Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia – 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 ch...
Back to Near-Term Bullish on SPX and QQQ We downgraded our near-term outlook on the S&P 500 (SPX) and Nasdaq 100 (QQQ) to neutral last week (11/19/25 Compass), after being bullish since our 4/22/25 Compass, while maintaining our intermediate-term bullish outlook (as of our 5/14/25 Compass). Crucial support levels of 6480-6520 on SPX and $580-$583 on QQQ held last week, and we are right back to being near-term bullish as long as these support levels continue to hold. Just know that SPX could see...
Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics 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 Achondroplasi...
Ascendis Pharma Reports Third Quarter 2025 Financial Results – Q3 2025 revenue of €143.1 million for YORVIPATH® and €50.7 million for SKYTROFA® – Q3 2025 operating profit of €11.0 million – TransCon® CNP (navepegritide) under FDA Priority Review for the treatment of children with achondroplasia with PDUFA date of November 30, 2025 – Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the third quarter ended September 30, 2025, and provided a business update. “With ...
New Pooled 3-Year Analysis Confirms Sustained, Clinically Meaningful Improvements in Renal Function for TransCon® PTH (Palopegteriparatide)-Treated Adults with Hypoparathyroidism 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 indiv...
Ascendis Pharma to Report Third Quarter 2025 Financial Results and Provide Business Update on November 12, 2025 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. Eastern Time (ET) to discuss its third quarter 2025 financial results. Those who would like to participat...
3-Year Renal Data in Adults with Hypoparathyroidism Treated with TransCon® PTH (Palopegteriparatide) to Be Shared at Kidney Week 2025 COPENHAGEN, Denmark, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that its data showing sustained improvements in renal function, continued normalization of urine calcium handling, and continued safety and efficacy in adults with hypoparathyroidism treated with TransCon PTH (palopegteriparatide) through Year 3 of the Phase 2 PaTH Forward and Phase 3 PaTHway trials will be shared during Kidney Week 2025, the annual mee...
Downgrading Financials to Underweight We remain bullish since our 4/22/25 Compass, and we will maintain our bullish outlook as long as market dynamics remain healthy and the S&P 500 (SPX) is above 6028-6059. We would need to see a break below 6569 in order to have confidence that a consolidation period has finally begun. For now, we continue to expect support to show up at the 4-month uptrend, which generally coincides with the 20-day MA. Short-term supports to buy include 6640 (the 20-day MA),...
Ascendis Submits Marketing Authorisation Application to the European Medicines Agency for TransCon® CNP for Treatment of Children with Achondroplasia COPENHAGEN, Denmark, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TransCon CNP (navepegritide) as a treatment for children with achondroplasia, a rare genetic condition that causes skeletal dysplasia and, for many affected individuals, significant health, physical functioning, and quality of life imp...
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