Latest news with #PDCO
Yahoo
12-08-2025
- Business
- Yahoo
Airway Therapeutics Receives European Medicines Agency Pediatric Committee Approval for Zelpultide Alfa's Study Plan in Bronchopulmonary Dysplasia for Very Preterm Infants
Multinational Phase 2b dose selection and Phase 3 expansion study for zelpultide alfa set to begin in late Q3/Q4 2025 MARIETTA, Ga., Aug. 12, 2025 /CNW/ -- Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious diseases, today announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved its Pediatric Investigation Plan (PIP) for its investigational biologic, zelpultide alfa, in its initial indication for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks gestational age. Zelpultide alfa is a first-in-class recombinant human surfactant protein D (rhSP-D) designed to modulate immune responses to reduce inflammation, enhance pathogen clearance, and support surfactant homeostasis for improved lung function. "We are pleased to have reached agreement with the PDCO on the Pediatric Investigation Plan and pivotal study design for zelpultide alfa, a ground-breaking therapy being developed to prevent BPD in very preterm infants, a highly vulnerable population with no approved preventative treatments," said Dr. Marc Salzberg, Chairman, Chief Executive & Medical Officer of Airway Therapeutics. "This marks a significant milestone in advancing a potential first-in-class preventive therapy to improve outcomes for these fragile infants and address a critical unmet medical need." The approved PIP includes the design and execution plan for a pivotal Phase 2b/3 clinical trial. The Phase 2b trial will evaluate two different dose levels of zelpultide alfa administered for up to seven days, compared to placebo. Following completion of treatment in 150 patients (50 per arm), one dose will be selected for continuation into Phase 3, during which approximately 216 additional patients will be enrolled. As part of the study, Airway Therapeutics will assess a three-day consecutive BPD evaluation endpoint, which may contribute to the development of improved outcome measures during the studies. "Bronchopulmonary dysplasia remains one of the most challenging complications in neonatal intensive care, with long-term consequences for respiratory and neurodevelopmental outcomes," said Dr. Daniele De Luca, Principal Investigator of the trial and Professor of Pediatrics (Neonatology) at Paris Saclay University. "Zelpultide alfa represents a novel and scientifically promising approach, grounded in our understanding of immune modulation and tissue injury. This study will allow us to rigorously evaluate its potential to change clinical practice by addressing the root drivers of lung injury in very preterm infants." Airway Therapeutics plans to submit the PDCO-approved protocol immediately to health authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH), with the objective of initiating the clinical trial in these countries in late Q3 or Q4 2025. Additional submissions will follow in France, Germany, Belgium, and Poland, along with planned regulatory filings in Argentina, Australia, and the United States. About Zelpultide Alfa Zelpultide alfa is a recombinant human surfactant protein D (rhSP-D) precisely engineered to replicate the native protein's full quaternary structure and biological function, incorporating optimized glycosylation through advanced cell line technology. Its therapeutic activity is driven by three key mechanisms: modulation of immune responses to mitigate excessive inflammation, enhancement of pathogen recognition and clearance, and maintenance of surfactant homeostasis to support pulmonary function. As a versatile biologic platform, zelpultide alfa is being developed for patients across all age groups—from preventing bronchopulmonary dysplasia (BPD) in very preterm infants to treating acute and chronic respiratory, inflammatory and infectious conditions in adults. Zelpultide alfa's lead indication, BPD prevention, is currently progressing through a pivotal Phase 2b/3 clinical trial, following Phase 1 study that demonstrated a favorable safety and tolerability profile. About Airway Therapeutics Airway Therapeutics is a clinical-stage biopharmaceutical company developing a new class of biologic therapies to redefine the prevention and treatment of respiratory, inflammatory, and infectious diseases. Its lead candidate, zelpultide alfa, is currently in late-stage clinical development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants, a condition with no approved preventive therapies. As a platform biologic, zelpultide alfa is also being advanced for broader application across age groups and disease settings, with the goal of improving outcomes for vulnerable patient populations. For more information, please visit Company Contact:Libba MuziAirway Therapeuticsmuzi@ Media Contact:Tony Russo, Ph.D. Russo Partners, View original content to download multimedia: SOURCE Airway Therapeutics View original content to download multimedia:
Cision Canada
12-08-2025
- Business
- Cision Canada
Airway Therapeutics Receives European Medicines Agency Pediatric Committee Approval for Zelpultide Alfa's Study Plan in Bronchopulmonary Dysplasia for Very Preterm Infants
Multinational Phase 2b dose selection and Phase 3 expansion study for zelpultide alfa set to begin in late Q3/Q4 2025 MARIETTA, Ga., Aug. 12, 2025 /CNW/ -- Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious diseases, today announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved its Pediatric Investigation Plan (PIP) for its investigational biologic, zelpultide alfa, in its initial indication for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks gestational age. Zelpultide alfa is a first-in-class recombinant human surfactant protein D (rhSP-D) designed to modulate immune responses to reduce inflammation, enhance pathogen clearance, and support surfactant homeostasis for improved lung function. "We are pleased to have reached agreement with the PDCO on the Pediatric Investigation Plan and pivotal study design for zelpultide alfa, a ground-breaking therapy being developed to prevent BPD in very preterm infants, a highly vulnerable population with no approved preventative treatments," said Dr. Marc Salzberg, Chairman, Chief Executive & Medical Officer of Airway Therapeutics. "This marks a significant milestone in advancing a potential first-in-class preventive therapy to improve outcomes for these fragile infants and address a critical unmet medical need." The approved PIP includes the design and execution plan for a pivotal Phase 2b/3 clinical trial. The Phase 2b trial will evaluate two different dose levels of zelpultide alfa administered for up to seven days, compared to placebo. Following completion of treatment in 150 patients (50 per arm), one dose will be selected for continuation into Phase 3, during which approximately 216 additional patients will be enrolled. As part of the study, Airway Therapeutics will assess a three-day consecutive BPD evaluation endpoint, which may contribute to the development of improved outcome measures during the studies. "Bronchopulmonary dysplasia remains one of the most challenging complications in neonatal intensive care, with long-term consequences for respiratory and neurodevelopmental outcomes," said Dr. Daniele De Luca, Principal Investigator of the trial and Professor of Pediatrics (Neonatology) at Paris Saclay University. "Zelpultide alfa represents a novel and scientifically promising approach, grounded in our understanding of immune modulation and tissue injury. This study will allow us to rigorously evaluate its potential to change clinical practice by addressing the root drivers of lung injury in very preterm infants." Airway Therapeutics plans to submit the PDCO-approved protocol immediately to health authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH), with the objective of initiating the clinical trial in these countries in late Q3 or Q4 2025. Additional submissions will follow in France, Germany, Belgium, and Poland, along with planned regulatory filings in Argentina, Australia, and the United States. About Zelpultide Alfa Zelpultide alfa is a recombinant human surfactant protein D (rhSP-D) precisely engineered to replicate the native protein's full quaternary structure and biological function, incorporating optimized glycosylation through advanced cell line technology. Its therapeutic activity is driven by three key mechanisms: modulation of immune responses to mitigate excessive inflammation, enhancement of pathogen recognition and clearance, and maintenance of surfactant homeostasis to support pulmonary function. As a versatile biologic platform, zelpultide alfa is being developed for patients across all age groups—from preventing bronchopulmonary dysplasia (BPD) in very preterm infants to treating acute and chronic respiratory, inflammatory and infectious conditions in adults. Zelpultide alfa's lead indication, BPD prevention, is currently progressing through a pivotal Phase 2b/3 clinical trial, following Phase 1 study that demonstrated a favorable safety and tolerability profile. About Airway Therapeutics Airway Therapeutics is a clinical-stage biopharmaceutical company developing a new class of biologic therapies to redefine the prevention and treatment of respiratory, inflammatory, and infectious diseases. Its lead candidate, zelpultide alfa, is currently in late-stage clinical development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants, a condition with no approved preventive therapies. As a platform biologic, zelpultide alfa is also being advanced for broader application across age groups and disease settings, with the goal of improving outcomes for vulnerable patient populations. Company Contact: Libba Muzi Airway Therapeutics [email protected] 513-770-9630 Media Contact: Tony Russo, Ph.D. Russo Partners, LLC [email protected] 212-845-4251 SOURCE Airway Therapeutics
Yahoo
15-05-2025
- Health
- Yahoo
Positive EMA Opinion on Pediatric Investigation Plan for PolTREG's Treg Therapy in Type 1 Diabetes
Positive EMA Opinion on Pediatric Investigation Plan for PolTREG's Treg Therapy in Type 1 Diabetes The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG's Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1). Positive opinion paves the way for potential marketing authorization in the EU and EEA. Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years). In vivo data in murine models confirm preliminary safety and efficacy of CAR-TREG therapy, supporting upcoming Phase 1 clinical trials in multiple sclerosis and amyotrophic lateral sclerosis. Gdańsk, Poland – 15 May 2025 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, announces that the Paediatric Committee (PDCO) of the European Medicines Agency has issued a positive opinion on the Pediatric Investigation Plan (PIP) for its investigational somatic cell therapy product, polyclonal Treg lymphocytes (PTG-007), aimed at preventing symptomatic type 1 diabetes in children. 'Securing a positive opinion from the PDCO brings PolTREG one step closer to the potential approval of PTG-007 for pediatric use across the European Union and the European Economic Area. Achieving the PIP-defined clinical endpoints may serve as the basis for obtaining marketing authorization. Pre-symptomatic type 1 diabetes (Stage 1) represents a significant unmet medical need, making this therapeutic area highly attractive,' said Prof. Piotr Trzonkowski, CEO of PolTREG. 'We are also delighted by the progress in developing next-generation Tregs. The in vivo murine results obtained a few days ago using CAR-TREG lymphocytes shows the preliminary safety and efficacy of our therapy. In the coming months, we will intensively prepare to initiate a Phase 1 clinical trial in multiple sclerosis and amyotrophic lateral sclerosis,' said Prof. Piotr Trzonkowski. The PDCO's positive opinion is based on PolTREG's original preTreg clinical trial protocol initiated in October 2024, which enrolled children aged 6–16 years in Stage 1 type 1 diabetes. In its assessment, the committee has recommended broadening the eligible population to include patients aged 3–18 years. PolTREG combines over 12 years of clinical data confirming the safety and efficacy of polyclonal Treg therapies with a broad portfolio of next-generation technologies, including allogeneic Tregs, CAR-TREGs, antigen-specific Tregs, and TCR-TREGs. PolTREG is the only company with 12 years' worth of patient-safety and efficacy data for autologous polyclonal Treg therapies—data derived from clinical trials and hospital exemptions in Poland. To read more about the clinical trials PolTREG has completed, please click on: In parallel, PolTREG has achieved a major milestone toward its CAR-TREG program, in collaboration with AZTherapies. In vivo studies in murine models demonstrate encouraging preliminary safety and efficacy for CAR-engineered Treg lymphocytes, supporting an application for a Phase 1 clinical trial in multiple sclerosis and Amyotrophic Lateral Sclerosis in the coming months. This cellular product will be further made allogeneic in the cooperation with Swiss-based company Antion manufactures its Treg therapeutics at its own GMP-certified manufacturing facility. It is the first company in the world to have administered Treg therapies to patients, and, under a hospital exemption valid in Poland, the first company to start receiving revenues from a Treg therapeutic for autoimmune disease. Its GMP manufacturing facility is one of Europe's largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines. PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies. It can ship its wide range of cellular therapy products across Europe within 24 hours. About PolTREG PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies. For more information please visit For further information please contact:PolTREG Piotr TrzonkowskiChief Executive Officerir@ 512 532 401 Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
Yahoo
14-05-2025
- Business
- Yahoo
1 Small-Cap Stock for Long-Term Investors and 2 to Be Wary Of
Investors looking for hidden gems should keep an eye on small-cap stocks because they're frequently overlooked by Wall Street. Many opportunities exist in this part of the market, but it is also a high-risk, high-reward environment due to the lack of reliable analyst price targets. These trade-offs can cause headaches for even the most seasoned professionals, which is why we started StockStory - to help you separate the good companies from the bad. That said, here is one small-cap stock that could be the next 100 bagger and two best left ignored. Market Cap: $1.49 billion Operating under multiple brands, National Vision (NYSE:EYE) sells optical products such as eyeglasses and provides optical services such as eye exams. Why Do We Avoid EYE? Store closures are a headwind for growth and suggest it's rightsizing operations to optimize sales at existing locations Operating margin of 0.3% falls short of the industry average, and the smaller profit dollars make it harder to react to unexpected market developments Underwhelming 3% return on capital reflects management's difficulties in finding profitable growth opportunities, and its decreasing returns suggest its historical profit centers are aging National Vision's stock price of $18.86 implies a valuation ratio of 31.2x forward P/E. Read our free research report to see why you should think twice about including EYE in your portfolio, it's free. Market Cap: $2.77 billion With roots dating back to 1877 and serving over 150,000 customers across North America and the UK, Patterson Companies (NASDAQ:PDCO) is a specialty distributor that supplies dental practices and animal health professionals with equipment, consumables, pharmaceuticals, and practice management software. Why Does PDCO Worry Us? Core business is underperforming as its organic revenue has disappointed over the past two years, suggesting it might need acquisitions to stimulate growth Performance over the past five years shows its incremental sales were less profitable as its earnings per share were flat Negative free cash flow raises questions about the return timeline for its investments Patterson Companies is trading at $31.34 per share, or 13.6x forward P/E. Dive into our free research report to see why there are better opportunities than PDCO. Market Cap: $1.05 billion Integrating power outlets into many Boeing aircraft, Astronics (NASDAQ:ATRO) is a provider of technologies and services to the global aerospace, defense, and electronics industries. Why Does ATRO Stand Out? Market share has increased this cycle as its 19.1% annual revenue growth over the last two years was exceptional Incremental sales over the last two years have been highly profitable as its earnings per share increased by 81.3% annually, topping its revenue gains Historical investments are beginning to pay off as its returns on capital are growing At $29.90 per share, Astronics trades at 19.4x forward P/E. Is now the time to initiate a position? Find out in our full research report, it's free. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today for free. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-04-2025
- Business
- Yahoo
3 Dawdling Stocks Walking a Fine Line
Low-volatility stocks may offer stability, but that often comes at the cost of slower growth and the upside potential of more dynamic companies. Luckily for you, StockStory helps you navigate which companies are truly worth holding. Keeping that in mind, here are three low-volatility stocks to steer clear of and a few better alternatives. Rolling One-Year Beta: 0.63 Founded in 1990 in Cincinnati, Ohio, Paycor (NASDAQ: PYCR) provides software for small businesses to manage their payroll and HR needs in one place. Why Does PYCR Worry Us? High servicing costs result in a relatively inferior gross margin of 66% that must be offset through increased usage Poor expense management has led to operating losses Forecasted free cash flow margin suggests the company will fail to improve its cash conversion over the next year Paycor's stock price of $22.49 implies a valuation ratio of 5.2x forward price-to-sales. Check out our free in-depth research report to learn more about why PYCR doesn't pass our bar. Rolling One-Year Beta: 0.76 Formed from a partnership between two distinct companies, CVG (NASDAQ:CVGI) offers various components used in vehicles and systems used in warehouses. Why Do We Think CVGI Will Underperform? Annual sales declines of 2.4% for the past five years show its products and services struggled to connect with the market during this cycle Free cash flow margin shrank by 9.1 percentage points over the last five years, suggesting the company is consuming more capital to stay competitive Limited cash reserves may force the company to seek unfavorable financing terms that could dilute shareholders Commercial Vehicle Group is trading at $0.96 per share, or 10.5x forward price-to-earnings. Read our free research report to see why you should think twice about including CVGI in your portfolio, it's free. Rolling One-Year Beta: 0.35 With roots dating back to 1877 and serving over 150,000 customers across North America and the UK, Patterson Companies (NASDAQ:PDCO) is a specialty distributor that supplies dental practices and animal health professionals with equipment, consumables, pharmaceuticals, and practice management software. Why Are We Hesitant About PDCO? Organic sales performance over the past two years indicates the company may need to make strategic adjustments or rely on M&A to catalyze faster growth Estimated sales growth of 3.1% for the next 12 months is soft and implies weaker demand Cash burn makes us question whether it can achieve sustainable long-term growth At $31.34 per share, Patterson Companies trades at 13.8x forward price-to-earnings. If you're considering PDCO for your portfolio, see our FREE research report to learn more. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 9 Market-Beating Stocks. This is a curated list of our High Quality stocks that have generated a market-beating return of 175% over the last five years. Stocks that made our list in 2019 include now familiar names such as Nvidia (+2,183% between December 2019 and December 2024) as well as under-the-radar businesses like United Rentals (+322% five-year return). Find your next big winner with StockStory today for free. Sign in to access your portfolio
