COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide)...
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COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria. YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune, genetic, or idiopathic), including improvements...
For the TransCon CNP treatment-naïve cohort, combination treatment resulted in mean annualized growth velocity (AGV) of 9.14 cm/year, with an improvement in mean ACH height Z-score of +0.53 over 26 weeks For the TransCon CNP-treated cohort, combination treatment resulted in mean AGV of 8.25 cm/year, with an improvement in mean...
COPENHAGEN, Denmark — 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...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today provided updates across its achondroplasia programs. “The rapid uptake of YUVIWEL in the United States underscores its highly differentiated profile and reflects our core values and our patient-centered development of therapies,” said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. “We are very...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from a subgroup analysis showing that children with achondroplasia ≥5 years of age at enrollment treated with once-weekly TransCon CNP (navepegritide) in its pivotal ApproaCH Trial demonstrated significantly greater annualized growth velocity (AGV) compared to placebo at Week...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced three oral presentations of its latest achondroplasia and hypoparathyroidism data at ASBMR 2025, the annual meeting of the American Society for Bone & Mineral Research being held in Seattle from September 5-8, 2025. These include a new analysis of pivotal...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced that its participation at ISDS 2026, the annual meeting of the International Skeletal Dysplasia Society being held in Toronto, Canada, from August 26-29, 2026, will include an oral presentation of Week 104 data from its pivotal ApproaCH Trial of once-weekly...
COPENHAGEN, Denmark — Ascendis Pharma A/S (Nasdaq: ASND) today announced new data demonstrating TransCon hGH accelerated TransCon CNP’s benefits beyond linear growth with substantial improvements in arm span, spinal canal dimensions, and lower limb alignment. The new data are from Week 52 of the ongoing Phase 2 COACH Trial of...