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 ...

– YORVIPATH launching in U.S. with product availability expected mid-January 2025; ex-U.S. YORVIPATH revenue of €8.5 million in Q3 – TransCon CNP NDA submission for achondroplasia planned for Q1 2025 followed by MAA submission planned for Q3 2025 – SKYTROFA Q3 revenue of €47.2 million – 60%+ year-over-year volume growth offset by current and prior period sales deductions – Full year 2024 SKYTROFA revenue excluding sales deductions related to prior years expected to be €200 - €220 million, and full year 2024 ...

COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone deficiency (GHD). “The sBLA submission for TransCon hGH for adult GHD supports our strategy to develop SKYTROFA into a blockb ...

COPENHAGEN, Denmark, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the pricing of its underwritten public offering of 2,000,000 American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis, at a price to the public of $150.00 per ADS. All of the ADSs are being offered by Ascendis. The offering is expected to close on or about September 23, 2024, subject to the satisfaction of customary closing conditions. In addition, Ascendis has grant ...

COPENHAGEN, Denmark, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has commenced an underwritten public offering of $300,000,000 of American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis. All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of ADSs at the public offering price, less the underwriting commissions. Th ...

Shares of Ascendis Pharma (ASND) rose 17% on Monday after it reported top-line results from the pivotal ApproaCH study that evaluated investigational once-weekly administered TransCon CNP in children aged two to 11 years with achondroplasia, the most common form of dwarfism.ASND Drug Shows AGV Benefit in Achondroplasia PatientsThe ApproaCH study met its primary endpoint of annualized growth velocity (AGV) at 52 weeks — children treated with TransCon CNP achieved a mean AGV of 5.89 cm/year compared with 4.41 ...