggest cardiology conferences on the planet. The company will exhibit at the 59th Annual Meeting of the Association for European Paediatric and Congenital Cardiology (AEPC), running May 12 to 16 in Padua, Italy, alongside European distributor AngioPro. AEPC is the world's largest association in congenital cardiology, with over 1,000 specialists across 32 countries, and this year's program is centered on cardiovascular imaging and artificial intelligence, exactly the areas where VentriPoint operates.VMS+™ 4.0 takes a standard 2D ultrasound scan and converts it into a detailed 3D model of the heart. The company says the results are comparable to cardiac MRI, but without the million-dollar machine or the months-long wait list. Built on more than a decade of proprietary Knowledge Based Reconstruction technology, the system works with ultrasound equipment from any manufacturer and holds regulatory approvals in the United States, Canada, and Europe.That regulatory footprint is expanding. In late April, VentriPoint announced that strategic partner Lishman Global Inc. formally submitted VMS+™ 4.0 to China's National Medical Products Administration (NMPA) for approval. Lishman Global qualified for the NMPA's expedited "green channel" review pathway, reserved for innovative technologies addressing significant clinical needs. China has an estimated 330 million patients affected by cardiovascular disease.Commercial momentum has been building. VentriPoint recently picked up a Gold Medal at the 2026 Edison Awards for VMS+™ 4.0. It announced a collaboration with the Health Division of the Montecristo Group to deploy VMS+™ across Costa Rica's hospital networks, where Hospital Metropolitano has an existing relationship with Sanford Health. VentriPoint also recently partnered with First Light Health to bring cardiac diagnostics to Indigenous and remote communities across Canada, building on an earlier partnership with the Nisga'a Valley Health Authority. The company also signed a commercial agreement with LG Consulting Solutions targeting cardiac centres in Northern California."AEPC represents the heart of the European congenital cardiology community, and we are proud to be part of it," said Hugh MacNaught, President and CEO of VentriPoint. "VMS+™ delivers fast, affordable, and accessible volumetric cardiac assessments with accuracy comparable to MRI, giving clinicians the confidence they need to manage their patients at every stage of life."With regulatory submissions advancing in China, distribution partners spanning Costa Rica to Northern California, Edison Award recognition, and a growing presence at major cardiology conferences, VentriPoint is building the kind of global footprint that turns a promising medtech platform into a scalable business.CONTINUED… Read this and more news for VentriPoint Diagnostics at: https://equity-insider.com/2025/11/21/the-mri-grade-disruption-hiding-in-plain-sight-why-the-smart-money-is-watching-ventripoint/Other industry developments and happenings in the market include:Hims & Hers Health (NYSE: HIMS) announced a new collaboration with Novo Nordisk to make a broad assortment of FDA-approved GLP-1 medications available to eligible customers, including Wegovy, the only FDA-approved GLP-1 weight loss pill. The expansion positions Hims & Hers Health as the largest global consumer health platform for affordable access to approved medications, with prices starting as low as $149 a month."Today we're taking an important next step toward building a better model of healthcare that works for everyday people," said Andrew Dudum, co-founder and CEO of Hims & Hers Health. "When healthcare innovators work together, we can make sure customer access moves at the same speed as innovation. As the largest global consumer health platform, we're thrilled to be working alongside Novo Nordisk to help more people feel their best and we're excited to find more ways to collaborate across the industry."Novo Nordisk (NYSE: NVO) is expanding patient reach through the partnership, with eligible customers now able to access treatments that can help them lose up to 20% of their body weight. Multiple Wegovy dosing options are available across both injectable and pill formats, alongside Ozempic injection pens approved for Type 2 diabetes treatment."Obesity medications have evolved over the last several years to become more affordable, more flexible, and more approachable for every kind of patient," said Dr. Craig Primack, SVP Weight Management at Hims & Hers Health. "As a part of our comprehensive treatment program, these FDA-approved medications will help more people get and stay healthy. We're excited to see how our customers succeed as more innovative treatments become available."MannKind (NASDAQ: MNKD) announced it will present new clinical data on Afrezza at the ATTD 2026 conference in Barcelona, spanning oral and poster sessions focused on real-world dosing patterns and post-prandial glucose management in both adult and pediatric patients with type 1 diabetes. The presentations include findings from the INHALE-1 study, which examined how inhaled insulin is initiated and adjusted in children and adolescents, with patients started at an approximately 2:1 conversion from rapid-acting insulin analogs."We look forward to presenting important new data for Afrezza at this year's ATTD and contributing to the scientific dialogue around meal-time diabetes management across both adult and pediatric populations," said Kevin Kaiserman, MD, Senior Vice President, Therapeutic Area Head, Diabetes for MannKind. "ATTD is a key forum for advancing how clinicians think about insulin use at meals, and we value the opportunity to engage with the global diabetes community on this important topic."The FDA accepted a supplemental Biologics License Application for Afrezza in patients ages 4-17 living with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026. If approved, Afrezza would become the first needle-free insulin option for pediatric patients in over 100 years.Ginkgo Bioworks (NYSE: DNA) launched Ginkgo Cloud Lab, a browser-based interface that gives researchers remote access to the company's autonomous lab infrastructure powered by proprietary Reconfigurable Automation Carts. The platform connects scientists to a fleet of over 70 instruments spanning sample preparation, liquid handling, analytical readouts, storage, and incubation, with an AI-driven agent called EstiMate enabling protocol submission in plain language and immediate compatibility assessment and pricing."Autonomous labs are poised to scale and accelerate the high-mix work that a lab bench supports," said Jason Kelly, CEO of Ginkgo Bioworks. "By opening up our autonomous infrastructure through the Cloud Lab, we're giving scientists access to these tools today."Ginkgo Cloud Lab is central to Ginkgo Bioworks' 2026 strategic shift to consolidate all R&D services onto Nebula, its autonomous lab in Boston, MA, decommissioning traditional benches in favor of programmable robotic infrastructure. The company is targeting users ranging from academic researchers to global biopharmaceutical companies, inviting them to submit protocols directly at cloud.ginkgo.bio for feasibility reports and price quotes.Further Reading: https://equity-insider.com/2025/11/21/the-mri-grade-disruption-hiding-in-plain-sight-why-the-smart-money-is-watching-ventripoint/CONTACT:
Equity Insider
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. (MIQ). This article is being distributed for Baystreet.ca media Corp, who has been paid a fee for an advertising campaign. MIQ has not been paid a fee for Ventripoint Diagnostics Ltd. advertising or digital media, but the owner/operators of MIQ also co-owns Baystreet.ca Media Corp. (BAY) There may also be 3rd parties who may have shares of Ventripoint Diagnostics Ltd. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY own shares of Ventripoint Diagnostics Ltd and reserve the right to buy and sell, and will buy and sell shares of Ventripoint Diagnostics Ltd. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ on behalf of BAY has been approved by Ventripoint Diagnostics Ltd.; this is a paid advertisement, we currently own shares of Ventripoint Diagnostics Ltd. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.mordorintelligence.com/industry-reports/point-of-care-diagnosticshttps://www.medtechdive.com/news/digital-health-funding-concentrates-fewer-startups-q1-2026-rock-health/816933/ https://www.globenewswire.com/news-release/2026/04/30/3285062/0/en/Global-Point-of-Care-Diagnostics-Market-Size-Set-to-Reach-USD-114-65-Billion-by-2035-SNS-Insider.html Logo: https://mma.prnewswire.com/media/2840019/Equity_Insider_Logo.jpg View original content:https://www.prnewswire.com/news-releases/the-59b-quiet-shift-reshaping-how-patients-access-care-302769492.html Original: The $59B Quiet Shift Reshaping How Patients Access Care
US Market News
5月前
Longevity Biotech Stocks Surge as $27 Trillion Healthcare Shift Favors Cell RestorationJanuary 29, 2026 1:31 PM
PR Newswire (US)
Issued on behalf of Avant Technologies Inc.VANCOUVER, BC, Jan. 29, 2026 /PRNewswire/ -- USA News Group News Commentary – Global capital is officially rotating into "Longevity Infrastructure" which is now valued at a massive $27 trillion by 2030[1]. This transition is moving the entire healthcare sector toward regenerative medicine which is projected to reach $578.59 billion by 2033[2]. We are witnessing a total structural reset that creates massive upside for bio-restorative platforms capable of a systemic re-rating. This emerging investment class includes Avant Technologies, Inc. (OTCQB: AVAI), MannKind (NASDAQ: MNKD), Altimmune (NASDAQ: ALT), Lineage Cell Therapeutics (NYSE-A: LCTX), and Arrowhead Pharmaceuticals (NASDAQ: ARWR).
The latest data shows cell therapy markets hitting $8.85 billion by 2026[3] while AI-driven drug discovery platforms are accelerating to $24.51 billion[4]. These figures confirm that institutions are now positioning for the convergence of cell-encapsulation technology and precision metabolic delivery. This structural shift is opening a massive window for platforms that can address the $65.2 billion metabolic syndrome opportunity with curative infrastructure rather than simple symptom management. For the smart money, these cell-based and gene-targeted therapies are officially the longevity alpha of the 2026 cycle.Avant Technologies, Inc. (OTCQB: AVAI) made waves at the 15th European Pancreas and Islet Transplantation Association (EPITA) Symposium, where Dr. Eva Maria Lilli Brandtner is evaluating advanced cells for potential application in a diabetes therapy. The Austria-based event, which ran January 25-27, 2026, brought together global scientists and clinicians focused on biological therapies for diabetes. EPITA stands as one of the world's flagship associations for networking on islet transplantation and beta cell replacement, making Avant's participation particularly significant for the emerging biotechnology company.Dr. Brandtner is assessing promising cells for inclusion with Avant's Cell-in-a-Box® technology, developed in partnership with SGAustria Pte. Ltd. This clinically proven microencapsulation platform solves a critical problem: when doctors transplant therapeutic cells into patients, the immune system typically destroys them within days or weeks. The traditional solution requires lifelong immunosuppressive drugs that carry serious risks, including infections, organ damage, and elevated cancer risk."While stem cell-derived beta cells undoubtedly represent a breakthrough in unlimited insulin sources, immune protection still remains a key challenge," Dr. Brandtner said. "Avant's Cell-in-a-Box® technology addresses this effectively, positioning us to contribute meaningfully to beta cell replacement therapies for type 1 and insulin-dependent type 2 diabetes patients worldwide."The cell encapsulation technology creates a protective barrier around therapeutic cells while still allowing nutrients, oxygen, and therapeutic proteins to pass through freely. This approach eliminates the need for immunosuppressive drugs while preventing potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies.Avant operates through two joint ventures targeting massive markets. Insulinova, Inc. partners with SGAustria to develop treatments for type 1 diabetes and insulin-dependent type 2 diabetes. The approach uses genetically modified cells that produce, regulate, and store insulin, essentially creating a bioartificial pancreas that restores natural glucose control. The diabetes market opportunity is substantial: 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, projected to reach 853 million by 2050 according to the International Diabetes Federation.The second venture, Klothonova, partners with Singapore-based Austrianova to develop therapies for age-related diseases and anti-aging therapies using cells that produce the Klotho protein. Research from the Mayo Clinic links declining Klotho levels to arterial stiffness, endothelial dysfunction, and vascular calcification.Both platforms are backed by over 50 peer-reviewed publications representing decades of development. The addressable markets span Alzheimer's disease ($32.8 billion by 2033), cardiovascular disease (32% of global deaths), and kidney disease (850 million affected worldwide).CONTINUED… Read this and more news for Avant Technologies Inc. at https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ and https://usanewsgroup.com/avai-profile/MannKind Corporation (NASDAQ: MNKD) announced FDA approval of an updated Prescribing Information for Afrezza (insulin human) Inhalation Powder, revising recommendations for starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens including multiple daily injections or insulin pump therapy. The updated initial conversion table is based on clinical trials in adults showing significantly improved mealtime glycemic excursions with the revised dosing approach."We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulin—whether injections or insulin pumps," said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind. "We believe this refinement to the label helps support appropriate initiation of therapy while reinforcing Afrezza's established clinical profile."The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and INHALE-3 trial demonstrating improved postprandial glucose outcomes following conversion to inhaled insulin using the now-approved conversion dose. Afrezza is the only ultra rapid-acting inhaled insulin approved by the FDA to improve glycemic control in adult patients with diabetes mellitus, administered at the beginning of meals using a small portable inhaler that delivers insulin via MannKind's proprietary Technosphere technology.Altimmune (NASDAQ: ALT) received FDA Breakthrough Therapy Designation for pemvidutide for treatment of patients with metabolic dysfunction-associated steatohepatitis. Breakthrough Therapy Designation is intended to expedite development and review of medicines treating serious conditions that have shown preliminary clinical evidence indicating potential for substantial improvement over available therapies."The FDA's Breakthrough Therapy Designation for pemvidutide in MASH reinforces the promise of its clinical profile and potential to address significant unmet needs in this serious, progressive liver disease," said Jerry Durso, President and CEO of Altimmune. "As I step into the CEO role, this designation represents an important validation for pemvidutide."Altimmune completed a productive end-of-phase 2 meeting with the FDA resulting in alignment on parameters for a registrational Phase 3 trial of pemvidutide in MASH patients with moderate to advanced liver fibrosis. The company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period incorporating biopsy-based endpoints to support a potential accelerated approval.Lineage Cell Therapeutics (NYSE-A: LCTX) has received delivery of a novel gene-edited hypoimmune cell line from Factor Bioscience under their strategic collaboration. The proprietary induced pluripotent stem cell line contains hypoimmunity edits designed to support non-immune privileged indications and includes an additional disease-specific edit with potential to differentiate this cell line from competing therapies."Our partnership with Factor supports our plan to create novel and superior product candidates by combining our manufacturing and process development capabilities with cutting-edge cell engineering and editing technologies," stated Brian M. Culley, CEO of Lineage Cell Therapeutics. "This achievement under our collaboration with Factor supports our plan to broaden our cell therapy platform through the addition of new technologies and indications, as we await further updates from our lead cell therapy program, OpRegen, for dry age-related macular degeneration with geographic atrophy."Lineage will evaluate the cell line for its ability to adapt to the company's proprietary AlloSCOPE manufacturing platform. The clinical-stage biotechnology company develops allogeneic cell therapies for serious medical conditions with a pipeline including OpRegen for retinal disease and OPC1 for spinal cord injuries.Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-DIMER-PA, the first clinical candidate designed to silence expression of two genes simultaneously in one molecule for treatment of atherosclerotic cardiovascular disease due to mixed hyperlipidemia. The investigational RNA interference therapeutic targets both proprotein convertase subtilisin kexin 9 and apolipoprotein C3 genes, representing an important step forward enabled by Arrowhead's proprietary Targeted RNAi Molecule platform."Arrowhead is at the forefront of innovation in the RNAi field, and we're proud of the versatile capabilities of our TRiM platform, now including the first-ever clinical candidate that can potentially silence expression of two genes in one RNAi molecule," said Chris Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. "ARO-DIMER-PA is designed to silence both the PCSK9 and APOC3 genes, which together have substantial clinical validation as important targets for reducing LDL-cholesterol, triglycerides, and total atherogenic lipoproteins."In preclinical studies, ARO-DIMER-PA potently lowered serum PCSK9 and APOC3 and ameliorated high levels of non-HDL-cholesterol, LDL-cholesterol, and triglycerides in hyperlipidemic nonhuman primates. The initiation advances Arrowhead's growing cardiometabolic portfolio including commercial product REDEMPLO approved in the United States, Canada, and China for familial chylomicronemia syndrome, ongoing Phase 3 study of zodasiran in homozygous familial hypercholesterolemia, and Phase 1/2 studies of ARO-INHBE and ARO-ALK7 for obesity.Source: https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES CITED:https://theweek.com/business/longevity-economy-booming-live-longerhttps://www.globenewswire.com/news-release/2026/01/27/3226653/0/en/Regenerative-Medicine-Market-Review-2020-2024-and-Forecast-2025-2033-A-578-29-Bn-Opportunity-Says-Astute-Analytica.htmlhttps://www.towardshealthcare.com/insights/cell-therapy-market-sizinghttps://www.towardshealthcare.com/insights/artificial-intelligence-in-drug-discovery Logo - https://mma.prnewswire.com/media/2838876/5742703/USA_News_Group_Logo.jpg
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Original: Longevity Biotech Stocks Surge as $27 Trillion Healthcare Shift Favors Cell Restoration
US Market News
5月前
Breaking Barriers: How 2026's Top Clinical Leaders Are Disrupting Chronic Disease MarketsJanuary 26, 2026 3:16 PM
PR Newswire (US)
Issued on behalf of Avant Technologies Inc.Equity Insider News CommentaryVANCOUVER, BC, Jan. 26, 2026 /PRNewswire/ -- The medical world is shifting as the global market for next-gen treatments heads toward $88.85 billion by 2030[1], driven by a surge in funding for high-tech cures for long-term illness. A major FDA move at the beginning of the year[2] is now making it much easier to build these advanced platforms, clearing a path for companies that can treat diseases internally without the harsh side effects of traditional drugs. This regulatory shift positions Avant Technologies, Inc. (OTCQB: AVAI), MannKind (NASAQ: MNKD), Vertex Pharmaceuticals (NASDAQ: VRTX), Fate Therapeutics (NASDAQ: FATE), and Ardelyx (NADSAQ: ARDX) at the center of a massive transformation in chronic healthcare. Smart investors are preparing for a major 2026 rebound as capital flows into the most innovative and results-driven medical platforms[3]. With the total biotech sector projected to reach $9.06 trillion by 2035[4], the biggest opportunities are in companies solving massive issues like diabetes and kidney disease with better clinical execution. In 2026, the market is favoring 'ready-to-go' platforms over early-stage speculation, rewarding the companies that have built the infrastructure to dominate the next generation of medicine.Avant Technologies, Inc. (OTCQB: AVAI) is tackling some of healthcare's biggest challenges with a novel approach: genetically modified cells that produce therapeutic proteins inside the body, protected by a proprietary shield that keeps the immune system from attacking them. The company operates through two joint ventures targeting markets worth hundreds of billions of dollars.The core innovation is a cell encapsulation technology that solves a fundamental problem in regenerative medicine. When doctors transplant therapeutic cells into patients, the immune system typically destroys them within days or weeks. The traditional solution requires lifelong immunosuppressive drugs that cause serious side effects including infection risk, organ damage, and elevated cancer risk. Avant's technology eliminates this problem by creating a protective barrier around the cells while still allowing nutrients, oxygen, and therapeutic proteins to pass through freely.The first venture, Insulinova, Inc., partners with SGAustria Pte. Ltd. to develop treatments for type 1 diabetes and insulin-dependent type 2 diabetes. The approach uses genetically modified cells that produce, regulate and store insulin, essentially creating a bio artificial pancreas that restores natural glucose control without immunosuppressive drugs. The diabetes market opportunity is substantial: 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, projected to reach 853 million by 2050 according to the International Diabetes Federation."Cell encapsulation is a game changer in the field of regenerative medicine," said Chris Winter, CEO of Avant Technologies. "By partnering with SGAustria, we're ensuring that genetically modified insulin-producing cells can thrive in the body long-term and offer the potential of restoring natural glucose control and dramatically improving patients' quality of life. This technology not only minimizes risks like immune rejection but also prevents potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies."Avant's second venture, Klothonova, partners with Singapore-based Austrianova to develop therapies for both age-related diseases and anti-aging therapies using cells that produce the Klotho protein. Research from the Mayo Clinic links declining Klotho levels to arterial stiffness, endothelial dysfunction, and vascular calcification.Both platforms are backed by over 50 peer-reviewed publications representing decades of development. The addressable markets span multiple areas: Alzheimer's disease ($32.8 billion by 2033), cardiovascular disease (32% of global deaths), and kidney disease (850 million affected worldwide).The strategic advantage lies in platform versatility. The same encapsulation technology that protects insulin-producing cells can theoretically protect cells producing other therapeutic proteins, potentially opening pathways into additional disease indications. This positions Avant at the intersection of multiple high-value healthcare markets with a single core technology that addresses the immune rejection challenge across different applications.CONTINUED... Read this and more news for Avant Technologies at:
https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ MannKind (NASDAQ: MNKD) provided business updates outlining anticipated growth drivers for 2026, including progress across commercial programs and clinical development initiatives following a record-setting fourth quarter surpassing $100 million in net revenue. The company expects two high-potential launches on the horizon with FDA decisions anticipated for Afrezza label updates and FUROSCIX ReadyFlow Autoinjector."MannKind closed 2025 on a high note, marked by milestones that reinforce our growth trajectory—including the acquisition of scPharmaceuticals and a record-setting fourth quarter surpassing $100 million in net revenue," said Michael Castagna, PharmD, CEO of MannKind Corporation. "With two high-potential launches on the horizon, 2026 is shaping up to be a catalyst-rich year that positions MannKind for long-term value creation."Major catalysts include an FDA decision on Afrezza dose conversion with PDUFA date of January 23, 2026, and review of the supplemental BLA for Afrezza in pediatric patients with PDUFA date of May 29, 2026. MannKind also continues advancing its pipeline including nintedanib DPI with first patient enrollment in the INFLO-1 Phase 1b study completed in December.Vertex Pharmaceuticals (NASDAQ: VRTX) provided pipeline and business updates ahead of the J.P. Morgan Healthcare Conference, highlighting strong commercial execution and rapid R&D progress setting up continued growth and important milestones for 2026. The company increased estimates for people with CF in all target markets to approximately 112,000 including approximately 97,000 in core markets, while CASGEVY realized greater than $100 million revenue in 2025 reflecting more than 60 patient infusions."2025 was a year of strong commercial execution and rapid R&D progress, setting up the company for continued growth and many important milestones in 2026," said Reshma Kewalramani, M.D., CEO and President of Vertex. "Building on this momentum, we are focused on expanding our commercial reach in multiple disease areas; advancing the emerging renal franchise, including the potential near-term launch of povetacicept; and progressing our mid- and late-stage clinical pipeline."Vertex expects to complete the rolling BLA filing for U.S. accelerated approval of povetacicept in IgAN in the first half of 2026 using a priority review voucher to expedite review from ten months to six months. The company also plans to complete enrollment in both Phase 3 studies of suzetrigine in diabetic peripheral neuropathy by end of 2026, with more than 500,000 JOURNAVX prescriptions written and filled in 2025.Fate Therapeutics (NASDAQ: FATE) presented updated Phase 1 clinical data of FT819 off-the-shelf CAR T-cell product candidate demonstrating meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus patients now treated and first systemic sclerosis patient dosed. The company continues to advance preparations for a pivotal study and is engaged in discussions with the FDA under its RMAT designation regarding plans to initiate registrational trial in 2026."We are very pleased with the accelerating patient enrollment, the expansion of U.S. clinical sites, and the addition of international clinical sites, which together are enabling broader access to FT819 for patients suffering with lupus," said Bob Valamehr, Ph.D., M.B.A., President and CEO of Fate Therapeutics. "The updated FT819 clinical data continue to demonstrate meaningful and durable responses with the use of less-intensive conditioning chemotherapy and a differentiated safety profile."Preliminary data in Regimen A showed mean SLEDAI-2K score decreased progressively from baseline with DL1 dropping 50% at month 3 and 70% at month 6, while DL2 decreased 65% at month 3 and 78% at month 6. Clinical SLEDAI-2K of 0 was achieved in 5 out of 10 patients with no Grade >2 CRS, ICANS, or GVHD reported.Ardelyx (NASDAQ: ARDX) presented real-world evidence studies of XPHOZAH (tenapanor) demonstrating patient satisfaction and reduction in serum phosphate at the American Society of Nephrology's Kidney Week. The first real-world study showed patients prescribed tenapanor experienced a reduction in serum phosphate of nearly 1 mg/dL on average, with 45.3% experiencing at least 1 mg/dL reduction."We are excited to present new data on XPHOZAH at ASN's Kidney Week, including the first results from our prospective, observational cohort study designed to evaluate the impact of an XPHOZAH-based regimen in a real-world setting," said Edward Conner, Chief Medical Officer. "Our results show the impact XPHOZAH can have in reducing serum phosphorus levels for these patients."Real-world survey data collected through the ArdelyxAssist patient services program showed that 63% of patients reported their phosphate levels were better since starting tenapanor. Among patients who reported a change in serum phosphate levels, 69% indicated their outlook on serum phosphate control was better, with improvements attributed to better control, improved bowel movements, and lower pill burden.Source: https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors- need-to-know/ CONTACT:
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Original: Breaking Barriers: How 2026's Top Clinical Leaders Are Disrupting Chronic Disease Markets
chrismiss_everyday
1年前
https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-showcases-efficacy-safety-and-mealtime-control-data
*Five presentations affirm positive outcomes utilizing inhaled insulin
*An sNDA filing for Afrezza in pediatric population anticipated in 2025
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.
“Data from both the INHALE-1 pediatric and INHALE-3 adult studies continue to drive groundbreaking conversations around inhaled insulin,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. "Afrezza continues to be an important treatment option for adults living with diabetes, including those utilizing MDI and AID, and we look forward to the study investigators’ presentations at the ATTD meeting.”
The following oral presentations are on the scientific program at ATTD 2025 to be held virtually and at the RAI Amsterdam Convention Center:
What’s New in Pulmonary Inhaled Insulin?
Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I
Presenter: Dr. Irl B. Hirsch
Inhaled Insulin in Pediatrics (INHALE-1 Peds Study)
Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I
Presenter: Dr. Michael J. Haller
Sustained Benefit from Use of Inhaled Insulin in the INHALE-3 Extension Study
Saturday, March 22, 2025 – 11:05 AM (CET) at Station 4
Presenter: Dr. Grazia Aleppo
Post-Prandial Glucose Excursion with Inhaled Insulin in Youth Compared with Adults with Type 1 Diabetes (INHALE-1 Peds Study)
Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2
Presenter: Dr. Michael J. Haller
Comparison of a Regimen of Inhaled Technosphere Insulin Plus Insulin Degludec Versus Usual Care in Adults with Type 1 Diabetes
Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2
Presenter: Dr. Anastasios Manessis
In addition to the planned presentations, MannKind will host booth #40 in the exhibit hall (Hall I) throughout ATTD. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.
For more information about ATTD programming, and/or to register to attend the conference (virtual or in person), please visit: https://attd.kenes.com/register/.
About the INHALE-1 Pediatric Study
INHALE-1 is a Phase 3, randomized controlled trial in children and teenagers aged 4-17 with type 1 or type 2 diabetes to evaluate the efficacy and safety of inhaled insulin in combination with basal insulin versus multiple daily injections of rapid acting insulin in combination with basal insulin. The 26-week, open-label clinical trial randomized 230 pediatric subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing. Six-month results were announced by MannKind in December 2024, and 12-month findings are expected mid-year 2025.
About the INHALE-3 Study (Adults)
The INHALE-3 study was a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control.
The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The 17-week results shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks. The 30-week results from the study expanded upon the positive 17-week data and showed that more people living with T1D were able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care.
About Afrezza
Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.