Ascendis Pharma Faces FDA Setback as TransCon CNP Decision Postponed to 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 28 2025
0mins
Should l Buy ASND?
Source: Benzinga
FDA Review Extension: The FDA has extended the review period for Ascendis Pharma's New Drug Application for TransCon CNP (navepegritide) for children with achondroplasia by three months, now targeting a decision by February 28, 2026.
Positive Trial Results: Recent results from the ApproaCH Trial indicate that TransCon CNP significantly improved annualized growth velocity and health-related quality of life in children with achondroplasia compared to placebo.
Additional Data on TransCon PTH: Ascendis Pharma also reported positive outcomes from a pooled analysis of TransCon PTH in adults with hypoparathyroidism, showing sustained improvements in renal function and a high percentage of patients achieving normocalcemia.
Stock Performance: Ascendis Pharma's stock has seen a slight increase, trading at $213.03, reflecting positive investor sentiment following the recent announcements.
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Analyst Views on ASND
Wall Street analysts forecast ASND stock price to rise
13 Analyst Rating
13 Buy
0 Hold
0 Sell
Strong Buy
Current: 218.100
Low
240.00
Averages
267.50
High
325.00
Current: 218.100
Low
240.00
Averages
267.50
High
325.00
About ASND
Ascendis Pharma A/S is a Denmark-based company that manufactures pharmaceutical products. The Company produces products for the treatments of growth hormone deficiency, endocrinology, central nervous system disorders, infectious diseases, and diabetes. The Company operates globally though its subsidiaries: Ascendis Pharma GmbH (Germany), Ascendis Pharma, Inc. (Delaware, United States), Ascendis Pharma Endocrinology, Inc. (Delaware, United States), Ascendis Pharma, Ophthalmology Division A/S (Denmark), Ascendis Pharma, Endocrinology Division A/S (Denmark), Ascendis Pharma Bone Diseases A/S (Denmark), Ascendis Pharma Growth Disorders A/S (Denmark) and Ascendis Pharma Oncology Division A/S (Denmark).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Statistical Significance: In a pre-specified exploratory analysis of children under 8, infigratinib showed statistical significance against placebo with an LS mean decrease of -0.05, marking a significant breakthrough in randomized trials for achondroplasia treatment.
- Regulatory Plans: BridgeBio intends to meet with regulatory authorities in the second half of 2026 to discuss plans for submitting a New Drug Application (NDA) and Marketing Authorization Application (MAA) for infigratinib, reflecting the company's confidence in future market opportunities.
- Competitive Landscape: While BioMarin's Voxzogo is the first FDA-approved drug for achondroplasia, the positive results from BridgeBio's infigratinib clinical trials may shift the competitive dynamics and enhance the company's position in the rare disease market.
See More
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- Yorvipath Market Expansion: By the end of 2025, over 5,300 patients were treated with Yorvipath across nearly 2,400 healthcare providers, achieving a 70% insurance approval rate, which supports significant growth potential for 2026 and beyond, indicating a robust market opportunity.
- Skytrofa's Strong Performance: Skytrofa generated €206 million in revenue for 2025, capturing approximately 7% market share, with plans to expand its indications through clinical trials, further solidifying its position in the growth hormone deficiency market and driving long-term growth.
- Positive Future Outlook: Ascendis Pharma anticipates achieving an operating cash flow of around €500 million in 2026 and aims for at least €5 billion in annual product revenue by 2030, demonstrating confidence in its strategic planning and growth trajectory.
See More
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- Revenue Growth: The reported total revenue of €247.5M reflects robust performance in the market, further solidifying its position in the biopharmaceutical sector.
- Increased Acquisition Speculation: Following the earnings report, Ascendis Pharma's stock price rose amid heightened speculation regarding potential acquisitions, which could lead to more strategic partnership opportunities for the company.
- Positive Market Reaction: Investors reacted positively to Ascendis Pharma's financial performance, which is expected to drive the stock price higher in the short term, enhancing market confidence in its future growth prospects.
See More
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- 2025 Financial Performance: Ascendis Pharma reported product revenue of €240 million in Q4 2025 and €684 million for the full year, driven by continued growth of YORVIPATH, with an expected operating cash flow of €500 million in 2026, indicating strong market demand and profitability.
- R&D and Market Expansion: R&D expenses for 2025 were €304 million, slightly down from 2024, primarily due to completed clinical trials, while selling, general, and administrative expenses surged to €458 million, reflecting ongoing investments in global market expansion.
- Pipeline Progress: The FDA has initiated priority review for TransCon CNP, with a key decision expected on February 28, 2026, while TransCon PTH is commercially available in over 30 countries, further solidifying Ascendis' position in the global market.
- Future Outlook and Strategic Goals: Ascendis Pharma aims to achieve at least €5 billion in global annual product revenue by 2030, showcasing its ambition in the biopharma sector and driving long-term growth through continuous innovation and market expansion.
See More
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- Revenue Growth Expectations: Despite the negative EPS outlook, the consensus revenue estimate stands at $290.25 million, representing a 66.9% year-over-year increase, suggesting potential sales growth that may attract investor interest.
- Historical Performance Review: Over the past year, Ascendis has only beaten EPS estimates 25% of the time while exceeding revenue estimates 75% of the time, indicating relative stability in revenue but a need for improvement in profitability.
- Estimate Revision Dynamics: In the last three months, EPS estimates have seen 3 upward revisions and 7 downward revisions, while revenue estimates experienced 3 upward and 6 downward revisions, reflecting market divergence and uncertainty regarding the company's future performance.
See More
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- Food Labeling Reform: On January 21, 2026, the U.S. regulator issued a Request for Information aimed at improving gluten ingredient disclosure in foods, particularly focusing on allergic reactions to rye and barley, which could drive significant changes in food industry labeling transparency.
- Future Review Outlook: As February 2026 approaches, several drugs are set for FDA review, with the industry eagerly anticipating the regulatory outcomes, as successful approvals could present substantial market opportunities for related biotech firms.
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