- 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 ...

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 ...

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 ...

Ascendis Pharma A/S (ASND) Q1 2024 Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Tim Lee - Senior Director, Investor Relations Jan Mikkelsen - President & Chief Executive Officer Scott Smith - Executive Vice President & Chief Financial Officer Stina Singel - Executive Vice President, Clinical Development, Oncology Joe Kelly - US General Manager Conference Call Participants Jessica Fye - JPMorgan David Lebowitz - Citi Li Watsek - Cantor Joseph Schwartz - Leerink Partners Gavin Clark-Ga ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO SECTION 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of May, 2024 Commission File Number: 001-36815 Ascendis Pharma A/S (Exact Name of Registrant as Specified in Its Charter) Tuborg Boulevard 12 DK-2900 Hellerup Denmark (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Fo ...

COPENHAGEN, Denmark, April 25, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report first quarter 2024 financial results and provide a business update on Thursday, May 2, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on May 2, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2024 financial results. Those who would like to participate may access the live webcast here, or register in ...

COPENHAGEN, Denmark, April 25, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report first quarter 2024 financial results and provide a business update on Thursday, May 2, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on May 2, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2024 financial results. Those who would like to participate may access the live webcast here, or register in ...

COPENHAGEN, Denmark, April 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH® (palopegteriparatide; developed as TransCon™ PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has also granted YORVIPATH orphan drug status. YORVIPATH is a prodrug of parath ...

Things are looking better for the biotech industry in 2024 after a decent performance in 2023. The world is cautiously wading through an uncertain macroeconomic environment. This year is likely to bring more cheer for the industry as the Fed has given clear indication of multiple interest rate cuts.The majority of the biotech players do not generate enough revenues to fund their operations and are dependent on external funds. A company starts generating revenues following a successful FDA approval and the l ...

COPENHAGEN, Denmark, March 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that company executives will participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024 at 2:00 p.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 conclus ...