TransCon IL-2 β/γ - (IL-βelieγe)

February 11, 2026: Ascendis Pharma A/S (NASDAQ: ASND) reported Q4 and FY2025 financial results and provided a pipeline/business update. Q4 2025 product revenue was €240 million (FY2025: €684 million), with Q4 operating profit of €10 million and operating cash flow of €73 million; cash was €616 million as of Dec. 31, 2025.

TransCon CNP (navepegritide; pediatric achondroplasia): NDA is under FDA Priority Review with a PDUFA action goal date of February 28, 2026. EMA MAA was submitted in October 2025; an EMA decision is anticipated in Q4 2026. The infant label-expansion trial reACHin is ongoing with enrollment completion anticipated later in 2026.

TransCon CNP + TransCon hGH (navepegritide + lonapegsomatropin; COACH Phase 2): Week 52 topline results (announced Jan. 8, 2026) showed improved annualized growth velocity (exceeding the 97th percentile), improved body proportionality/arm span, and safety consistent with monotherapies. Week 78 data are anticipated in Q2 2026; FDA end-of-Phase 2 and EU scientific advice meetings were held in Q4 2025 ahead of a planned Phase 3 trial.

TransCon IL-2 β/γ (onvapegleukin alfa; IL-Believe): median overall survival data for a 70-patient PROC cohort are expected in Q2 2026.