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Ascendis Pharma Faces FDA Delay for TransCon CNP Approval

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Ascendis Pharma Faces FDA Delay for TransCon CNP Approval

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The latest announcement is out from Ascendis Pharma ( (ASND) ).

On November 25, 2025, Ascendis Pharma announced that the FDA has extended the PDUFA target action date for the New Drug Application of TransCon CNP for children with achondroplasia by three months to February 28, 2026. This extension follows the submission of additional information by Ascendis on November 5, 2025, which the FDA deemed a major amendment. The delay may impact Ascendis’ timeline for bringing this treatment to market, potentially affecting its competitive positioning in the biopharmaceutical industry.

The most recent analyst rating on (ASND) stock is a Buy with a $242.00 price target. To see the full list of analyst forecasts on Ascendis Pharma stock, see the ASND Stock Forecast page.

Spark’s Take on ASND Stock

According to Spark, TipRanks’ AI Analyst, ASND is a Neutral.

Ascendis Pharma’s overall stock score is primarily influenced by its financial performance challenges, including high leverage and negative cash flows. While the earnings call provided positive insights into revenue growth and regulatory progress, the stock’s valuation remains unattractive due to ongoing losses. Technical indicators suggest a lack of strong momentum, further impacting the score.

To see Spark’s full report on ASND stock, click here.

More about Ascendis Pharma

Ascendis Pharma A/S is a biopharmaceutical company based in Denmark, primarily focused on developing innovative therapies for rare endocrine diseases. The company utilizes its proprietary TransCon technology to create long-acting prodrugs, aiming to improve treatment options for patients with unmet medical needs.

Average Trading Volume: 466,365

Technical Sentiment Signal: Buy

Current Market Cap: $12.77B

For a thorough assessment of ASND stock, go to TipRanks’ Stock Analysis page.

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