Ascendis Pharma Nears Critical Regulatory Verdict

Ascendis Pharma reports €720M revenue, nears FDA decision on key drug TransCon CNP. Company targets €5B annual revenue by 2030 and initiates $120M share buyback.

Investor focus is intensifying on Danish biopharmaceutical firm Ascendis Pharma A/S as it approaches a pivotal moment. The catalyst is an upcoming decision from the U.S. Food and Drug Administration (FDA) concerning a key drug candidate, scheduled for February 28. This regulatory review follows a year of substantial revenue growth for the company, setting the stage for a potentially transformative period.

Financial Performance Shows Strong Momentum

Recent financial results for the fiscal year underscore a period of rapid expansion. Ascendis Pharma reported total revenue of €720.1 million, representing a near doubling from the prior year's figure of €363.6 million. This impressive growth was primarily fueled by the commercial performance of its two flagship products, YORVIPATH and SKYTROFA, which accounted for the majority of sales.

Despite the significant top-line increase, the company posted a net loss of €228 million. However, a crucial positive signal emerged: Ascendis generated a positive operating cash flow for the first time, marking a fundamental step toward greater financial stability. Market sentiment reflected this progress, with the share price reaching a new 52-week high of €202.00.

All Eyes on the FDA's TransCon CNP Decision

The immediate spotlight is fixed on the FDA's verdict for TransCon CNP, a treatment designed for pediatric achondroplasia, a form of short-limbed dwarfism. The regulatory agency extended its review period to the end of February after the company submitted additional data. A favorable outcome would grant access to the crucial U.S. market and significantly accelerate the firm's growth trajectory.

Parallel regulatory processes are underway in Europe, where a decision from the European Medicines Agency (EMA) is anticipated in the fourth quarter of 2026.

Long-Term Ambition and Capital Allocation

Looking beyond the immediate horizon, Ascendis operates under a long-term "Vision 2030" strategy. Management has set an ambitious target of achieving annual product revenue exceeding €5 billion by the end of the decade. To demonstrate confidence in its strategic path and financial outlook, the company's board has authorized a share repurchase program valued at $120 million for the current year.

Furthermore, the company has provided a financial projection for 2026, forecasting an operating cash flow of approximately €500 million. This estimate does not yet include any potential contribution from the TransCon CNP candidate. The calendar for the coming months is set: following the FDA's announcement on February 28, shareholders will convene at the annual general meeting in Copenhagen on March 23 to review the audited financial statements and the company's strategic direction.