ASND earnings
Ascendis Pharma A/S (ASND) earnings releases and earnings dates - real-time wire coverage of every quarterly report.
Recent earnings items
- Ascendis Pharma Reports First Quarter 2026 Financial Results- Q1 2026 revenue of €197 million for YORVIPATH® and €44 million for SKYTROFA® - More than 1,000 new patient enrollments for YORVIPATH in the U.S. in Q1 - As of May 1, more than 60 YUVIWEL® enrollments since early April U.S. commercial launch - Entered into agreement to sell Rare Pediatric Disease Priority Review Voucher for $187.5 million - Conference call today at 8:00 am ET COPENHAGEN, Denmark, May 07, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the first quarter ended March 31, 2026, and provided a business update. "The FDA approval of YUVIWEL, our third consecutive TransCon product, and the robust patient uptake for YORVIPATH
- Ascendis to Report First Quarter 2026 Financial Results and Provide Business Update on May 7, 2026COPENHAGEN, Denmark, April 30, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it plans to report first quarter 2026 financial results and provide a business update on Thursday, May 7, 2026, before the open of the U.S. financial markets. Ascendis Pharma also plans to host a conference call and live webcast on May 7, 2026, at 8:00 a.m. Eastern Time (ET) to discuss its first quarter 2026 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.asce
- FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and OlderThe first and only approved achondroplasia therapy to provide continuous systemic exposure to CNP over the weekly dosing intervalCommercial availability expected during early part of Q2 2026Rare Pediatric Disease Priority Review Voucher granted in connection with approvalAscendis to host investor conference call Monday, March 2, at 8:00 am ET COPENHAGEN, Denmark, Feb. 27, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA's Accelerated Approval Program for YUVIWEL® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growt
- Ascendis Pharma Reports Fourth Quarter and Full-Year 2025 Financial ResultsQ4 2025 product revenue of €240 million and FY 2025 product revenue of €684 millionQ4 2025 operating profit of €10 million and cash flow from operating activities of €73 millionTransCon® CNP under FDA Priority Review, PDUFA action goal date of February 28, 2026Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. "With a continued focus on making a meaningful difference for patients, we believe Ascendis is entering a steep growth phase as we transform into a leading global biopharma company,"
- Ascendis Pharma to Report Full Year 2025 Financial Results and Provide Business Update on February 11, 2026COPENHAGEN, Denmark, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it plans to report full year 2025 financial results and provide a business update on Wednesday, February 11, 2026, after the close of the U.S. financial markets. Ascendis Pharma also plans to host a conference call and live webcast on February 11, 2026, at 4:30 p.m. Eastern Time (ET) to discuss 2025 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma
- Week 52 COACH Trial Topline Results Confirm Consistent and Durable Treatment Benefits in Children with Achondroplasia (ACH)– Once-weekly TransCon® CNP and TransCon® hGH combination therapy showed durable growth without compromising safety or tolerability at 52 weeks – Annualized growth velocity (AGV) exceeded the 97th-percentile of average stature children – ACH height Z-score improvements indicated a tripling of efficacy compared to TransCon CNP monotherapy – Combination therapy demonstrated benefits beyond linear growth with improvements in body proportionality and arm span, aligning with the increase in linear growth – All children completed 52 weeks of treatment and remain on therapy in COACH as of today – Combination therapy was generally well tolerated, with generally mild treatment-emergent adverse
- Ascendis Pharma Reports Third Quarter 2025 Financial Results– Q3 2025 revenue of €143.1 million for YORVIPATH® and €50.7 million for SKYTROFA® – Q3 2025 operating profit of €11.0 million – TransCon® CNP (navepegritide) under FDA Priority Review for the treatment of children with achondroplasia with PDUFA date of November 30, 2025 – Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the third quarter ended September 30, 2025, and provided a business update. "With our achievements in the third quarter and year to date, Ascendis is making great progress toward achieving Vision 2030. The ongoing strong global launch of YORVIPATH
- Ascendis Pharma to Report Third Quarter 2025 Financial Results and Provide Business Update on November 12, 2025COPENHAGEN, Denmark, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it plans to report third quarter 2025 financial results and provide a business update on Wednesday, November 12, 2025, after the close of the U.S. financial markets. Ascendis Pharma also plans to host a conference call and live webcast on November 12, 2025, at 4:30 p.m. Eastern Time (ET) to discuss its third quarter 2025 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://in
- Ascendis Pharma Reports Second Quarter 2025 Financial Results– Q2 2025 revenue of €103.0 million for YORVIPATH® and €50.7 million for SKYTROFA® – TransCon® CNP (navepegritide) NDA under Priority Review for the treatment of children with achondroplasia with PDUFA date of November 30, 2025 – SKYTROFA® (lonapegsomatropin-tcgd) approved in the U.S. for treatment of adults with growth hormone deficiency; first of many planned label expansions – Week 26 Interim Results for COACH trial highlight the unique portfolio of once-weekly TransCon CNP and once-weekly TransCon hGH, with complementary modes of action, to potentially further transform the treatment landscape for growth disorders and physical functioning –Conference call today at 4:30 pm ET COPENH
- Ascendis Pharma to Report Second Quarter 2025 Financial Results and Provide Business Update on August 7, 2025COPENHAGEN, Denmark, July 31, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report second quarter 2025 financial results and provide a business update on Thursday, August 7, 2025, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on August 7, 2025, at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2025 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascen
- TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial- For the TransCon CNP treatment-naïve cohort, combination treatment resulted in mean annualized growth velocity (AGV) of 9.14 cm/year, with an improvement in mean ACH height Z-score of +0.53 over 26 weeks - For the TransCon CNP-treated cohort, combination treatment resulted in mean AGV of 8.25 cm/year, with an improvement in mean ACH height Z-score of +0.44 over 26 weeks - The combination of TransCon hGH and TransCon CNP demonstrated accelerated improvement in body proportionality at Week 26, aligning with the increase in linear growth - Safety and tolerability data consistent with those observed for TransCon hGH and TransCon CNP monotherapies; combination treatment was generally well to
- Ascendis Pharma to Report First Quarter 2025 Financial Results and Provide Business Update on May 1, 2025COPENHAGEN, Denmark, April 24, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report first quarter 2025 financial results and provide a business update on Thursday, May 1, 2025, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on May 1, 2025, at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2025 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendisphar
- Ascendis Pharma Reports Fourth Quarter and Full Year 2024 Financial Results– 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 – Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Feb. 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the fourth quarter an
- Ascendis Pharma to Report Full Year 2024 Financial Results and Provide Business Update on February 12, 2025COPENHAGEN, 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 for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A
- Ascendis Pharma Reports Third Quarter 2024 Financial Results– 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 operating expenses of approximately €600 million – Novo Nordisk collaboration for the development of product candidates in metabolic and cardiovascular diseases, including a once-mont
- Ascendis Pharma to Report Third Quarter 2024 Financial Results and Provide Business Update on November 14, 2024COPENHAGEN, Denmark, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report third quarter 2024 financial results and provide a business update on Thursday, November 14, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on November 14, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its third quarter 2024 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.a
- Pivotal ApproaCH Trial of TransCon™ CNP (Navepegritide) Achieved Primary Objective, Demonstrated AGV Superior to Placebo– TransCon CNP demonstrated AGV superior to placebo with LS mean treatment difference of 1.49 cm/year at Week 52 (p<0.0001) – For children aged 5-11 years TransCon CNP demonstrated a change from baseline AGV superior to placebo with LS mean treatment difference of 1.78 cm/year at Week 52 (p<0.0001) – Other endpoints supportive that TransCon CNP may provide benefits beyond linear growth – TransCon CNP was generally well-tolerated, with low frequency of injection site reactions (0.41 events per patient year), all mild – Ascendis to host investor conference call Monday, September 16, at 8:00 a.m. E.T. COPENHAGEN, Denmark, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma
- Ascendis Pharma Reports Second Quarter 2024 Financial ResultsYORVIPATH approved by U.S. Food & Drug Administration (FDA) as the first and only treatment of hypoparathyroidism in adultsTransCon CNP (navepegritide) pivotal ApproaCH Trial topline results expected in the coming weeksSKYTROFA Q2 revenue of €26 million – 134% year-over-year volume growth offset by negative adjustment of €27 million, resetting market access for continued growthRevising full year 2024 SKYTROFA revenue outlook to €220 - €240 millionConference call today at 4:30 pm ET COPENHAGEN, Denmark, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the second quarter ended June 30, 2024, and provided a business update. "The rece
- Ascendis Pharma to Report Second Quarter 2024 Financial Results and Provide Business Update on September 3, 2024COPENHAGEN, 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 register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.
- FDA Approves YORVIPATH® (Palopegteriparatide) as the First and Only Treatment for Hypoparathyroidism in Adults- Hypoparathyroidism is a rare endocrine disease with multi-organ impacts affecting an estimated 70,000 to 90,000 people in the United States - Ascendis to host investor conference call Monday, August 12, at 8:00 a.m. E.T. COPENHAGEN, Denmark, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved YORVIPATH® (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. YORVIPATH is a prodrug of parathyroid hormone (PTH[1-34]), administered once daily, designed to provide continuous exposure to released PTH over the 24-hour dosing period. Hypoparathyroid
- Ascendis Pharma Reports First Quarter 2024 Financial Results— Rollout of YORVIPATH® initiated in Germany and Austria, with an estimated 55 doctors writing prescriptions and ~100 patients receiving commercial product as of March 31 — TransCon™ PTH (palopegteriparatide) PDUFA date of May 14, 2024, for adults with hypoparathyroidism. If approved, U.S. launch planned in Q3 — TransCon CNP (navepegritide) pivotal ApproaCH Trial on track for topline results in Q4 2024 — SKYTROFA® Q1 revenue more than doubled year-over-year to €65 million; Q1 operating expenses fell by 20% year-over-year to €137 million — Ascendis remains on track for achieving full-year 2024 SKYTROFA revenue of €320 to €340 million and full year 2024 operating expenses of €600 million
- Ascendis Pharma to Report First Quarter 2024 Financial Results and Provide Business Update on May 2, 2024COPENHAGEN, 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 advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendisph
- Ascendis Pharma Reports Fourth Quarter and Full Year 2023 ResultsLaunch of TransCon™ PTH underway with full commercial availability in Germany and Austria; U.S. PDUFA date of May 14, 2024TransCon CNP pivotal ApproaCH Trial on track for topline results in Q4 2024Total Q4 revenue of €138 million including SKYTROFA® revenue of €64 million; Q4 operating expenses of €155 million Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update. "In 2023, we streamlined Ascendis, including our structure, processes, and operating expense allocation, and at the same time we bel
- Ascendis Pharma to Report Full Year 2023 Financial Results and Provide Business Update on February 7, 2024COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report full year 2023 financial results and provide a business update on Wednesday, February 7, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and webcast on February 7, 2024, at 4:30 p.m. Eastern Time (ET) to discuss 2023 financial results. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay
- Ascendis Pharma Reports Third Quarter 2023 Financial ResultsEuropean Commission decision for TransCon™ PTH expected this month; if approved, first European Union launch planned in Germany in January 2024TransCon PTH NDA resubmission to FDA expected before mid-NovemberCompleted enrollment in the Phase 3 ApproaCH Trial; initiated TransCon CNP infant trial in the third quarter 2023; expect to initiate combination trial of TransCon CNP and TransCon hGH in the fourth quarter 2023 SKYTROFA Q3 revenue of €47.0 million, increasing full year 2023 SKYTROFA revenue expectations to €170 – €175 million Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results f
- Ascendis Pharma Announces Timing of Third Quarter 2023 Financial Results and TransCon PTH NDA Resubmission• Third Quarter financial results and business update conference call to be held onNovember 7, 2023 • Resubmission of TransCon PTH NDA for adults with hypoparathyroidism expected beforemid-November 2023 COPENHAGEN, Denmark, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report third quarter 2023 financial results and provide a business update on Tuesday, November 7, 2023, after the close of the U.S. financial markets. In addition, Ascendis Pharma announced that it plans to resubmit its NDA for TransCon PTH for adults with hypoparathyroidism to the FDA before mid-November 2023. Ascendis Pharma will also host a conference call and webcas
- Ascendis Pharma Reports Second Quarter 2023 Financial ResultsExpect to resubmit NDA to FDA for TransCon™ PTH in October 2023; EC decision on MAA for TransCon PTH expected during the fourth quarter of 2023U.S. and EU regulatory authorities endorsed ApproaCH as a pivotal Phase 3 trial of TransCon CNP in children with achondroplasia; enrollment completed, and topline results expected in second half of 2024Raising full year 2023 U.S. SKYTROFA®* revenue expectations to €165 - €170 millionConference call today at 4:30 pm ET COPENHAGEN, Denmark, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the second quarter ended June 30, 2023 and provided business updates. "We have built a fully integrated E
- Ascendis Pharma to Report Second Quarter 2023 Financial Results and Provide Business Update on September 5, 2023COPENHAGEN, Denmark, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced it will report second quarter 2023 financial results and provide a business update on Tuesday, September 5, 2023, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and webcast on September 5, 2023, at 4:30 p.m. Eastern Time (ET) to discuss second quarter 2023 financial results and operations. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://inve
- U.S. Food & Drug Administration Issues Complete Response Letter for TransCon™ PTH in HypoparathyroidismFDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product No new preclinical studies, or Phase 3 clinical trials to evaluate safety or efficacy, were requested in the letterAscendis will work collaboratively with the FDA to make TransCon PTH available to patients in the U.S. as quickly as possible Conference call today at 8:30 am ET COPENHAGEN, Denmark, May 01, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has issued a complete response letter (CRL) for the TransCon PTH (palopegteriparatide) New Drug Application (NDA) for
- Ascendis Pharma Reports First Quarter 2023 Financial Results• Focused on bringing TransCon™ PTH to the U.S. and EU markets as soon as possible • 145 of 154 clinical trial participants continue treatment with TransCon PTH for up to 3 years, and U.S. Expanded Access Program continues to enroll new patients • SKYTROFA®* revenue reached €31.6 million in the first quarter of 2023; Ascendis expects full-year 2023 SKYTROFA revenue of €150 - €160 million • Company to hold Oncology program update on Wednesday, May 31 in New York City • Conference call today at 4:30 pm ET COPENHAGEN, Denmark, April 27, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the first quarter ended March 31, 2023 and pro
- Ascendis Pharma Announces First Quarter 2023 Financial Results and Business Update Conference Call on April 27COPENHAGEN, Denmark, April 13, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the company will hold a conference call and live webcast on Thursday, April 27, 2023, at 4:30 p.m. Eastern Time (ET) to review its first quarter 2023 financial results and provide a business update. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our website shortly after conclusion of the even
- Ascendis Pharma Provides Update on Regulatory Reviews of TransCon PTH™ in HypoparathyroidismCOPENHAGEN, Denmark, April 03, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has notified the Company that, as part of their ongoing review, the FDA has identified deficiencies in the Company's New Drug Application (NDA) for TransCon PTH (palopegteriparatide) in hypoparathyroidism that at this time precludes them from holding further discussions about labeling and post-marketing requirements/commitments. The deficiencies were not disclosed in the letter. The FDA also stated that this does not reflect their final regulatory decision on the Company's application. "This notification from FDA relates to their revi
- Ascendis Pharma Reports Full Year 2022 ResultsTransCon™ PTH PDUFA date of April 30, 2023, for adults with hypoparathyroidism; European MAA decision expected in the fourth quarter of 2023Expanding TransCon hGH geographic reach with planned launch in Germany in the third quarter of 2023; Phase 3 data in adult GHD indication expected in the fourth quarter of 2023 Initiated Phase 2b ApproaCH Trial for TransCon CNP in achondroplasia; expected to complete enrollment in the second quarter of 2023SKYTROFA® U.S. revenue grew to €17.1 million in the fourth quarter of 2022, providing a foundation for growth in 2023 and beyondConference call today at 4:30 pm ET COPENHAGEN, Denmark, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDA
- Ascendis Pharma Announces Full Year 2022 Financial Results and Business Update Conference Call on February 16COPENHAGEN, Denmark, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the company will hold a conference call and live webcast on Thursday, February 16, 2023, at 4:30 p.m. Eastern Time (ET) to review its 2022 financial results and provide a business update. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 day
- Once-Weekly TransCon™ CNP Achieved Primary Efficacy Objective, with Superiority at 100 µg/kg/week, in Ascendis Pharma's Phase 2 ACcomplisH Trial of Children with Achondroplasia Aged 2 to 10 Years- Data demonstrated that once-weekly TransCon CNP has the potential to meet patient and caregiver needs for a safe, effective, tolerable and convenient treatment - The primary endpoint, annualized height velocity (AHV) at Week 52, demonstrated superiority of TransCon CNP at 100 µg/kg/week compared to placebo (p=0.0218) - TransCon CNP was generally well tolerated with low frequency of injection site reactions; all 57 randomized children continued, with the longest treatment duration beyond two years - Data showed robust and consistent results in prespecified analyses across age groups and dose levels, supporting continued development at the selected dose of 100 µg/kg/week - As
- Ascendis Pharma Reports Third Quarter 2022 Financial Results- SKYTROFA® U.S. revenue more than doubled quarter-to-quarter again, reaching €12.3 million in the third quarter - FDA accepted for Priority Review TransCon™ PTH NDA in adult patients with hypoparathyroidism; target action PDUFA date is April 30, 2023 - Announced selection of Phase 2 recommended dose of TransCon TLR7/8 Agonist; first-in-human data accepted for oral presentation at SITC 2022 - Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the third quarter ended September 30, 2022 and provided a business update. "With our improved commercial execution and em
- Ascendis Pharma A/S Announces Third Quarter 2022 Financial Results and Business Update Conference Call on November 2COPENHAGEN, Denmark, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) announced today that the company will hold a conference call and live webcast on Wednesday, November 2, 2022, at 4:30 p.m. Eastern Time (ET) to review its third quarter 2022 financial results and provide a business update. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our website shortly after conclusion of the ev
- Ascendis Pharma A/S Reports Second Quarter 2022 Financial Results— U.S. regulatory submission for TransCon PTH, designed to be the first parathyroid hormone replacement therapy, on track for Q3 2022; EU submission planned for Q4 2022 — SKYTROFA revenue continued to double quarter-to-quarter, reaching €4.4 million in the second quarter — With anticipated growth in U.S. revenues and approximately €1 billion of cash, cash equivalents, and marketable securities on hand, Ascendis is positioned to fulfill Vision 3x3 and become cash flow positive — Conference call today at 4:30 pm ET COPENHAGEN, Denmark, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the second quarter ended June 30, 2022, an
- Ascendis Pharma A/S Announces Second Quarter 2022 Financial Results and Business Update Conference Call on August 10COPENHAGEN, Denmark, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) announced today that the company will hold a conference call and live webcast on Wednesday, August 10, 2022, at 4:30 p.m. Eastern Time (ET) to review its second quarter 2022 financial results and provide a business update. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our website shortly after conclusion of the ev
- Ascendis Pharma A/S Reports First Quarter 2022 Financial ResultsPhase 3 PaTHway Trial top-line results demonstrated potential of TransCon™ PTH to become the first parathyroid replacement therapy for adults with hypoparathyroidismTransCon PTH U.S. FDA regulatory submission on track for Q3 and EU MAA for Q4 2022 Increasing uptake of SKYTROFA® (lonapegsomatropin-tcgd), with more than 1,200 unique patient prescriptions processed as of April 29, 2022Completed U.S. $575 million convertible notes offering strengthening balance sheet to build a sustainable leading global biopharma company Conference call today at 4:30 pm ET COPENHAGEN, Denmark, May 11, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the fir
- Ascendis Pharma A/S Announces First Quarter 2022 Financial Results and Business Update Conference Call on May 11COPENHAGEN, Denmark, May 04, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) announced today that the company will hold a conference call and live webcast on Wednesday, May 11, 2022 at 4:30 p.m. Eastern Time (ET) to review its first quarter 2022 financial results and provide a business update. Conference Call Details DateWednesday, May 11, 2022Time4:30 p.m. ET/1:30 p.m. Pacific TimeDial In (U.S.)844-290-3904Dial In (International)574-990-1036Access Code6876568 A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusi
- Ascendis Pharma A/S Announces Phase 3 PaTHway Trial of TransCon™ PTH in Adults with Hypoparathyroidism Met Primary and All Key Secondary Endpoints– For the primary composite endpoint, TransCon PTH demonstrated a response rate of 78.7% compared to 4.8% for control (p-value <0.0001). – TransCon PTH demonstrated statistically significant improvements compared to control on all key secondary endpoints, which included measures evaluating patient-reported disease symptoms and impacts. – TransCon PTH was generally well-tolerated, with no discontinuations related to study drug. – On track to submit NDA during the third quarter and MAA during the fourth quarter of 2022. – Conference call Monday, March 14th at 8:00 am ET. COPENHAGEN, Denmark, March 13, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that t
- Ascendis Pharma A/S Reports Full Year 2021 Financial Results and Provides a Business Update- Top-line results from PaTHway, a Phase 3 randomized study evaluating the safety, tolerability, and efficacy of TransCon™ PTH in adult hypoparathyroidism (HP) patients on track for this quarter - Demand for SKYTROFA® (lonapegsomatropin-tcgd), the only FDA-approved once-weekly somatropin, continues to grow in the U.S. - Conference call today at 4:30 pm ET COPENHAGEN, Denmark, March 02, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced financial results for the full year ended December 31, 2021 and provided a business update. "2021 was an extraordinary year for Ascendis, and we expect that 2022 will be even stronger. The regulatory approvals of TransCon
- Ascendis Pharma A/S Announces Full Year 2021 Financial Results and Business Update Conference Call on March 2COPENHAGEN, Denmark, Feb. 25, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the Company will hold a conference call and live webcast on Wednesday, March 2, 2022 at 4:30 p.m. Eastern Time (ET) to review its 2021 financial results and provide a business update. Conference Call Details DateWednesday, March 2, 2022Time4:30 p.m. Eastern Time/1:30 p.m. Pacific TimeDial In (U.S.)844-290-3904Dial In (International)574-990-1036Access Code2009938 A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusio
- Ascendis Pharma A/S Virtual R&D Program Update Highlights Continued Development Across R&D Pipeline–– TransCon™ PTH Phase 3 topline results expected in Q1 2022 and, if positive, planned NDA submission in Q3 2022 followed by expected MAA submission in Q4 2022 –– Enrollment completed in Phase 2 ACcomplisH Trial of TransCon CNP; blinded data informed dose selection of 50 and 100 μg/kg/week in dose expansion cohorts for ACcomplisH China Trial –– Early signs of clinical activity in three out of three efficacy-evaluable cancer patients treated with TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab COPENHAGEN, Denmark, Dec. 14, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today plans to provide an update on two of its investigational endocrinology rar
- Ascendis Pharma A/S to Host Virtual R&D Program Update on December 14COPENHAGEN, Denmark, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that the Company will host a virtual R&D Program Update for the investment community on Tuesday, December 14, 2021. The event will feature updates on Ascendis Pharma's endocrinology rare disease development programs and Ascendis' oncology product candidate TransCon TLR7/8 Agonist. Speakers include members of Ascendis senior management as well as a recognized expert in parathyroid disease, Aliya Khan, M.D., Clinical Professor of Medicine and Director of the Calcium Disorders Clinic at St. Joseph's Healthcare, McMaster University. Virtual R&D Program Update Conference Call & Webcast inf
- Ascendis Pharma A/S Announces Third Quarter 2021 Financial Results and Business Update Conference Call on November 10COPENHAGEN, Denmark, Nov. 03, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND), today announced that the Company will hold a conference call and live webcast on Wednesday, November 10, 2021 at 4:30 p.m. Eastern Time (ET) to review its third quarter 2021 financial results and provide a business update. Conference Call Details DateWednesday, November 10, 2021Time4:30 p.m. Eastern Time/1:30 p.m. Pacific TimeDial In (U.S.)844-290-3904Dial In (International)574-990-1036Access Code2357838 A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website
- Ascendis Pharma A/S Reports Second Quarter 2021 Financial Results– Announced U.S. Food and Drug Administration Approval of SKYTROFA® (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency – – Exceeded target enrollment in Phase 3 PaTHway Trial for TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism (HP); top-line results expected in Q1 2022 – – Initiated combination therapy arm in transcendIT-101; TransCon TLR7/8 Agonist used in combination with a check point inhibitor (CPI) – – Conference call today at 4:30 p.m. Eastern Time – COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative Tr
- Ascendis Pharma A/S Announces U.S. Food and Drug Administration Approval of SKYTROFA® (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency- SKYTROFA, the first FDA approved treatment utilizing TransCon™ technology, is a long-acting prodrug of somatropin that releases the same somatropin used in daily therapies – - Once weekly SKYTROFA demonstrated higher annualized height velocity (AHV) at week 52 compared to a daily growth hormone with similar safety and tolerability – - Availability in the U.S. expected shortly supported by a full suite of patient support programs – - Ascendis Pharma to host investor conference call today, Wednesday, August 25 at 4:30 p.m. E.T. - COPENHAGEN, Denmark, Aug. 25, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative Tr
- Ascendis Pharma A/S Announces Second Quarter 2021 Financial Results and Business Update Conference Call on August 25COPENHAGEN, Denmark, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, today announced that the company will hold a conference call and live webcast on Wednesday, August 25, 2021 at 4:30 p.m. Eastern Time (ET) to review its second quarter 2021 financial results and provide a business update. Conference Call Details DateWednesday, August 25, 2021Time4:30 p.m. ET/1:30 p.m. Pacific TimeDial In (U.S.)844-290-3904Dial In (International)574-990-1036Access Code8553236 A live webcast of the conference call will be available on the Invest