Core Insights - Ascendis Pharma has received FDA approval for YORVIPATH, the first and only treatment for hypoparathyroidism in adults, highlighting the company's commitment to addressing unmet medical needs [2][4] - The company reported a second quarter revenue of €36 million, a decrease from €47.4 million in the same period last year, primarily due to negative adjustments in sales deductions [9][10] - SKYTROFA revenue for Q2 2024 was €26 million, reflecting a 27% year-over-year decrease, although there was a 134% increase in volume [3][9] - The company anticipates full-year 2024 SKYTROFA revenue to be between €220 million and €240 million [8] Financial Performance - Total revenue for Q2 2024 was €36 million, down from €47.4 million in Q2 2023, impacted by a negative adjustment of €27.1 million in sales deductions [9][10] - YORVIPATH generated €5.2 million in revenue during its first full quarter of commercial launch in Germany and Austria [4] - Research and development costs for Q2 2024 were €83.5 million, a decrease from €105 million in Q2 2023, attributed to lower external development costs [11][12] - The net loss for Q2 2024 was €109.4 million, or €1.91 per share, compared to a net loss of €121.4 million, or €2.16 per share, in Q2 2023 [12][19] Product Development and Pipeline - The company is preparing for the U.S. launch of YORVIPATH and expects initial supply to be available in Q1 2025, with potential earlier introduction in Q4 2024 [4][8] - Topline results from the pivotal ApproaCH Trial for TransCon CNP are expected in the coming weeks, with plans to submit a New Drug Application to the FDA for children with achondroplasia in Q1 2025 [5][6] - Ascendis Pharma is on track to submit a supplemental Biologics License Application for adult growth hormone deficiency for SKYTROFA in Q3 2024 [3][8] Market Position and Strategy - Ascendis Pharma's focus on rare endocrine diseases is underscored by the approval of two out of three of its TransCon product candidates, positioning the company for potential blockbuster status in the U.S. market [2][4] - The company has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma related to YORVIPATH sales in the U.S. [8]

COPENHAGEN, Denmark, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report second quarter 2024 financial results and provide a business update on Tuesday, September 3, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on September 3, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2024 financial results. Those who would like to participate may access the live webcast here, or ...

Shares of Ascendis Pharma A/S (ASND) were up 8.7% on Aug 13 after the company announced that the FDA had approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism.Yorvipath (developed as TransCon PTH) is a hormone replacement therapy for treating adults with hypoparathyroidism, a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone causes deficiencies of calcium and phosphorus compounds in the blood, r ...

Company Overview - Ascendis Pharma A/S (ASND) shares increased by 8.7% to close at $139.66, following a notable trading volume that exceeded typical levels [1] - The stock had previously experienced a 6.3% decline over the past four weeks [1] Recent Developments - The FDA approved Ascendis Pharma's hormone replacement therapy, Yorvipath (palopegteriparatide; developed as TransCon PTH), for treating adults with hypoparathyroidism, which likely contributed to the recent share price rally [1] - The company is projected to report a quarterly loss of $1.51 per share, reflecting a year-over-year increase of 35.7% [1] - Expected revenues for the upcoming quarter are $95.8 million, representing an 85.7% increase compared to the same quarter last year [1] Earnings Estimates and Market Sentiment - The consensus EPS estimate for Ascendis Pharma has remained unchanged over the last 30 days, indicating a lack of upward revisions in earnings estimates [2] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [2] - Trends in earnings estimate revisions are strongly correlated with near-term stock price movements, indicating the importance of monitoring future revisions [2] Industry Context - Ascendis Pharma operates within the Zacks Medical - Biomedical and Genetics industry [2] - Another company in the same industry, CollPlant Biotechnologies Ltd. Sponsored ADR (CLGN), saw a 0.2% decline in its stock price, closing at $4.44, with a return of -12.1% over the past month [2] - CollPlant Biotechnologies' consensus EPS estimate for the upcoming report has remained unchanged at -$0.35, which represents a significant year-over-year decline of 171.4% [3] - CollPlant Biotechnologies also holds a Zacks Rank of 3 (Hold) [3]

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 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 ...

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 ...

-  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, ...

-  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, ...

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 ...