Ascendis Pharma(ASND)
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Ascendis Pharma(ASND) - 2025 Q3 - Quarterly Report
2025-11-12 21:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO SECTION 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November, 2025 Commission File Number: 001-36815 Ascendis Pharma A/S (Exact Name of Registrant as Specified in Its Charter) Tuborg Boulevard 12 DK-2900 Hellerup Denmark (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover ...
Ascendis Pharma Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-12 21:01
Core Insights - Ascendis Pharma reported Q3 2025 revenue of €213.6 million, a significant increase from €57.8 million in Q3 2024, driven primarily by the strong performance of YORVIPATH and SKYTROFA [6][12] - The company is progressing towards its Vision 2030 goals, with ongoing global launches and positive feedback from healthcare providers and patients [2][4] - Ascendis Pharma achieved an operating profit of €11.0 million in Q3 2025, attributed to higher revenues from YORVIPATH, despite increased operating expenses [11][10] Financial Performance - YORVIPATH revenue for Q3 2025 was €143.1 million, reflecting a negative foreign currency impact of €3.6 million compared to the previous quarter [5][6] - SKYTROFA revenue for Q3 2025 totaled €50.7 million, also impacted by a negative foreign currency effect of €1.6 million [5][6] - Total revenue from commercial products reached €193.8 million in Q3 2025, compared to €55.7 million in Q3 2024 [9][10] Product Development and Regulatory Updates - TransCon CNP is currently under FDA Priority Review for treating children with achondroplasia, with a PDUFA date set for November 30, 2025 [4][8] - The company plans to initiate a Phase 3 trial for TransCon CNP in combination with TransCon hGH following a successful end-of-Phase 2 meeting with the FDA [8][4] - Ascendis Pharma presented new analyses from the ApproaCH Trial at the ASBMR annual meeting, showing improvements in physical functioning for children treated with TransCon CNP [8] Operational Highlights - As of September 30, 2025, Ascendis Pharma had cash and cash equivalents of €539 million, a slight decrease from €560 million at the end of 2024 [13][20] - The company reported a net loss of €61.0 million for Q3 2025, an improvement from a net loss of €99.2 million in Q3 2024 [12][19] - Research and development costs decreased to €66.9 million in Q3 2025 from €73.5 million in the same period in 2024, reflecting the completion of clinical trials [10][19]
Ascendis Pharma Likely To Report Narrower Q3 Loss; These Most Accurate Analysts Revise Forecasts Ahead Of Earnings Call - Ascendis Pharma (NASDAQ:ASND)
Benzinga· 2025-11-12 12:14
Ascendis Pharma A/S (NASDAQ:ASND) will release earnings results for the third quarter, after the closing bell on Wednesday, Nov. 12.Analysts expect the Hellerup, Denmark-based company to report a quarterly loss at 16 cents per share, versus a year-ago loss of $1.72 per share. The consensus estimate for Ascendis Pharma's quarterly revenue is $210.87 million, compared to $57.83 million a year earlier, according to data from Benzinga Pro.On Oct. 8, Ascendis Pharma submitted marketing authorisation application ...
Ascendis Pharma Likely To Report Narrower Q3 Loss; These Most Accurate Analysts Revise Forecasts Ahead Of Earnings Call
Benzinga· 2025-11-12 12:14
Ascendis Pharma A/S (NASDAQ:ASND) will release earnings results for the third quarter, after the closing bell on Wednesday, Nov. 12.Analysts expect the Hellerup, Denmark-based company to report a quarterly loss at 16 cents per share, versus a year-ago loss of $1.72 per share. The consensus estimate for Ascendis Pharma's quarterly revenue is $210.87 million, compared to $57.83 million a year earlier, according to data from Benzinga Pro.On Oct. 8, Ascendis Pharma submitted marketing authorisation application ...
Are These 4 Biotech Stocks Set to Beat Q3 Earnings Estimates?
ZACKS· 2025-11-10 17:25
Core Insights - The third-quarter 2025 reporting cycle for the Medical sector, which includes pharma/biotech and medical device companies, is nearing completion [1] Earnings Performance - Major pharmaceutical companies like Amgen, Novo Nordisk, and Pfizer reported earnings, with Amgen and Pfizer showing strong results and raising their EPS outlook for 2025, while Novo Nordisk faced weaker-than-expected results and reduced its full-year guidance due to slower growth in its GLP-1 portfolio [2] - As of November 5, nearly 82% of companies in the Medical sector, representing 92% of the sector's market capitalization, reported quarterly earnings, with approximately 92% beating earnings estimates and around 84% exceeding revenue expectations. Year-over-year earnings rose over 4%, while revenues increased nearly 11%, with overall expected increases of 3.0% in earnings and 10.5% in sales compared to the previous year [3] Potential Earnings Surprises - Four biotech companies—Alto Neuroscience, Autolus Therapeutics, Ascendis Pharma, and Immuneering—are highlighted as likely to deliver earnings beats based on their positive Earnings ESP and solid Zacks ranks [4][10] - Alto Neuroscience has an Earnings ESP of +16.41% and a Zacks Rank 2, with a consensus estimate for a loss of 66 cents per share [7] - Autolus Therapeutics has an Earnings ESP of +22.30% and a Zacks Rank 2, with a consensus estimate for a loss of 23 cents per share [11] - Ascendis Pharma has an Earnings ESP of +34.28% and a Zacks Rank 3, with a consensus estimate for a loss of 41 cents per share [13] - Immuneering has an Earnings ESP of +21.62% and a Zacks Rank 3, with a consensus estimate for a loss of 37 cents per share [15]
New Pooled 3-Year Analysis Confirms Sustained, Clinically Meaningful Improvements in Renal Function for TransCon® PTH (Palopegteriparatide)-Treated Adults with Hypoparathyroidism
Globenewswire· 2025-11-07 13:30
Core Insights - Ascendis Pharma announced a pooled analysis demonstrating sustained improvements in renal function in adults with hypoparathyroidism treated with TransCon PTH through Year 3 of the Phase 2 PaTH Forward and Phase 3 PaTHway trials [1][2] Group 1: Clinical Trial Results - The pooled analysis included 141 adults with hypoparathyroidism, with 139 patients (mean age 49 years) represented in the analysis [2] - At Year 3, 91% of patients receiving TransCon PTH were independent from conventional therapy, and 84% had normocalcemia [3] - Sustained improvements in eGFR (≥ 5 mL/min/1.73 m²) were observed in 70.3% of patients, with the most significant increases occurring in the first 6 months of treatment [3] Group 2: Safety and Tolerability - TransCon PTH was generally well tolerated, with no new safety signals identified; most treatment-emergent adverse events were mild to moderate [4] - Reductions in 24-hour urinary calcium excretion were maintained within the normal range through Year 3 [4] Group 3: Company Overview and Future Directions - Ascendis Pharma focuses on applying its TransCon technology platform to develop therapies that address unmet medical needs, with TransCon PTH approved as YORVIPATH® for adults with hypoparathyroidism [5][7] - The company aims to continue discussions on the significance of PTH replacement for overall kidney health in patients with hypoparathyroidism [5]
Ascendis Pharma A/S (NASDAQ:ASND) Sees Positive Analyst Sentiment and Growth Prospects
Financial Modeling Prep· 2025-11-06 02:00
Core Insights - Ascendis Pharma A/S is a biopharmaceutical company focused on developing treatments for unmet medical needs, with products like SKYTROFA for growth hormone deficiency (GHD) and ongoing development of other treatments [1] Price Target Trends - The consensus price target for Ascendis Pharma has increased from $221.33 to $254 over the past year, indicating growing optimism among analysts regarding the company's future prospects [2][6] - Despite a lower price target of $161 set by Bank of America Securities analyst Tazeen Ahmad, the overall sentiment remains positive [2] Product Developments - Significant product developments, such as the approval of SKYTROFA for adults with GHD and the Priority Review of TransCon CNP by the U.S. FDA, have likely contributed to the positive analyst sentiment [3][6] - Progress with TransCon Growth Hormone and other treatments is crucial in shaping analyst outlook [3] Market Expansion - Ascendis Pharma's expansion into new markets, including Japan for pediatric GHD, has positively influenced analyst sentiment [4] - The global uptake of YORVIPATH further emphasizes the company's market expansion strategy [4] Financial Performance - In Q2 2025, Ascendis Pharma reported significant revenues of €103 million from YORVIPATH and €50.7 million from SKYTROFA, which likely bolsters analyst confidence in the company's growth potential [5][6] - Successful funding rounds also contribute to the positive trend in price targets [5]
Ascendis Pharma to Report Third Quarter 2025 Financial Results and Provide Business Update on November 12, 2025
Globenewswire· 2025-11-05 21:01
Core Insights - Ascendis Pharma A/S plans to report its third quarter 2025 financial results and provide a business update on November 12, 2025, after U.S. market close [1] - A conference call and live webcast will be held on the same day at 4:30 p.m. Eastern Time to discuss the financial results [1][2] Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on its innovative TransCon technology platform to address unmet medical needs [3] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [3]
3-Year Renal Data in Adults with Hypoparathyroidism Treated with TransCon® PTH (Palopegteriparatide) to Be Shared at Kidney Week 2025
Globenewswire· 2025-11-03 21:01
Core Insights - Ascendis Pharma announced positive data on TransCon PTH, showing sustained improvements in renal function and safety in adults with hypoparathyroidism through Year 3 of the Phase 2 PaTH Forward and Phase 3 PaTHway trials [1][2] - The data will be presented at Kidney Week 2025, aiming to enhance awareness of TransCon PTH and its role in kidney health [2] Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on innovative therapies using its TransCon technology platform, headquartered in Copenhagen, Denmark [4] - The company aims to address unmet medical needs and improve patient outcomes through its product innovations [4] Product Information - TransCon PTH is a prodrug of parathyroid hormone (PTH), designed for once-daily administration to maintain physiological PTH levels for 24 hours [2] - It is approved as YORVIPATH® in the U.S., EU, and EEA for treating adults with hypoparathyroidism [2] Disease Context - Hypoparathyroidism is characterized by insufficient PTH levels, leading to severe complications such as renal issues and neuromuscular irritability [3] - The majority of cases (70-80%) are post-surgical, with other causes being autoimmune and idiopathic [3]
Biotech Stocks Facing FDA Decision In November 2025
RTTNews· 2025-11-01 02:06
Regulatory Overview - The FDA has approved 34 novel drugs from January to October 2025, compared to 38 during the same period in 2024 [2] - Several biotech stocks are highlighted as they approach key regulatory decisions in November 2025 [2] Arrowhead Pharmaceuticals Inc. (ARWR) - ARWR's New Drug Application for Plozasiran is under FDA review, with a decision expected on November 18, 2025 [3] - Plozasiran targets familial chylomicronemia syndrome, a condition characterized by extremely high triglyceride levels, which can lead to acute pancreatitis [3] - Clinical trials showed significant reductions in triglycerides and the incidence of acute pancreatitis, potentially providing a new treatment option alongside Tryngolza, the only FDA-approved drug for this condition [4] Otsuka Holdings Co. Ltd. (OTSKF) - OTSKF is awaiting the FDA's decision on Sibeprenlimab, scheduled for November 28, 2025 [6] - Sibeprenlimab is an investigational monoclonal antibody for treating immunoglobulin A nephropathy (IgAN), a chronic kidney disease [6] - Clinical trials demonstrated a significant reduction in urine protein-to-creatinine ratio, indicating its potential as a blockbuster drug if approved [8] Bayer (BAYRY) - Bayer's investigational compound Sevabertinib is under priority review by the FDA, with a decision expected on November 28, 2025 [9] - Sevabertinib is proposed for treating advanced non-small cell lung cancer (NSCLC) with HER2 mutations, providing an additional option for previously treated patients [10] Ascendis Pharma A/S (ASND) - The FDA decision on Navepegritide, aimed at treating children with achondroplasia, is due on November 30, 2025 [11] - Achondroplasia is a rare genetic condition affecting over 250,000 people globally, leading to serious complications [12] - Navepegritide is designed for weekly subcutaneous administration, targeting the overactive FGFR3 pathway [13] Kura Oncology Inc. (KURA) - KURA is expecting FDA approval for Ziftomenib on November 30, 2025, for treating relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutations [15] - Ziftomenib has shown significant efficacy in clinical trials, with a market opportunity estimated at $350 million to $400 million annually in the U.S. if approved [17]