Latest news with #Ryoncil®
Yahoo
15-05-2025
- Business
- Yahoo
FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil®
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This period of statutory exclusivity means that the FDA will not approve another mesenchymal stromal or stem cell (MSC) products for this indication during the 7-year period from the approval of Ryoncil®. Separately, Mesoblast has biologic exclusivity preventing another sponsor from referencing the Ryoncil® biologic license application (BLA) until December 2036, twelve years from its first approval which would prevent market entry by a biosimilar. These statutory exclusivities are in addition to Mesoblast's strong U.S. intellectual property position on MSC composition of matter, manufacturing and indications, including SR-aGvHD, that provide a commercial barrier to entry against competitors through 2044. 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 2044 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 Twitter: @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
12-02-2025
- Business
- Yahoo
Domino's Pizza Enterprises And 2 Other ASX Stocks That Might Be Trading Below Fair Value
The Australian market has recently shown positive momentum, with the ASX200 closing up 0.6% at 8,535 points, driven by strong performances in the Industrials and Financials sectors. As investors navigate these shifting landscapes, identifying undervalued stocks like Domino's Pizza Enterprises and others could offer potential opportunities for those seeking value in a buoyant yet selective market environment. Name Current Price Fair Value (Est) Discount (Est) IDP Education (ASX:IEL) A$12.38 A$24.32 49.1% COSOL (ASX:COS) A$1.00 A$1.92 47.8% Atlas Arteria (ASX:ALX) A$5.00 A$9.11 45.1% Symal Group (ASX:SYL) A$1.98 A$3.62 45.2% Mesoblast (ASX:MSB) A$2.97 A$5.70 47.9% ReadyTech Holdings (ASX:RDY) A$3.17 A$5.73 44.7% 29Metals (ASX:29M) A$0.195 A$0.39 49.9% Integral Diagnostics (ASX:IDX) A$2.92 A$5.74 49.1% Pantoro (ASX:PNR) A$0.135 A$0.25 47% Sandfire Resources (ASX:SFR) A$10.54 A$19.34 45.5% Click here to see the full list of 54 stocks from our Undervalued ASX Stocks Based On Cash Flows screener. Let's dive into some prime choices out of the screener. Overview: Domino's Pizza Enterprises Limited operates retail food outlets and has a market cap of A$3.21 billion. Operations: The company's revenue from its restaurants segment is A$2.38 billion. Estimated Discount To Fair Value: 37.3% Domino's Pizza Enterprises is trading at A$33.35, significantly below its estimated fair value of A$53.18, indicating potential undervaluation based on cash flows. Although revenue growth is modest at 3.8% annually, earnings are expected to grow significantly by 24.1% per year over the next three years, outpacing the broader Australian market's growth rate of 12.3%. However, a high debt level and an unsustainable dividend coverage may pose challenges despite strong profit forecasts and a high future return on equity of 26.2%. The analysis detailed in our Domino's Pizza Enterprises growth report hints at robust future financial performance. Get an in-depth perspective on Domino's Pizza Enterprises' balance sheet by reading our health report here. Overview: Mesoblast Limited is involved in the development of regenerative medicine products across Australia, the United States, Singapore, and Switzerland, with a market cap of A$3.78 billion. Operations: The company generates revenue from the development of its cell technology platform for commercialization, amounting to $5.90 million. Estimated Discount To Fair Value: 47.9% Mesoblast, trading at A$2.97, is significantly undervalued compared to its fair value estimate of A$5.7. Despite recent shareholder dilution and volatile share prices, the company shows promising prospects with expected annual revenue growth of 49% and anticipated profitability within three years. Recent developments include the U.S. commercial launch of Ryoncil® for pediatric SR-aGvHD, targeting a market exceeding $1 billion annually, supported by a robust balance sheet and strategic cash management amid ongoing equity offerings totaling AUD 260 million. Our earnings growth report unveils the potential for significant increases in Mesoblast's future results. Delve into the full analysis health report here for a deeper understanding of Mesoblast. Overview: Nick Scali Limited, with a market cap of A$1.46 billion, is involved in the sourcing and retailing of household furniture and related accessories across Australia, the United Kingdom, and New Zealand. Operations: The company's revenue is primarily derived from the retailing of furniture, amounting to A$492.63 million. Estimated Discount To Fair Value: 44.3% Nick Scali, trading at A$16.86, is undervalued based on its discounted cash flow valuation, with a fair value estimate of A$30.28. Despite a decrease in interim dividend to 30 cents per share from 35 cents last year and lower net income of A$30.04 million compared to A$43.01 million previously, it remains attractive due to forecasted earnings growth of 12.61% annually and strong return on equity projections reaching 28.5% in three years. In light of our recent growth report, it seems possible that Nick Scali's financial performance will exceed current levels. Take a closer look at Nick Scali's balance sheet health here in our report. Dive into all 54 of the Undervalued ASX Stocks Based On Cash Flows we have identified here. Got skin in the game with these stocks? Elevate how you manage them by using Simply Wall St's portfolio, where intuitive tools await to help optimize your investment outcomes. Maximize your investment potential with Simply Wall St, the comprehensive app that offers global market insights for free. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. 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 ASX:DMP ASX:MSB and ASX:NCK. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
