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- Annualized height velocity of 9.05 cm/year (LS mean) for TransCon hGH-treated children was similar at Week 52 to daily somatropin-treated children - TransCon hGH showed a safety and tolerability profile comparable to daily somatropin with no occurrences of slipped capital femoral epiphysis (SCFE) COPENHAGEN, Denmark, March 17, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive Week 52 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. investigating the safety, tolerability, and efficacy of once-weekly TransCon hGH (lonapegsomatropin; U.S. FDA-approved for pediatric and adult growth hormone deficiency (GHD) and approved in other territories for pediatric GHD) compared to daily somatropin in prepubertal children with Turner syndrome. New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old.
COPENHAGEN, Denmark, March 16, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from its pivotal ApproaCH Trial showing that children with achondroplasia treated with once-weekly TransCon CNP (navepegritide) maintained consistent improvements in growth through Week 104, with further improvement in body proportionality during the second year of treatment. These and other results were shared in an oral presentation by Dr. Ravi Savarirayan, M.B.B.S.
COPENHAGEN, Denmark, March 02, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in a virtual fireside chat at the TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026, at 11:10 a.m. Eastern Time / 8:10 a.m. Pacific Time in Boston, Massachusetts.
COPENHAGEN, Denmark, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA's Accelerated Approval Program for YUVIWEL® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
