Latest news with #Equillium
Yahoo
2 days ago
- Business
- Yahoo
4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape
Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities. LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD). As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034. Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy. Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development. To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market. Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics. Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment CSL Behring's ZEMAIRA CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD. Equillium/Biocon's EQ001 EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance. Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data. Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market MaaT Pharma's MaaT013 MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA. In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD. medac's MC0518 MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment. The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models. Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight's latest published market report, titled as Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total allogenic transplant cases Total Graft Versus Host Disease Cases Type-specific Cases of Graft Versus Host Disease Acute Graft Versus Host Disease Cases by Grading Acute Graft Versus Host Disease Cases by Organ Involvement Chronic Graft Versus Host Disease Cases by Grading Chronic Graft Versus Host Disease Cases by Organ Involvement Total Treated Cases of Graft Versus Host Disease Mortality Adjusted Treated Cases of Graft Versus Host Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space. Related Reports Graft versus Host Disease Epidemiology Forecast Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan. Graft versus Host Disease Pipeline Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen, among others. Acute Graft versus Host Disease Pipeline Acute Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation, among others. Ocular Graft versus Host Disease Pipeline Ocular Graft versus Host Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP
Globe and Mail
13-03-2025
- Business
- Globe and Mail
Graft Versus Host Disease Market is Projected for Substantial Expansion from USD 1.3 Billion in 2023
The key Graft Versus Host Disease companies including CSL Behring, Equillium, Biocon, MaaT Pharma, REGiMMUNE, ReAlta Life Sciences, Ono Pharmaceutical (Deciphera Pharmaceuticals), Medsenic, BioSenic, ASC Therapeutics, Cynata Therapeutics, Evive Biotech (Yifan Pharmaceutical), Ironwood, Medac, and others The 7MM Graft Versus Host Disease (GvHD) market has demonstrated substantial growth in recent years, fueled by rising transplant rates, an aging population, and the introduction of innovative therapies such as ZEMAIRA, EQ001, MaaT013, and RGI-2001, among others. According to DelveInsight's comprehensive analysis, key pharmaceutical companies including ICSL Behring, Equillium, Biocon, MaaT Pharma, REGiMMUNE, ReAlta Life Sciences, Ono Pharmaceutical (Deciphera Pharmaceuticals), Medsenic, BioSenic, ASC Therapeutics, Cynata Therapeutics, Evive Biotech (Yifan Pharmaceutical), Ironwood, Medac, and others leading innovation in this space. DelveInsight's ' Graft Versus Host Disease Market Insights, Epidemiology, and Market Forecast – 2034 ' report provides an in-depth understanding of Graft Versus Host Disease (GvHD), historical and forecasted epidemiology, as well as the Graft Versus Host Disease market trends in the 7MM which include the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. The GvHD market forecast anticipates a CAGR of 8.2% through 2034 over the study period (2020-2034) from USD 1.3 Billion in 2023. Regionally, the United States represents around 70% of the GvHD market, thanks to favorable reimbursement policies and rapid adoption of new, premium-priced therapies. The EU4 and the UK together account for about 19% of the GvHD market. Download the GvHD market report to understand which factors are driving the Graft Versus Host Disease therapeutic market @ Graft Versus Host Disease Market Trends The report also analyzes historical and projected epidemiology segmented by total allogenic transplant cases, total Graft Versus Host Disease prevalence, type-specific cases of Graft Versus Host Disease, Graft Versus Host Disease cases by grading, Graft Versus Host Disease cases by organ involvement, Graft Versus Host Disease cases by grading, Graft Versus Host Disease cases by organ involvement, total treated cases of Graft Versus Host Disease, and mortality adjusted treated cases of Graft Versus Host Disease. DelveInsight estimates approximately 52K cases of Graft Versus Host Disease in the 7MM. In 2023, the EU4 and the UK recorded the highest incidence of Grade D[IV] Graft-Versus-Host Disease, aligning with patterns observed in hematologic malignancy transplants. Discover evolving trends in Graft Versus Host Disease patient pool forecasts @ Graft Versus Host Disease Epidemiology Analysis. The Graft Versus Host Disease Treatment Market Report provides insights into current GvHD treatment practices, emerging drugs, market share of individual therapies, and forecasts for the 7MM GvHD market size from 2020 to 2034. Current Graft Versus Host Disease therapies include steroids, NIKTIMVO, JAKAFI, IMBRUVICA, RYONCIL/TEMCELL HS, and ORENCIA, among others. Graft Versus Host Disease Treatment is evolving from broad immunosuppression to targeted and cell-based therapies. JAKAFI (ruxolitinib), a JAK1/JAK2 inhibitor, is a cornerstone of GvHD treatment and generates substantial revenue due to its proven efficacy in steroid-refractory cases. DelveInsight's analysis indicates that the GvHD clinical trials market is highly active, with numerous investigational therapies in various stages of development. Notable candidates include ZEMAIRA (CSL Behring), EQ001 (Equillium/Biocon), MaaT013 (MaaT Pharma), RGI-2001 (REGiMMUNE), MC0518 (Medac), RLS-0071 (ReAlta Life Sciences), VIMSELTINIB (Deciphera Pharmaceuticals), ARSCIMED (Medsenic/BioSenic), ASC-930 (ASC Therapeutics), CYP-001 (Cynata Therapeutics), F-652 (Yifan Pharmaceutical), and APRAGLUTIDE (Ironwood), among others. Unlock which Graft Versus Host emerging Disease drug is expected to capture the largest market share in 7MM by 2034. Visit the Graft Versus Host Disease Market Insights. In January 2025, the FDA approved Incyte's and Syndax's Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes for the treatment of chronic graft-versus-host disease (GVHD) in adults and pediatric patients based on data from the AGAVE-201 trial. This demonstrates encouraging progress in the graft versus host disease clinical trials market. Upcoming milestones may include potential label expansions of cellular therapies like mesenchymal stromal cells, which could redefine first-line treatment strategies. However, challenges remain, such as standardizing response criteria across clinical trials and addressing the financial strain associated with chronic graft versus host disease treatment. DelveInsight's report emphasizes that overcoming these challenges will require collaboration among pharmaceutical stakeholders and transplant networks to optimize patient stratification and track outcomes effectively. Table of Contents 1. Key Insights 2. Report Introduction 3. GvHD Market Overview at a Glance 4. Executive Summary 5. Key Events 6. Disease Background and Overview 7. Methodology 8. Epidemiology and Patient Population 9. Patient Journey 10. Marketed Drugs 11. Emerging Drugs 12. GvHD – 7MM Market Analysis 13. KOL Views 14. Unmet Needs 15. SWOT Analysis 16. Market Access and Reimbursement 16.1. The US 17. Appendix 18. DelveInsight Capabilities 19. Disclaimer 20. About DelveInsight Related Reports Graft versus host disease (GvHD) Pipeline Insight Graft versus host disease Pipeline Insight provides comprehensive insights about the GvHD pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical Co., Ltd, CTI BioPharma, ViGenCell Inc., Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK and Amgen among others. About DelveInsight DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Arpit Anand Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Yahoo
07-02-2025
- Business
- Yahoo
CuriosityStream And 2 Other Promising Penny Stocks On US Exchange
As the S&P 500 inches toward a record high and investors digest a flurry of earnings reports, the spotlight on smaller market players has intensified. Penny stocks, while often considered relics of past market eras, continue to offer intriguing opportunities for those willing to explore beyond the major indices. Typically associated with smaller or newer companies, these stocks can present an appealing mix of affordability and growth potential when backed by strong financials. Name Share Price Market Cap Financial Health Rating BAB (OTCPK:BABB) $0.88 $6.38M ★★★★★★ QuantaSing Group (NasdaqGM:QSG) $3.08 $120.63M ★★★★★★ ZTEST Electronics (OTCPK:ZTST.F) $0.2798 $10.12M ★★★★★★ Imperial Petroleum (NasdaqCM:IMPP) $2.99 $90.69M ★★★★★★ Golden Growers Cooperative (OTCPK:GGRO.U) $4.50 $67.38M ★★★★★★ BTCS (NasdaqCM:BTCS) $2.95 $53.09M ★★★★★★ North European Oil Royalty Trust (NYSE:NRT) $4.82 $45.59M ★★★★★★ Permianville Royalty Trust (NYSE:PVL) $1.415 $46.86M ★★★★★★ Smith Micro Software (NasdaqCM:SMSI) $1.52 $26.96M ★★★★★☆ CBAK Energy Technology (NasdaqCM:CBAT) $0.882 $81.84M ★★★★★☆ Click here to see the full list of 706 stocks from our US Penny Stocks screener. Here we highlight a subset of our preferred stocks from the screener. Simply Wall St Financial Health Rating: ★★★★★★ Overview: CuriosityStream Inc. operates as a factual content streaming service and media company with a market cap of $156.17 million. Operations: The company's revenue segment is derived entirely from its factual content streaming service, amounting to $51.78 million. Market Cap: $156.17M CuriosityStream, with a market cap of US$156.17 million, has been reducing its losses at an annual rate of 11.6% over the past five years despite being unprofitable. The company maintains a strong financial position with short-term assets of US$39.1 million exceeding both its short-term and long-term liabilities, and it remains debt-free. CuriosityStream's cash runway is sufficient for more than three years if current free cash flow levels are maintained or grow as expected. Recently, the company increased its quarterly dividend by 20%, indicating confidence in its financial stability despite ongoing volatility concerns. Unlock comprehensive insights into our analysis of CuriosityStream stock in this financial health report. Gain insights into CuriosityStream's future direction by reviewing our growth report. Simply Wall St Financial Health Rating: ★★★★★☆ Overview: Equillium, Inc. is a clinical-stage biotechnology company focused on developing and selling products for severe autoimmune and immuno-inflammatory disorders with unmet medical needs, with a market cap of $25.15 million. Operations: Equillium's revenue is derived entirely from its Pharmaceuticals segment, totaling $45.91 million. Market Cap: $25.15M Equillium, Inc., with a market cap of US$25.15 million, is a clinical-stage biotech firm focusing on severe autoimmune disorders. Despite being unprofitable, it has reduced losses by 9% annually over the past five years and remains debt-free. The company recently reported positive Phase 2 study results for itolizumab in ulcerative colitis treatment, showing promise in clinical remission rates compared to standard treatments. However, Equillium faces challenges with Nasdaq compliance due to its stock trading below US$1.00 per share and may consider actions like a reverse stock split to regain compliance by June 2025. Dive into the specifics of Equillium here with our thorough balance sheet health report. Examine Equillium's earnings growth report to understand how analysts expect it to perform. Simply Wall St Financial Health Rating: ★★★★★☆ Overview: KORU Medical Systems, Inc. develops and manufactures medical devices and supplies both in the United States and internationally, with a market cap of $224.60 million. Operations: The company generates revenue of $31.99 million from its Surgical & Medical Equipment segment. Market Cap: $224.6M KORU Medical Systems, with a market cap of US$224.60 million, is experiencing revenue growth, expecting full-year 2024 revenues of US$33.7 million, up 18% from the previous year. Despite being unprofitable and having increased losses over the past five years at a rate of 50.6% per year, it maintains strong financial health with short-term assets exceeding liabilities and more cash than total debt. Recent collaboration on a Phase III trial for treating rare renal disorders highlights its strategic partnerships in expanding drug delivery solutions. The management team is experienced with an average tenure of 3.1 years. Click to explore a detailed breakdown of our findings in KORU Medical Systems' financial health report. Learn about KORU Medical Systems' future growth trajectory here. Investigate our full lineup of 706 US Penny Stocks right here. Hold shares in these firms? Setup your portfolio in Simply Wall St to seamlessly track your investments and receive personalized updates on your portfolio's performance. Take control of your financial future using Simply Wall St, offering free, in-depth knowledge of international markets to every investor. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Jump on the AI train with fast growing tech companies forging a new era of innovation. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqCM:CURI NasdaqCM:EQ and NasdaqCM:KRMD. Have feedback on this article? 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