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Business Wire
2 days ago
- Business Wire
Savara to Present New Data from the Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the European Respiratory Society Congress 2025
LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced the acceptance of three abstracts for poster presentation at the European Respiratory Society (ERS) Congress 2025, September 27 – October 1, Amsterdam, The Netherlands. The Company will also host an Industry Evening Mini Symposium titled 'Advances in Autoimmune Pulmonary Alveolar Proteinosis' at the meeting. ERS Congress 2025 Posters & Industry Symposium Savara Poster Title: Relationship Between Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life (HRQoL), Exercise Capacity, and Surfactant Burden in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: PS-37 / Interstitial Lung Diseases / Respiratory Critical Care / Alveolar Filling Disorders and Autoimmune Lung Diseases Date/Time of Poster Discussion Session: Poster Number: PA3027 Location: RAI Amsterdam, Netherlands Presenter: Francesco Bonella, M.D., Ph.D., Head of the Center for Interstitial and Rare Lung Diseases and Assistant Professor, Ruhrlandklinik University Hospital, Essen, Germany Poster Title: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: PS-37 / Interstitial Lung Diseases / Respiratory Critical Care / Alveolar Filling Disorders and Autoimmune Lung Diseases Date/Time of Poster Presentation Session: Monday, September 29, 2025, 8:00 - 9:30 CEST Poster Number: PA3026 Location: RAI Amsterdam, Netherlands Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at the University College Dublin (UCD) and Consultant Respiratory Physician, St. Vincent's University Hospital, Dublin, Ireland TrilliumBiO Poster Title: Development of a Dried Serum Assay for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Session Title: PS-37 / Interstitial Lung Diseases / Respiratory Critical Care / Alveolar Filling Disorders and Autoimmune Lung Diseases Date/Time of Poster Presentation Session: Monday, September 29, 2025, 8:00 - 9:30 CEST Poster Number PA3025 Location: RAI Amsterdam, Netherlands Presenter: Eagappanath Thiruppathi, Ph.D., Director of Test and Method Development, TrilliumBiO Savara Industry Evening Mini Symposium Title: Advances in Autoimmune Pulmonary Alveolar Proteinosis Date/Time: Monday, September 29, 2025, 17:30 - 19:00 CEST Description: Effrosyni D. Manali, M.D., Ph.D., Maria Molina-Molina, M.D., Ph.D., and Maria Kokosi, M.D. will provide an update on autoimmune pulmonary alveolar proteinosis, including the pathophysiology of this rare lung disease, its signs and symptoms, burden of illness, and diagnosis and management of the disease. Chair: Brian Robinson, M.D, Executive Vice President, Global Medical Affairs, Savara Inc. Location: E102, RAI Amsterdam Presenters: Effrosyni D. Manali, M.D., Ph.D.: 2nd Pulmonary Medicine Department, General University Hospital 'Attikon,' Medical School, National and Kapodistrian University of Athens, Athens, Greece; Maria Molina-Molina, M.D., Ph.D.: Interstitial Lung Diseases Unit, Hospital Universitario de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, CIBERES, Spain; Maria Kokosi, M.D.: Guy's and St. Thomas' NHS Foundation Trust, Royal Brompton Hospital, London, UK Following the sessions, the posters will be available on the Congresses & Publications page of the Company's corporate website. Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn.
Yahoo
4 days ago
- Yahoo
Is There An Opportunity With Equifax Inc.'s (NYSE:EFX) 20% Undervaluation?
Key Insights Using the 2 Stage Free Cash Flow to Equity, Equifax fair value estimate is US$311 Equifax's US$248 share price signals that it might be 20% undervalued Analyst price target for EFX is US$281 which is 9.8% below our fair value estimate Today we will run through one way of estimating the intrinsic value of Equifax Inc. (NYSE:EFX) by taking the forecast future cash flows of the company and discounting them back to today's value. The Discounted Cash Flow (DCF) model is the tool we will apply to do this. It may sound complicated, but actually it is quite simple! Companies can be valued in a lot of ways, so we would point out that a DCF is not perfect for every situation. If you want to learn more about discounted cash flow, the rationale behind this calculation can be read in detail in the Simply Wall St analysis model. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. Is Equifax Fairly Valued? We are going to use a two-stage DCF model, which, as the name states, takes into account two stages of growth. The first stage is generally a higher growth period which levels off heading towards the terminal value, captured in the second 'steady growth' period. To begin with, we have to get estimates of the next ten years of cash flows. Where possible we use analyst estimates, but when these aren't available we extrapolate the previous free cash flow (FCF) from the last estimate or reported value. We assume companies with shrinking free cash flow will slow their rate of shrinkage, and that companies with growing free cash flow will see their growth rate slow, over this period. We do this to reflect that growth tends to slow more in the early years than it does in later years. A DCF is all about the idea that a dollar in the future is less valuable than a dollar today, so we discount the value of these future cash flows to their estimated value in today's dollars: 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 Levered FCF ($, Millions) US$1.18b US$1.47b US$1.90b US$1.90b US$1.92b US$1.95b US$1.99b US$2.03b US$2.08b US$2.14b Growth Rate Estimate Source Analyst x7 Analyst x6 Analyst x1 Analyst x1 Est @ 0.92% Est @ 1.57% Est @ 2.02% Est @ 2.34% Est @ 2.56% Est @ 2.72% Present Value ($, Millions) Discounted @ 7.3% US$1.1k US$1.3k US$1.5k US$1.4k US$1.3k US$1.3k US$1.2k US$1.2k US$1.1k US$1.1k ("Est" = FCF growth rate estimated by Simply Wall St)Present Value of 10-year Cash Flow (PVCF) = US$13b The second stage is also known as Terminal Value, this is the business's cash flow after the first stage. The Gordon Growth formula is used to calculate Terminal Value at a future annual growth rate equal to the 5-year average of the 10-year government bond yield of 3.1%. We discount the terminal cash flows to today's value at a cost of equity of 7.3%. Terminal Value (TV)= FCF2035 × (1 + g) ÷ (r – g) = US$2.1b× (1 + 3.1%) ÷ (7.3%– 3.1%) = US$53b Present Value of Terminal Value (PVTV)= TV / (1 + r)10= US$53b÷ ( 1 + 7.3%)10= US$26b The total value, or equity value, is then the sum of the present value of the future cash flows, which in this case is US$39b. In the final step we divide the equity value by the number of shares outstanding. Relative to the current share price of US$248, the company appears a touch undervalued at a 20% discount to where the stock price trades currently. Remember though, that this is just an approximate valuation, and like any complex formula - garbage in, garbage out. Important Assumptions Now the most important inputs to a discounted cash flow are the discount rate, and of course, the actual cash flows. Part of investing is coming up with your own evaluation of a company's future performance, so try the calculation yourself and check your own assumptions. The DCF also does not consider the possible cyclicality of an industry, or a company's future capital requirements, so it does not give a full picture of a company's potential performance. Given that we are looking at Equifax as potential shareholders, the cost of equity is used as the discount rate, rather than the cost of capital (or weighted average cost of capital, WACC) which accounts for debt. In this calculation we've used 7.3%, which is based on a levered beta of 0.909. Beta is a measure of a stock's volatility, compared to the market as a whole. We get our beta from the industry average beta of globally comparable companies, with an imposed limit between 0.8 and 2.0, which is a reasonable range for a stable business. Check out our latest analysis for Equifax SWOT Analysis for Equifax Strength Earnings growth over the past year exceeded its 5-year average. Debt is well covered by earnings and cashflows. Dividends are covered by earnings and cash flows. Weakness Earnings growth over the past year underperformed the Professional Services industry. Dividend is low compared to the top 25% of dividend payers in the Professional Services market. Opportunity Annual earnings are forecast to grow faster than the American market. Trading below our estimate of fair value by more than 20%. Threat Annual revenue is forecast to grow slower than the American market. Looking Ahead: Although the valuation of a company is important, it is only one of many factors that you need to assess for a company. It's not possible to obtain a foolproof valuation with a DCF model. Preferably you'd apply different cases and assumptions and see how they would impact the company's valuation. For instance, if the terminal value growth rate is adjusted slightly, it can dramatically alter the overall result. Why is the intrinsic value higher than the current share price? For Equifax, there are three fundamental items you should look at: Risks: Take risks, for example - Equifax has 1 warning sign we think you should be aware of. Future Earnings: How does EFX's growth rate compare to its peers and the wider market? Dig deeper into the analyst consensus number for the upcoming years by interacting with our free analyst growth expectation chart. Other Solid Businesses: Low debt, high returns on equity and good past performance are fundamental to a strong business. Why not explore our interactive list of stocks with solid business fundamentals to see if there are other companies you may not have considered! PS. Simply Wall St updates its DCF calculation for every American stock every day, so if you want to find the intrinsic value of any other stock just search here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) 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. Sign in to access your portfolio
Business Insider
5 days ago
- Business Insider
Akero Therapeutics' efruxifermin shows efficacy in Phase 2b MASH, fibrosis trial
Akero Therapeutics (AKRO) announced publication of 96-week final results from the Phase 2b HARMONY trial in The Lancet in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis – MASH – and moderate or advanced fibrosis. Continued treatment with EFX from 24 to 96 weeks resulted in more participants exhibiting improvements in fibrosis and MASH, such that there was near complete reversal of disease in almost one-third of participants treated with the 50mg dose of EFX. In the modified intent-to-treat population at week 96, 49% of participants who received 50mg EFX achieved at least one stage fibrosis improvement without worsening of MASH evaluated by liver histology – the primary endpoint -, vs. 19% for placebo. The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX in the mITT population at week 96, vs. 19% for placebo. A composite endpoint of both MASH resolution and greater than or equal to1-stage fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX treatment groups, respectively, vs. 7% for placebo. EFX was generally well tolerated, with a safety profile consistent with previous trials. Confirmation of these potential benefits of EFX is being evaluated in the ongoing Phase 3 SYNCHRONY clinical trial program. Elevate Your Investing Strategy:
