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Weaker USD, Revenue Growth, And TransCon Technology Make Ascendis Pharma A Strong Buy Opportunity
Seeking Alpha· 2024-07-29 09:52
da-kuk Ascendis Pharma A/S (ASND), based in Copenhagen, Denmark, is a biopharmaceutical company that utilizes its proprietary TransCon technology platform to develop advanced therapeutics for endocrinology, rare diseases, and oncology. This TransCon system aims to deliver best-in-class therapies with controlled drug release, optimized effects, and less toxicity. The company’s FDA-approved product, Skytrofa, is indicated for pediatric growth hormone deficiency [GHD] and is proof of the efficacy of TransC ...
Data from Phase 2 ACcomplisH Trial of TransCon CNP in Children with Achondroplasia Presented at ICCHBH 2024
Newsfilter· 2024-06-24 20:45
• Data demonstrate significant improvements in well-being and physical functioning compared to placebo in patients treated for 1 year with TransCon CNP at the pivotal 100μg/kg/week dose • Improvements could not be explained by changes in linear growth only, supporting a potential additional direct treatment effect of TransCon CNP beyond linear growth COPENHAGEN, Denmark, June 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced the oral presentation of data from its Phase 2 ACcomp ...
Ascendis Pharma to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference
Newsfilter· 2024-06-04 20:01
COPENHAGEN, Denmark, June 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that company executives will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 8:00 a.m. ET in Miami, Florida. A live webcast of the fireside chat will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after co ...
Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024
Newsfilter· 2024-06-03 20:01
-  40% of efficacy-evaluable patients (2 out of 5) in the initial cohort of patients with anti-PD-1 refractory melanoma treated with TransCon IL-2 β/γ in combination with TransCon TLR7/8 Agonist exhibited confirmed clinical responses with no new safety signals -  45% of efficacy-evaluable patients (5 out of 11) whose disease progressed on check-point inhibitors exhibited confirmed clinical responses when treated with TransCon IL-2 β/γ as monotherapy or in combination treatment COPENHAGEN, Denmark, June 03, ...
Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024
GlobeNewswire News Room· 2024-06-03 20:01
-  40% of efficacy-evaluable patients (2 out of 5) in the initial cohort of patients with anti-PD-1 refractory melanoma treated with TransCon IL-2 β/γ in combination with TransCon TLR7/8 Agonist exhibited confirmed clinical responses with no new safety signals -  45% of efficacy-evaluable patients (5 out of 11) whose disease progressed on check-point inhibitors exhibited confirmed clinical responses when treated with TransCon IL-2 β/γ as monotherapy or in combination treatment COPENHAGEN, Denmark, June 03, ...
Ascendis to Spotlight Latest Updates for TransCon™ Rare Endocrinology Disease Portfolio at ENDO 2024
Newsfilter· 2024-05-30 12:30
COPENHAGEN, Denmark, May 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that it will host informational booths, events, and presentations showcasing use of its innovative TransCon technology in the areas of growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome during ENDO 2024, the annual meeting of the Endocrine Society being held June 1-4, 2024, in Boston. "In addition to physician and caregiver presentations in pediatric GHD, we look forw ...
FDA Delays Decision on Ascendis' (ASND) Hormone Therapy Filing
Zacks Investment Research· 2024-05-15 15:46
Shares of Ascendis Pharma (ASND) lost more than 5% on Tuesday after management announced that the FDA extended the review period for its regulatory filing for a hormone replacement therapy by an additional three months. A final decision is now expected by Aug 14, 2024.The company’s filing seeks approval for TransCon PTH (palopegteriparatide) to treat adults with hypoparathyroidism, a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone ...
Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism
Newsfilter· 2024-05-14 18:31
- Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024 COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA's ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to th ...
Significant and Sustained Improvements in Renal Function Reported for Adults with Chronic Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide): 2-year Results from Phase 3 PaTHway Trial
Newsfilter· 2024-05-13 12:30
COPENHAGEN, Denmark, May 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced 2-year results from a post-hoc analysis of the Company's Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide). The data were shared in an oral presentation on May 12 by Peter Schwarz, M.D., Professor of Clinical Medicine at the University of Copenhagen, during the European Cong ...
Latest Clinical and Quality-of-Life Data for TransCon™ PTH (Palopegteriparatide)-Treated Adults with Chronic Hypoparathyroidism to Be Presented at ECE 2024
Newsfilter· 2024-05-09 12:30
COPENHAGEN, Denmark, May 09, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that new TransCon PTH (palopegteriparatide) data supporting clinical and quality-of-life benefits in adult patients with chronic hypoparathyroidism will be presented at the European Congress of Endocrinology being held May 11-14, 2024, in Stockholm. Topics include an oral presentation of new 2-year results from a post-hoc analysis of the Phase 3 PaTHway Trial demonstrating sustained improvements in kidney ...