Ascendis Pharma

ASND

Market cap $13B

The U.S. Food & Drug Administration (FDA) on Tuesday extended review for Ascendis Pharma A/S‘ (NASDAQ: ASND) New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia.

The U.S. Food and Drug Administration on Tuesday extended its review of Ascendis Pharma's therapy for children with a rare genetic disorder that causes dwarfism, the company said.

–  Prescription Drug User Fee Act (PDUFA) goal date extended by three months to February 28, 2026 COPENHAGEN, Denmark, Nov. 25, 2025 (GLOBE NEWSWIRE) -- 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) for children with achondroplasia, constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months to February 28, 2026.

COPENHAGEN, Denmark, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that pivotal Week 52 results from its randomized double-blind, placebo-controlled ApproaCH Trial of investigational once-weekly TransCon® CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association. In the publication, titled “Once-Weekly Navepegritide in Children with Achondroplasia: The ApproaCH Randomized Clinical Trial,” the authors report that treatment with TransCon CNP led to significantly higher annualized growth velocity (AGV) at Week 52 compared to placebo (primary endpoint), as well as improved lower-limb alignment and body proportionality and positive changes in health-related quality of life, with a safety and tolerability profile similar to placebo. The abstract can be accessed on the JAMA Pediatrics website.

Ascendis Pharma A/S (ASND) Q3 2025 Earnings Call November 12, 2025 4:30 PM EST Company Participants Chad Fugere Jan Mikkelsen - President, CEO, Member of Executive Board & Executive Director Scott Smith - CFO, Executive VP & Member of Executive Board Jay Wu - Executive VP & President of Ascendis US Aimee Shu - Executive VP & Chief Medical Officer Conference Call Participants Jessica Fye - JPMorgan Chase & Co, Research Division Tazeen Ahmad - BofA Securities, Research Division Gavin Clark-Gartner - Evercore ISI Institutional Equities, Research Division Joseph Schwartz - Leerink Partners LLC, Research Division Li Wang Watsek - Cantor Fitzgerald & Co., Research Division Yaron Werber - TD Cowen, Research Division Martin Auster - Raymond James & Associates, Inc., Research Division Kyuwon Choi - Goldman Sachs Group, Inc., Research Division Yun Zhong - Wedbush Securities Inc., Research Division Charles Ndiaye - Stifel, Nicolaus & Company, Incorporated, Research Division Luca Issi - RBC Capital Markets, Research Division Maxwell Skor - Morgan Stanley, Research Division Yuxi Dong - Jefferies LLC, Research Division Presentation Operator Good day, and welcome to the Third Quarter 2025 Ascendis Pharma Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Chad Fugere, Vice President of Investor Relations at Ascendis Pharma.

–   Q3 2025 revenue of €143.1 million for YORVIPATH ® and €50.7 million for SKYTROFA ®

Ascendis Pharma A/S (NASDAQ:ASND) will release earnings results for the third quarter, after the closing bell on Wednesday, Nov. 12.

Alto Neuroscience, Autolus Therapeutics, Ascendis Pharma and Immuneering are gearing up to report Q3 results that could top expectations.

COPENHAGEN, Denmark, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that a new pooled analysis showed sustained and clinically meaningful improvements in renal function in adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide) through Year 3 of the Company's Phase 2 PaTH Forward and Phase 3 PaTHway trials. The data, which confirm results for each individual trial presented at major endocrinology meetings earlier this year, were shared during Kidney Week 2025 in a poster presented by lead author Dr. Elvira Gosmanova, a nephrologist at Albany Medical College and Albany VAMC (New York).

COPENHAGEN, Denmark, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it plans to report third quarter 2025 financial results and provide a business update on Wednesday, November 12, 2025, after the close of the U.S. financial markets. Ascendis Pharma also plans to host a conference call and live webcast on November 12, 2025, at 4:30 p.m.