Core Viewpoint - Ascendis Pharma A/S announced that the FDA has extended the PDUFA target action date for TransCon CNP by three months to February 28, 2026, due to a major amendment related to post-marketing requirements [1]. Group 1: FDA Interaction - The company has responded to all outstanding FDA requests, including a revised protocol for the post-marketing study, and is committed to working diligently with the FDA to finalize these elements [2]. - The extension of the PDUFA date indicates ongoing regulatory review and the need for additional information from the company [1]. Group 2: Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on innovative therapies using its 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].

Core Insights - Ascendis Pharma announced pivotal Week 52 results from the ApproaCH Trial of TransCon® CNP (navepegritide) in children with achondroplasia, showing significant improvements in annualized growth velocity compared to placebo [1][4][5] - The trial demonstrated favorable impacts on body proportionality and health-related quality of life, with a safety profile similar to placebo [1][5][6] Group 1: Trial Results - The ApproaCH Trial was a randomized, double-blind, placebo-controlled study involving 84 children aged 2-11, with a 2:1 randomization to receive either TransCon CNP at 100 μg/kg/week or placebo over 52 weeks [3] - Treatment with TransCon CNP resulted in a significant increase in annualized growth velocity (AGV) and improvements in lower-limb alignment and body proportionality compared to placebo [1][4] - The trial also reported improvements in health-related quality of life across several domains, without accelerating bone age or negatively affecting spinal curvature [5] Group 2: Treatment Profile - TransCon CNP is an investigational prodrug designed for continuous inhibition of the overactive FGFR3 pathway in achondroplasia, administered once weekly [2][6] - The treatment showed a low rate of injection site reactions and no observed symptomatic hypotension or bone fractures during the trial [5] - The FDA has placed TransCon CNP under Priority Review, with a target date of November 30, 2025, and it is also under review by the European Medicines Agency [6] Group 3: Condition Overview - Achondroplasia is a rare genetic condition affecting over 250,000 individuals globally, leading to various medical complications beyond skeletal dysplasia [7][8] - Complications include spinal abnormalities, impaired muscle strength, and chronic pain, which can significantly impact quality of life and require multiple surgeries [8]

Financial Data and Key Metrics Changes - In Q3 2025, Ascendis Pharma achieved total revenue of €214,000,000, up from €103,000,000 in Q2 2025, with a strong contribution from Europad and Skytropha [25][26] - Operating profit for Q3 2025 was €11,000,000, indicating a positive operating income development [25][26] - Cash and cash equivalents increased to €539,000,000 from €494,000,000 at the end of Q2 2025 [28] Business Line Data and Key Metrics Changes - Europad generated revenue of €143,000,000 in Q3 2025, showing strong growth in patient prescriptions and prescribers [9][25] - Skytropha contributed €50,700,000 in revenue, with a 3% growth in demand despite a foreign currency headwind [25][26] - Collaboration revenue included €20,000,000 driven by a milestone related to Europad [26] Market Data and Key Metrics Changes - In the U.S., over 4,250 patients have been prescribed Europad by more than 2,000 unique healthcare providers, indicating strong demand [10][12] - The overall insurance approval rate for Europad is around 70%, with most approvals occurring within eight weeks [12][28] - Europad is now commercially available in over 30 countries, with full reimbursement in Germany, Austria, and Spain [15] Company Strategy and Development Direction - The company aims to achieve €5,000,000,000 or more in annual product revenue by 2030, focusing on expanding its commercial organization and product offerings [23] - Ascendis Pharma is advancing its TransCon technology platform to ensure a continuous flow of new programs and products [23] - The company is also pursuing partnerships to enhance its market presence, particularly in Japan and China [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability of prescription rates and patient retention, indicating a strong foundation for future growth [33] - The company anticipates continued revenue growth driven by new patient enrollments and stable pricing in Q4 2025 [28] - Management noted that the competitive landscape does not pose significant threats to Europad's market position due to its unique properties [72] Other Important Information - TransCon CNP is under priority review by the FDA, with a PDUFA date of November 30, 2025, and is expected to become a leading treatment for children with achondroplasia [19][20] - The company is conducting a clinical trial for higher doses of TransCon PTH, which is expected to enhance treatment options for patients [100] Q&A Session Summary Question: Expectations for new patient enrollments on YorbaPath in the U.S. - Management indicated stable prescription rates and positive trends in new patient enrollments, with a strong foundation for continued growth [32][33] Question: Impact of seasonality on Q4 performance - Management does not expect significant seasonality impacts in Q4, citing a stable prescription environment [40] Question: Conversion rate for YorbaPath and future expectations - Management expects the conversion rate to improve over time, with a current approval rate of 70% [44][48] Question: Progress in different segments of the hypoparathyroidism market - Management noted strong traction among highly symptomatic patients, while emphasizing the need for patient education in less aware segments [61][63] Question: Commercial strategy for TransCon CNP - Management anticipates a significant portion of revenue will come from switching patients from existing therapies, particularly in markets with high treatment penetration [96][97]

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 ...

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 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 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 ...

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]

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]

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]