Latest news with #MesoblastLimited
Yahoo
2 days ago
- Business
- Yahoo
Mesoblast Limited (MESO) Launches First Cell Therapy for Children
We recently compiled a list of Mesoblast Limited stands tenth on our list and has launched the first cell therapy for children. Mesoblast Limited (NASDAQ:MESO) is among the best mid-cap stocks to buy according to billionaires. It is a global leader in developing allogeneic (off-the-shelf) cellular medicines using its proprietary mesenchymal lineage cell technology. The company targets severe inflammatory diseases that lack effective treatment options. Its lead product, Ryoncil (remestemcel-L), became the first and only FDA-approved mesenchymal stromal cell therapy for children with steroid-refractory acute graft versus host disease (GVHD) in March 2025. Following approval, Mesoblast Limited (NASDAQ:MESO) rapidly launched the drug, partnering with over 25 major U.S. transplant centers and securing insurance coverage for over 250 million lives, including mandatory Medicaid coverage in all states. Ryoncil now benefits from seven years of orphan drug exclusivity and biologic exclusivity until 2036, with intellectual property protection through 2044, effectively limiting competition. The approval marks the foundation of the business's broader pediatric inflammatory disease franchise, with plans to expand Ryoncil's use to additional pediatric and adult indications. A healthcare professional examining T-cell immunotherapy. The corporation's manufacturing processes allow scalable production of consistent cell therapies without the need for donor-recipient matching, simplifying access and logistics. The company is also advancing other key candidates: Revascor (rexlemestrocel-L) for ischemic heart failure, which is on track for FDA submission by the end of 2025 under RMAT designation, and a Phase 3 program for rexlemestrocel-L targeting chronic discogenic low back pain, offering a non-opioid alternative for patients. While we acknowledge the potential of MESO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Sign in to access your portfolio
Yahoo
16-06-2025
- Health
- Yahoo
Chronic Lower Back Pain Market to Expand Significantly During the Forecast Period (2025-2034) with Game-Changing Therapies
The overall chronic lower back pain market is expected to boost with the expected launch of emerging therapies such as SP-102 (Scilex Holding), Rexlemestrocel-L (Mesoblast Limited), Cebranopadol (TRN-228) (Tris Pharma), and others, increased awareness, and extensive research in the forecast period (2025–2034). LAS VEGAS, June 16, 2025 /PRNewswire/ -- Chronic low back pain (CLBP) is a widespread and long-lasting condition defined by lower back pain that lasts for at least 12 weeks. The lower back's complex structure, involving bones, muscles, ligaments, and nerves, makes it vulnerable to various problems. CLBP symptoms vary, but typically include persistent pain beyond 12 weeks, stiffness, limited movement, muscle spasms, and sometimes pain radiating to the buttocks, thighs, or legs. In 2023, there were approximately 80 million prevalent cases of CLBP across the 7MM, and this number is projected to increase between 2020 and 2034. DelveInsight estimates that in 2023, diagnosed prevalent cases of CLBP in the US accounted for about 45% of the total in the 7MM, with a concerning trend indicating a future rise in diagnosed cases. Chronic low back pain treatment approaches are customized to each patient, utilizing different medication types that target specific pain mechanisms. Individual patient characteristics are key to creating personalized treatment plans that improve adherence and results. However, when inflammation is the cause of low back pain, treatment includes anti-inflammatory medications such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or disease-modifying antirheumatic drugs (DMARDs) for patients with conditions like rheumatoid arthritis or ankylosing spondylitis. Learn more about the CLBP market @ New Treatment for Chronic Lower Back Pain Patients with certain conditions that contribute to CLBP are more likely to experience neuropathic pain, which may require additional medications that specifically target this type of pain. Furthermore, some individuals with mechanical low back pain may also experience increased pain due to muscle spasms, which can be alleviated with antispasmodic treatments. The primary approach to managing CLBP involves the use of non-opioid pain relievers, such as NSAIDs, to address pain caused or exacerbated by inflammation. If neuropathic pain is present, medications that target this specific type of pain should be initiated and optimized accordingly. Acetaminophen (paracetamol) is the preferred initial treatment for both acute and chronic pain. However, due to safety concerns, the FDA has limited the amount of acetaminophen in combination products to 325mg. For patients with CLBP who require ongoing, around-the-clock pain management, the FDA has approved medications like XTAMPZA, BUTRANS, and BELBUCA. These opioids are intended for use when alternative treatments are ineffective. Additionally, CYMBALTA has been approved for managing related conditions, including chronic musculoskeletal pain and osteoarthritis-related chronic pain, which often co-occur with CLBP. Collegium Pharmaceutical's XTAMPZA ER (oxycodone), a semi-synthetic opioid, is approved for both immediate-release and extended-release formulations. The FDA tentatively approved XTAMPZA in November 2015 and later approved an enhanced label in May 2016. The extended-release version, a twice-daily capsule, gained FDA approval in April 2016 for severe pain requiring long-term opioid management when other options are insufficient, and was commercially launched in the US in June 2016. Patents for XTAMPZA and its DETrx technology are set to expire in 2025, with potential extensions to 2036 pending patent approvals. BELBUCA, a buccal film containing the Schedule III opioid buprenorphine, was developed by BioDelivery Sciences International (BDSI) and approved by the FDA in October 2015 for similar long-term, around-the-clock pain management where alternatives are inadequate. Patents related to BELBUCA's BEMA drug delivery technology extend its exclusivity in the US to 2027 and potentially to December 2032. In February 2022, Collegium Pharmaceutical announced its acquisition of BDSI for $5.60 per share. Find out more on FDA-approved CLBP drugs @ Chronic Lower Back Pain Treatment Market The chronic lower back pain treatment drug market is continuously evolving. Several pharma companies are evaluating their lead assets in different phases of development. Many potential therapies are being investigated to manage chronic lower back pain. Some of the drugs in the pipeline include SP-102 (Scilex Holding), Rexlemestrocel-L (Mesoblast Limited), Cebranopadol (TRN-228) (Tris Pharma), and others. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2025–2034), it is safe to assume that the future of this market is bright. Discover which therapies are expected to grab major CLBP treatment drug market @ Chronic Lower Back Pain Market Report Scilex Holding's SEMDEXA (SP-102), a non-opioid corticosteroid viscous gel injection, is being developed for lumbar radicular pain/sciatica. It lacks neurotoxic additives and has successfully completed Phase III trials, meeting its primary and secondary goals. Results from this pivotal trial were published in the journal PAIN in June 2024. In May 2025, Scilex Holding Company presented a post-hoc analysis of the C.L.E.A.R. trial at the ASIPP 2025 meeting. The analysis focused on the clinical meaningfulness of SP-102 (SEMDEXA) for treating lumbosacral radicular pain. Mesoblast Limited is developing Rexlemestrocel-L (MPC-06-ID), an allogeneic mesenchymal precursor cell product, for chronic low back pain caused by disc degeneration. This treatment is intended for patients who have not responded to conservative treatments or epidural steroid injections and are seeking an alternative to surgery; it has completed Phase III development. Cebranopadol (TRN-228), a dual nociception/orphanin FQ peptide (NOP) and μ-opioid peptide (MOP) receptor agonist, is a novel drug in development for moderate to severe pain. By targeting both NOP and MOP receptors, it aims to provide opioid-like pain relief with improved safety and a reduced risk of dependence and abuse. The FDA granted Fast Track Designation to cebranopadol for CLBP in 2017, and it is currently in Phase III trials for acute pain. In September 2024, Tris Pharma announced clinical data showing cebranopadol offers strong, lasting pain relief with 25% less respiratory depression compared to oxycodone; these findings were presented at PAIN Week. Discover more about drugs for CLBP in development @ Chronic Lower Back Pain Clinical Trials The anticipated launch of these emerging therapies for chronic lower back pain 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 chronic lower back pain market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the US market size for chronic lower back pain is expected to grow from USD 4.2 billion in 2023 at a significant CAGR by 2034. The chronic lower back pain treatment market is driven by an aging population, rising prevalence due to sedentary lifestyles and stress, and advancements in treatments and diagnostics. Increased demand is driven by age-related spinal changes and the need for improved therapies and early interventions. DelveInsight's latest published market report, titled as Chronic Lower Back Pain 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 chronic lower back pain country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The chronic lower back pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of CLBP Total Diagnosed Prevalent Cases of CLBP Gender-specific Diagnosed Prevalent Cases of CLBP Age-specific Diagnosed Prevalent Cases of CLBP The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM chronic lower back pain 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 chronic lower back pain 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 chronic lower back pain market. Also, stay abreast of the mitigating factors to improve your market position in the chronic lower back pain therapeutic space. Related Reports Chronic Lower Back Pain Epidemiology Chronic Lower Back Pain Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the CLBP epidemiology trends. Chronic Lower Back Pain Pipeline Chronic Lower Back Pain Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CLBP companies, including Mesoblast, Eli Lilly and Company, Persica Pharmaceuticals, CHABiotech, Allodynic Therapeutics, Stayble Therapeutics, Xgene Pharmaceutical, Imbrium Therapeutics, Camurus, among others. Peripheral Neuropathic Pain Market Peripheral Neuropathic Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PNP companies, including Daiichi Sankyo, Scilex Pharmaceuticals, Azurity Pharmaceuticals, Lexicon Pharmaceuticals, Merz Therapeutics, Apurano Pharmaceuticals, Vertex Pharmaceuticals, WEX Pharmaceuticals, Scilex Holding Company, among others. Postoperative Pain Market Postoperative Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postoperative pain companies, including Taiwan Liposome Company (TLC), Teikoku Pharma USA, Novartis Pharmaceuticals, Concentric Analgesics, Mati Therapeutics, Arthritis Innovation Corporation, MedinCell, Surface Ophthalmics, Salvat Laboratories, Grünenthal, Vertex Pharmaceuticals, Formosa Pharmaceuticals, Oculis, Neumentum Pharmaceuticals, Charleston Laboratories, 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
Yahoo
07-05-2025
- Business
- Yahoo
Mesoblast Limited's (ASX:MSB) market cap dropped AU$96m last week; Individual investors bore the brunt
Key Insights Significant control over Mesoblast by individual investors implies that the general public has more power to influence management and governance-related decisions 50% of the business is held by the top 8 shareholders Recent purchases by insiders This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. To get a sense of who is truly in control of Mesoblast Limited (ASX:MSB), it is important to understand the ownership structure of the business. The group holding the most number of shares in the company, around 39% to be precise, is individual investors. That is, the group stands to benefit the most if the stock rises (or lose the most if there is a downturn). While insiders who own 37% came under pressure after market cap dropped to AU$2.2b last week,individual investors took the most losses. Let's delve deeper into each type of owner of Mesoblast, beginning with the chart below. View our latest analysis for Mesoblast ASX:MSB Ownership Breakdown May 7th 2025 What Does The Institutional Ownership Tell Us About Mesoblast? Many institutions measure their performance against an index that approximates the local market. So they usually pay more attention to companies that are included in major indices. Mesoblast already has institutions on the share registry. Indeed, they own a respectable stake in the company. This can indicate that the company has a certain degree of credibility in the investment community. However, it is best to be wary of relying on the supposed validation that comes with institutional investors. They too, get it wrong sometimes. It is not uncommon to see a big share price drop if two large institutional investors try to sell out of a stock at the same time. So it is worth checking the past earnings trajectory of Mesoblast, (below). Of course, keep in mind that there are other factors to consider, too. ASX:MSB Earnings and Revenue Growth May 7th 2025 Hedge funds don't have many shares in Mesoblast. Looking at our data, we can see that the largest shareholder is Gregory George with 20% of shares outstanding. Silviu Itescu is the second largest shareholder owning 6.2% of common stock, and Grant George holds about 5.2% of the company stock. Silviu Itescu, who is the second-largest shareholder, also happens to hold the title of Chief Executive Officer. We also observed that the top 8 shareholders account for more than half of the share register, with a few smaller shareholders to balance the interests of the larger ones to a certain extent. Researching institutional ownership is a good way to gauge and filter a stock's expected performance. The same can be achieved by studying analyst sentiments. There are a reasonable number of analysts covering the stock, so it might be useful to find out their aggregate view on the future.
Business Insider
01-05-2025
- Business
- Business Insider
Mesoblast Limited (MEOBF) Receives a Buy from Bell Potter
Bell Potter analyst John Hester maintained a Buy rating on Mesoblast Limited (MEOBF – Research Report) today and set a price target of A$3.40. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Hester covers the Healthcare sector, focusing on stocks such as Polynovo , Mesoblast Limited, and Telix Pharmaceuticals. According to TipRanks, Hester has an average return of 4.8% and a 50.60% success rate on recommended stocks. The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Mesoblast Limited with a $1.86 average price target. Based on Mesoblast Limited's latest earnings release for the quarter ending December 31, the company reported a quarterly revenue of $1.58 million and a GAAP net loss of $23.97 million. In comparison, last year the company earned a revenue of $1.69 million and had a GAAP net loss of $16.27 million Based on the recent corporate insider activity of 10 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of MEOBF in relation to earlier this year.
Yahoo
03-03-2025
- Health
- Yahoo
Ryoncil, the first FDA-approved mesenchymal stromal cell therapy
Regenerative medicine, a rapidly advancing field, can be generally defined as a therapeutic methodology for the repair, regeneration, or replacement of damaged or diseased human cells and tissues. Ryoncil is an allogeneic mesenchymal stromal cell (MSC) therapy indicated for the treatment of acute graft-versus-host disease (aGvHD) for children older than two months, including adolescents and teenagers. aGvHD is a common complication of allogeneic haematopoietic stem cell transplantation (alloHCT) and is a detrimental condition with a high mortality rate. Systemic steroid therapy is generally the first line of treatment for aGvHD. According to a study by Malard and colleagues, which was published in Nature in 2020, approximately 35-50% of patients develop systemic-refractory acute graft-versus-host disease (SR-aGvHD). Furthermore, an optimal second-line therapy has not yet been introduced, highlighting the significant need for researchers to develop a safe and effective novel therapy for patients with SR-aGvHD. Cell therapies are a fundamental aspect of regenerative medicine and consist of the administration of living cellular material into a patient to replace or regenerate damaged tissue for functional restoration. There are a variety of cells used within cell therapy, including embryonic stem cells (ESCs), induced pluripotent stem cells, and MSCs. MSCs are stromal cells that exhibit self-renewal and multipotent properties with the capacity to differentiate along mesenchymal and non-mesenchymal lineages. These include osteoblasts, myocytes, adipocytes, and chondrocytes. MSCs can be isolated from various tissues, including bone marrow, cord cells, and molar cells, and pose fewer ethical concerns compared to those associated with the collection of ESCs. SR-Ryoncil was developed and patented by Osiris Therapeutics, which later sold the intellectual property to Mesoblast Limited to initiate Phase III trials. In a single-arm, multi-centre, Phase III trial in children with SR-aGvHD, 89% of which had a severe form of the disease, 70% of children achieved an overall response by Day 28 of treatment using Ryoncil. This measure predicts the survival rates of patients with aGvHD. According to leading data and analytics company GlobalData's Making a Difference with Regenerative Medicine, 2025 report, allogeneic cell therapies have the potential to reduce manufacturing burdens within the pharmaceutical industry. This is due to their advantageous scalability in comparison to autologous treatments as multiple patients can be treated from a single batch, consequently increasing patient accessibility. However, the usage of allogeneic cell therapies exhibits a variety of challenges. For example, larger batches of allogeneic cells create difficulties in preserving cell consistencies, requiring advanced bioprocessing techniques and intricate machinery. Furthermore, the regulatory landscape for allogeneic cell therapies presents complex procedures due to their relative novelty in comparison to autologous treatments. The multipotent characteristics of MSCs have the potential to expand into multiple clinical developments and fulfil the unmet medical demand of various diseases. As the number of patients with alloHCT increases, the development of novel and alternative means of regenerative therapy becomes increasingly important within the pharmaceutical landscape. This highlights the potential of Ryoncil's immunomodulatory effects for the treatment of SR-aGvHD while simultaneously advancing therapeutic applications for other inflammatory diseases, thus allowing researchers to utilise MSC-based therapy options to ultimately improve patient outcomes. "Ryoncil, the first FDA-approved mesenchymal stromal cell therapy" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
