Latest news with #TransCon
Yahoo
a day ago
- Business
- Yahoo
TransCon® hGH Boosts TransCon® CNP Results in Kids with Achondroplasia by Week 26
Ascendis Pharma A/S (NASDAQ:ASND) is among the 13 Biotech Stocks with Huge Upside Potential. It reported interim Week 26 data from its Phase 2 COACH Trial, confirming that combining TransCon hGH (lonapegsomatropin) with TransCon CNP (navepegritide) raised annualized growth velocity (AGV) and height Z-scores in children with achondroplasia. A close-up view of a hand manipulating a syringe while delivering TransCon CNP into a tumor. A mean AGV of 9.14 cm/year and a +0.53 Z-score rise were attained by treatment-naïve youngsters (N=12). Children (N=9) treated with TransCon CNP in the past achieved an AGV of 8.25 cm/year with a +0.44 Z-score improvement. The majority of side effects were modest, and safety remained consistent with monotherapies. The COACH Trial is the first to assess this combination in kids between the ages of two and eleven. While TransCon CNP is undergoing FDA priority review, TransCon hGH is approved as SKYTROFA® for juvenile growth hormone insufficiency. The treatment focuses on the FGFR3-CNP signaling imbalance that is at the heart of achondroplasia, a disorder that affects more than 250,000 people worldwide. It is anticipated that the results of week 52 and a scheduled Phase 3 trial in Q4 2025 will further clarify efficacy and long-term benefits. The biopharmaceutical business Ascendis Pharma A/S (NASDAQ:ASND) uses its TransCon technology platform to significantly improve patient outcomes. While we acknowledge the potential of ASND 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: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None.
Yahoo
24-04-2025
- Business
- Yahoo
Ascendis Pharma to Report First Quarter 2025 Financial Results and Provide Business Update on May 1, 2025
COPENHAGEN, Denmark, April 24, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report first quarter 2025 financial results and provide a business update on Thursday, May 1, 2025, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on May 1, 2025, at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2025 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at A replay of the webcast will be available on this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days. About Ascendis Pharma A/SAscendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit to learn more. Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis' future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis' ability to apply its TransCon technology platform to make a meaningful difference for patients and (ii) Ascendis' application of TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis' products and product candidates; unforeseen safety or efficacy results in Ascendis' development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis' development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis' business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis' ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see Ascendis' Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis' other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. © April 2025 Ascendis Pharma A/S. Investor Contacts: Media Contact: Scott Smith Melinda Baker Ascendis Pharma Ascendis Pharma ir@ media@ Patti Bank ICR Healthcare +1 (415) 513-1284
Yahoo
03-03-2025
- Business
- Yahoo
Exploring US High Growth Tech Stocks In March 2025
Over the last 7 days, the United States market has experienced a slight decline of 1.3%, yet it has shown resilience with a 15% increase over the past year and earnings forecast to grow by 14% annually. In this dynamic environment, identifying high growth tech stocks involves looking for companies that demonstrate strong innovation potential and adaptability to sustain growth amidst fluctuating market conditions. Name Revenue Growth Earnings Growth Growth Rating Super Micro Computer 25.26% 29.10% ★★★★★★ AsiaFIN Holdings 51.75% 82.69% ★★★★★★ Travere Therapeutics 28.43% 65.01% ★★★★★★ Alkami Technology 20.94% 85.17% ★★★★★★ AVITA Medical 27.78% 55.33% ★★★★★★ TG Therapeutics 29.48% 45.20% ★★★★★★ Clene 61.16% 59.11% ★★★★★★ Alnylam Pharmaceuticals 22.90% 58.64% ★★★★★★ Zai Lab 28.84% 67.49% ★★★★★★ Lumentum Holdings 21.24% 119.37% ★★★★★★ Click here to see the full list of 236 stocks from our US High Growth Tech and AI Stocks screener. Let's uncover some gems from our specialized screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative treatments for rare diseases, with a market cap of $2.23 billion. Operations: Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases. As a clinical-stage biopharmaceutical company, it is currently not generating revenue from its operations. Soleno Therapeutics, despite its recent financial challenges marked by a net loss of $175.85 million for the year, remains a focal point in biotech due to its aggressive R&D initiatives and anticipated revenue growth. The company's strategic maneuvers, including a significant shelf registration of $82.25 million and securing a $200 million loan for advancing Prader-Willi syndrome treatments, underscore its commitment to innovation and market expansion. With an expected annual revenue increase of 49.4%, Soleno is positioning itself strategically within the high-growth biotech sector, aiming to leverage R&D breakthroughs into commercial success in the coming years. Dive into the specifics of Soleno Therapeutics here with our thorough health report. Learn about Soleno Therapeutics' historical performance. Simply Wall St Growth Rating: ★★★★★☆ Overview: Ascendis Pharma A/S is a biopharmaceutical company that develops TransCon-based therapies for unmet medical needs across Denmark, Europe, North America, and internationally, with a market cap of $9.37 billion. Operations: Ascendis Pharma generates revenue primarily from its biotechnology segment, amounting to €363.64 million. The company's focus is on developing therapies using its proprietary TransCon technology platform. Ascendis Pharma has demonstrated resilience and strategic foresight in the high-growth biotech landscape, marked by a notable 32.5% annual revenue growth and a reduction in net loss from EUR 481.45 million to EUR 378.08 million year-over-year. The company's recent shelf registration of $108 million underscores its proactive approach to funding future innovations, while its R&D commitment is evident from the substantial advancements in its TransCon technology platforms, promising enhanced treatment efficacy across multiple therapeutic areas. Moreover, Ascendis' recent share repurchase program highlights confidence in its financial health and future prospects, positioning it as a dynamic player amidst challenging market conditions and ongoing patent disputes with competitors like BioMarin. Get an in-depth perspective on Ascendis Pharma's performance by reading our health report here. Gain insights into Ascendis Pharma's historical performance by reviewing our past performance report. Simply Wall St Growth Rating: ★★★★★☆ Overview: ServiceNow, Inc. offers cloud-based solutions for digital workflows across various regions globally and has a market capitalization of $191.53 billion. Operations: The company generates revenue primarily from its Internet Software & Services segment, amounting to $10.98 billion. ServiceNow, a leader in digital workflow solutions, is capitalizing on the AI-driven transformation across industries. With a robust 15.2% annual revenue growth and an impressive 20.6% forecast in earnings growth, the company is setting benchmarks in integrating AI to enhance operational efficiencies. Recently, ServiceNow introduced AI agents for telecoms, developed with NVIDIA's cutting-edge technology, aimed at automating complex customer service and network operations workflows. This innovation not only underscores ServiceNow's commitment to R&D (spending significant portions of its $10.98 billion revenue on these initiatives) but also positions it strategically within a sector poised for substantial growth due to AI adoption. Click to explore a detailed breakdown of our findings in ServiceNow's health report. Assess ServiceNow's past performance with our detailed historical performance reports. Investigate our full lineup of 236 US High Growth Tech and AI Stocks right here. Already own these companies? Bring clarity to your investment decisions by linking up your portfolio with Simply Wall St, where you can monitor all the vital signs of your stocks effortlessly. Discover a world of investment opportunities with Simply Wall St's free app and access unparalleled stock analysis across all markets. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. 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:SLNO NasdaqGS:ASND and NYSE:NOW. Have feedback on this article? Concerned about the content? with us directly. 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Yahoo
24-02-2025
- Business
- Yahoo
Ascendis Pharma to Participate in the TD Cowen 45th Annual Health Care Conference
COPENHAGEN, Denmark, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025, at 11:10 a.m. Eastern Time / 8:10 a.m. Pacific Time in Boston, Massachusetts. A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at A webcast replay will also be available on this website shortly after conclusion of the event for 30 days. About Ascendis Pharma A/SAscendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis' future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis' ability to apply its innovative TransCon technology platform to build a leading, fully integrated biopharma company, and (ii) Ascendis' use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis' products and product candidates; unforeseen safety or efficacy results in Ascendis' development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis' development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis' business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis' ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see Ascendis' Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis' other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group. © February 2025 Ascendis Pharma A/S. Investor Contacts:Scott SmithAscendis Pharmair@ Media Contact:Melinda BakerAscendis Pharma+1 (650) 709-8875media@ Patti BankICR Healthcare+1 (415)
Yahoo
14-02-2025
- Business
- Yahoo
Ascendis Pharma AS (ASND) Q4 2024 Earnings Call Highlights: Strategic Growth and Market ...
Release Date: February 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Ascendis Pharma AS (NASDAQ:ASND) achieved significant milestones in 2024, setting the stage for strong growth and value creation. Skytrofa has established itself as a high-value growth hormone brand, capturing a 6.5% market share in the US. Transcon PTH, the only FDA-approved treatment for hypoparathyroidism in adults, has launched in the US and is gaining traction as a new standard of care. The company has a strong financial position with cash equivalents totaling 665 million, including a 100 million upfront payment from Novo Nordisk. Ascendis Pharma AS (NASDAQ:ASND) is expanding its TransCon technology platform beyond endocrine diseases, exploring opportunities in metabolic and cardiovascular diseases. Revenue for Skytrofa in Q4 2024 was lower than the same period in 2023, despite volume growth. The company faces challenges in establishing insurance reimbursement policies for new products like Yorvipa. There is uncertainty regarding the timeline for insurance approvals, which are estimated to take 4 to 8 weeks. Operating expenses increased by 3% in Q4 2024 compared to the previous year, driven by higher employee and commercial costs. The company has not provided specific sales guidance for Yorvipa, creating uncertainty about future financial performance. Warning! GuruFocus has detected 2 Warning Sign with ASND. Q: Can you confirm that the 908 figure is unique patients and not cumulative scripts, including refills? Also, how many of the EAP and OLE rollover patients are included in that 908 number? Lastly, are insurance approvals taking 4 to 8 weeks as expected? A: Yes, the 908 figure represents unique patient enrollments, not cumulative scripts. About 20% of the 908 are existing patients from Transcon PTH EAP or clinical trials, and 80% are new to Yorvipa. Regarding insurance approvals, 4 to 8 weeks is our estimate, but since the drug has been on the market for a short time, we need more time to confirm this timeframe. Q: Can you provide the Yorvipa patient number outside the US? A: We have not broken down the numbers outside the US yet. We are still in the early stages of commercial availability in Europe, with full commercial launches in Germany and Austria, and a non-promotional program in France. Patient numbers are increasing as expected. Q: How many of the 908 scripts have been converted to patients on actual therapy, and what proportion of these patients had previous experience with Natpara? A: We don't have all the information yet to provide a concrete answer. However, based on our market research, many of the patients are likely coming from the group we define as uncontrolled on standard therapy. We are still in the initial phase of getting patients fully reimbursed. Q: Are you considering providing sales guidance for Yorvipa for the full year sometime in the middle of the year? A: We would like to provide guidance when we are confident in the numbers. Depending on how the launch progresses and how different regions perform, we will provide revenue guidance when we feel confident. Q: How have discussions with payers gone so far for Yorvipa, and what are your assumptions for prior authorization criteria? A: Discussions with payers have been productive, focusing on the clinical value proposition of the drug. We expect prior authorization criteria to be consistent with the label, both in terms of reauthorization timelines and necessary tests. While many policies are still being established, we are encouraged by the conversations. Q: Can you provide insights on the titration process for Yorvipa in the real world? A: Endocrinologists are familiar with titrating medications, and they have found the process straightforward. We provide guidance as needed, especially when switching between different dose pens. Anecdotally, endocrinologists are comfortable with the titration process. Q: Are you planning any run-in activities for the hypochondroplasia program to help accelerate the timing of the study and enrollment? A: We are still determining the best pathway forward for hypochondroplasia, whether it will be a standalone Transcon CNP treatment or a combination with Transcon Growth Hormone. We are actively discussing with agencies and considering the unique phenotype of hypochondroplasia to find the best regulatory path forward. Q: How should we think about the capacity to meet the increasing demand for Yorvipa throughout the year? A: We have a robust supply chain in place, similar to what we use for other products like Skytrofa. We closely monitor inventory levels and are committed to ensuring there is no shortage of supply. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
