– Strong early U.S. YORVIPATH® launch with 908 prescriptions as of Feb. 7, 2025; YORVIPATH full year 2024 revenue of €28.7 million – Following pre-NDA meeting with FDA, on track to submit TransCon™ CNP NDA for achondroplasia in children in Q1 2025, followed by MAA in Q3 2025 – SKYTROFA® full year 2024 revenue was ~€202 million, excluding sales deductions related to prior years, (€197.0 million plus ~€5 million of sales deductions related to prior years) – Total 2024 operating expenses of €598 million – Con ...

COPENHAGEN, Denmark, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report full year 2024 financial results and provide a business update on Wednesday, February 12, 2025, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on February 12, 2025, at 4:30 p.m. Eastern Time (ET) to discuss 2024 financial results. Those who would like to participate may access the live webcast here, or register in advance fo ...

I’m a stock analyst with an MBA and a background in healthcare, bringing years of experience as a Registered Nurse dedicated to patient care. I've had the privilege of sharing my insights on Seeking Alpha since 2017. I am most interested in identifying underlying assumptions in stock valuations by emphasizing financial modeling techniques like DCF analysis. I then provide scenario-based forecasts to help readers gauge reasonable outcomes. I am influenced by books like Superforecasting and Antifragile. As su ...

This is my first Ascendis Pharma ( ASND ) article. I became interested in this name as a consequence of researching my recent article on BioMarin ( BMRN ). As it turns out Ascendis isWriting under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experience from decades of investing and from ~5 years of focused research on a variety of stock ...

Business and Strategic Roadmap - Ascendis Pharma is positioned for rapid revenue growth driven by the launch of its first two Endocrinology Rare Disease medicines, SKYTROFA and YORVIPATH, and planned filings for its third product, TransCon CNP for achondroplasia [2] - The company's expanding TransCon technology platform and partnerships demonstrate a business model focused on fast, successful drug development, aiming to create substantial stakeholder value [2] Key Updates and Milestones TransCon hGH (SKYTROFA) - SKYTROFA full-year 2024 revenue expected to be ~€202 million, excluding sales deductions related to prior years [3][7] - U.S. SKYTROFA volume (mg) increased 84% year-over-year in 2024, capturing an estimated 6.5% market share of the total U.S. growth hormone market [3] - PDUFA goal date of July 27, 2025, for FDA review of supplemental BLA for adult growth hormone deficiency treatment, with a planned U.S. commercial launch in Q4 2025 [3] - Plan to submit an IND application or similar for a basket trial evaluating TransCon hGH in additional indications during Q3 2025 [3] TransCon PTH (YORVIPATH) - YORVIPATH full-year 2024 unaudited preliminary revenue estimate of ~€29 million [3][7] - Commercially available in Germany and Austria since January 2024, with ~700 patients on treatment in Europe Direct and International Markets by the end of 2024 [3] - Available for prescription in the U.S. since late December 2024, with 324 patients enrolled in the Ascendis Signature Access Program or direct with specialty pharmacy as of January 9, 2025 [3] - Expect commercial launch in at least five additional Europe Direct countries in 2025 [3] TransCon CNP (navepegritide) - Plan to submit NDA for the treatment of children with achondroplasia in Q1 2025 and Marketing Authorisation Application to the European Medicines Agency in Q3 2025 [3] - New data from the ApproaCH Trial showed significant improvements in leg bowing with TransCon CNP compared to placebo [3] - Topline Week 26 results from Phase 2 COACH Trial expected in Q2 2025 [3] - Plan to submit an IND or similar for the treatment of hypochondroplasia in Q4 2025 [3] Expanding the TransCon Platform & Pipeline - Development of a new TransCon protein degrader platform designed to enable efficient clearance of hormones, cytokines, and other targets [3] - First planned TransCon protein degrader product candidate aims to normalize excess FGF-23 hormone levels for patients with X-linked hypophosphatemia [3] Financial Update - Unaudited preliminary estimate of total full-year 2024 product revenue of ~€226 million [3] - Total full-year 2024 revenue, including a $100 million Novo Nordisk milestone payment, estimated at ~€364 million [7] - Pro forma cash balance as of December 31, 2024, estimated at ~€655 million, including the expected Novo Nordisk payment [7] Presentation at J.P. Morgan Healthcare Conference - Ascendis Pharma's President and CEO Jan Mikkelsen will present the business and strategic roadmap update at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025 [1][4] - A live webcast of the event will be available on the company's Investor Relations website, with a replay accessible for 30 days [4]

COPENHAGEN, Denmark, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time in San Francisco, California. A live webcast of the presentation 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 web ...

COPENHAGEN, Denmark, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide; developed as TransCon PTH) is now commercially available by prescription in the United States. YORVIPATH is a prodrug of parathyroid hormone (PTH [1-34]), administered once-daily, designed to provide continuous exposure to active PTH over the 24-hour dosing period. It is the first and only medicine approved by the U.S. Food & Drug Administration (FDA) for the treatm ...

- Results for all three TransCon hGH starting dose cohorts, in first clinical trial of an indication outside of growth hormone deficiency, showed a safety and tolerability profile comparable to daily somatropin - Annualized height velocity was similar at Week 26 in once-weekly TransCon hGH-treated and daily somatropin-treated children COPENHAGEN, Denmark, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced positive Week 26 topline results from New InsiGHTS, its Phase 2 rando ...

COPENHAGEN, Denmark, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA® for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025. “This marks another step towards achieving our objective to expand SKYTROFA ...

Ascendis Pharma A/S (ASND) Q3 2024 Earnings Conference Call November 14, 2024 4:30 PM ET Company Participants Jan Mikkelsen - President & Chief Executive Officer Scott Smith - Executive Vice President & Chief Financial Officer Camilla Harder Hartvig - Head of Global Commercial Operation Joe Kelly - US General Manager Conference Call Participants Jessica Fye - JPMorgan Tazeen Ahmad - Bank of America Yaron Werber - TD Cowen Gavin Clark-Gartner - Evercore ISI Li Watsek - Cantor Fitzgerald Joseph Schwartz - Lee ...