Ascendis Pharma (ASND) Is Up 6.9% After EMA Filing for TransCon CNP in Achondroplasia Treatment

• On October 8, 2025, Ascendis Pharma A/S announced it had submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP (navepegritide) as a potential treatment for children with achondroplasia, a rare genetic disorder impacting skeletal development and quality of life.
• This regulatory submission, supported by positive trial results and paralleling ongoing review in the US, marks a significant step in expanding the company’s rare disease portfolio internationally.
• We'll examine how the European regulatory filing for TransCon CNP could influence Ascendis Pharma's growth strategy and market outlook.

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Ascendis Pharma Investment Narrative Recap

To be a shareholder in Ascendis Pharma, you need to believe in the company's ability to achieve and maintain regulatory progress in its rare disease pipeline, particularly with TransCon CNP for achondroplasia. The submission to the European Medicines Agency is important, but the most immediate catalyst remains the US FDA review of TransCon CNP; any regulatory delays, competitive pressure, or reimbursement setbacks could still be the biggest near-term risks to growth expectations.

The July 28, 2025, FDA approval of SKYTROFA for adult growth hormone deficiency stands out here, highlighting Ascendis’s focus on extending successful platforms into new indications. This approval supports the case for regulatory-driven expansion, with multiple pipeline readouts and filings, including the achondroplasia program, as current focal points for both potential upside and risk.

In contrast, it’s crucial for investors to be aware of the challenges posed by increased global drug pricing pressures and...

Read the full narrative on Ascendis Pharma (it's free!)

Ascendis Pharma's narrative projects €2.2 billion in revenue and €826.6 million in earnings by 2028. This requires 63.9% yearly revenue growth and a €1,097.8 million increase in earnings from a current level of €-271.2 million.

Uncover how Ascendis Pharma's forecasts yield a $245.61 fair value, a 14% upside to its current price.

Exploring Other Perspectives

Fair value estimates from the Simply Wall St Community span from €193.36 to €864.52, based on four individual analyses. With so much diversity in expectations, you should consider how regulatory outcomes and payer dynamics could further influence Ascendis Pharma’s future performance.

Explore 4 other fair value estimates on Ascendis Pharma - why the stock might be worth 10% less than the current price!

Build Your Own Ascendis Pharma Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Ascendis Pharma research is our analysis highlighting 2 key rewards and 1 important warning sign that could impact your investment decision.
• Our free Ascendis Pharma research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Ascendis Pharma's overall financial health at a glance.

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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.

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