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... Read More

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... Read More

Launch of TransCon™ PTH underway with full commercial availability in Germany and Austria; U.S. PDUFA date of May 14, 2024 TransCon CNP pivotal ApproaCH Trial on track for topline results in Q4 2024 Total 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... Read More

COPENHAGEN, Denmark, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference. Details: Event Oppenheimer 34th Annual Healthcare Life Sciences Conference Location Virtual Date Tuesday, February 13, 2024 Time 4:00 p.m. Eastern Time / 1:00 p.m. Pacific Time A live webcast of the event will be... Read More

COPENHAGEN, 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... Read More

COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH ® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria. YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology platform... Read More

COPENHAGEN, Denmark, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the formation and launch with Frazier Life Sciences of Eyconis, Inc., a separate company created to develop, manufacture, and commercialize TransCon ophthalmology assets globally, together with an investor syndicate that includes Frazier, RA Capital Management, venBio, and HealthQuest Capital. Ascendis Pharma has granted... Read More

DUBAI, United Arab Emirates, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Vector Pharma FZCO (Vector) today announced that it has entered into an exclusive distribution agreement with Danish company Ascendis Pharma A/S (Nasdaq: ASND) to commercialize both Skytrofa ™ and Yorvipath ™ in the Gulf Cooperation Council (GCC) countries of Saudi Arabia, United Arab Emirates, Kuwait, Oman, Qatar and Bahrain. Under the terms of this exclusive... Read More

Strategic roadmap to achieve blockbuster status for multiple products and expand the Company’s engine for future innovation COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42 nd Annual... Read More

Agreement between Ascendis Pharma A/S and ST is for the exclusive distribution and commercialisation of three Ascendis Pharma endocrinology therapies Two of the therapies are already internationally approved, the third is in development following successful Phase 2 data ST's exclusive distribution agreement covers Australia , New Zealand , Singapore , Malaysia , Brunei , Thailand and Vietnam SINGAPORE , Jan. 7, 2024... Read More

COPENHAGEN, Denmark, Dec. 28, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that Jan Mikkelsen, President & Chief Executive Officer, Scott Smith, Executive Vice President & Chief Financial Officer, and Kennett Sprogøe, Ph.D., Executive Vice President, Head of Research & Product Development, will participate in the 42 nd Annual J.P. Morgan Healthcare Conference. Details: Event 42 nd Annual J.P.... Read More

TransCon CNP is the first investigational product to demonstrate improvements in health-related quality of life and disease impacts in children with achondroplasia COPENHAGEN, Denmark, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new analyses from the blinded and ongoing open-label extension (OLE) portions of ACcomplisH, the Company’s Phase 2 randomized, double-blind,... Read More

On primary efficacy and key secondary endpoints, TransCon hGH demonstrated statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo TransCon hGH was generally safe and well tolerated, similar to daily hGH, with no discontinuations related to study drug Exploratory post-hoc analysis suggests the same treatment effects on target tissues as daily hGH... Read More

PDUFA goal date is May 14, 2024 COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2... Read More

Teijin to receive exclusive license to further develop and commercialize TransCon™ hGH, TransCon™ PTH, and TransCon™ CNP in Japan Ascendis Pharma is eligible to receive $70 million upfront, development/regulatory milestones of up to $175 million, transfer pricing, and commercial milestones Ascendis Pharma is also eligible to receive royalties on net sales in Japan, of up to mid-20’s percent, varying by product COPENHAGEN,... Read More

YORVIPATH (developed as TransCon PTH) is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism Ascendis plans its first EU launch of YORVIPATH in Germany in January 2024 COPENHAGEN, Denmark, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH ®... Read More

COPENHAGEN, Denmark, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has resubmitted its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adults with hypoparathyroidism to the U.S. Food & Drug Administration (FDA). The resubmission follows the Type A meeting held with the FDA in late August. “Research has shown that parathyroid hormone (PTH)... Read More

European Commission decision for TransCon ™ PTH expected this month; if approved, first European Union launch planned in Germany in January 2024 TransCon PTH NDA resubmission to FDA expected before mid-November Completed 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... Read More

Third Quarter financial results and business update conference call to be held on November 7, 2023 Resubmission of TransCon PTH NDA for adults with hypoparathyroidism expected before mid-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... Read More

Clinical responses with TransCon IL-2 β⁄γ demonstrated as monotherapy or in combination with checkpoint inhibitor, including in two of three small cell lung cancer patients treated with combination therapy TransCon IL-2 β⁄γ administered every three weeks was generally well tolerated as a monotherapy or in combination with pembrolizumab, with no meaningful effect on T regs and eosinophils Enrollment continues in... Read More

At Week 26, 81% of patients in Phase 3 PaTHway Trial with chronic post-surgical hypoparathyroidism, the most common cause of this disease, achieved independence from conventional therapy while maintaining normocalcemia following treatment with TransCon PTH Post-surgical patients treated with TransCon PTH self-reported significant improvements in disease-related symptoms, physical functioning, and daily life compared to those... Read More

The majority of children and adolescents treated once weekly with TransCon hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of treatment completion or last visit Trial demonstrated the long-term safety of TransCon hGH in patients treated up to 6 years COPENHAGEN, Denmark, Sept. 23, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced results from enliGHten, the Company’s... Read More

COPENHAGEN, Denmark, Sept. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the launch in Germany of SKYTROFA ® (lonapegsomatropin), its growth hormone approved in the European Union for the once-weekly treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient endogenous growth hormone secretion (growth hormone deficiency, or GHD). “SKYTROFA is designed to... Read More

Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union launch planned in Germany in early 2024 COPENHAGEN, Denmark, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended the approval of TransCon... Read More

Approximately 50% of Phase 3 PaTHway Trial patients with eGFR < 60 mL/min/1.73m 2 , the threshold for kidney dysfunction, receiving TransCon PTH experienced eGFR improvement to above 60 mL/min/1.73m 2 COPENHAGEN, Denmark, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new post hoc analysis showing adults with hypoparathyroidism treated with TransCon PTH demonstrated substantial... Read More

Proceeds to support continued development and commercialization of Endocrine Rare Disease products, and general corporate purposes COPENHAGEN, Denmark and NEW YORK, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) and Royalty Pharma plc (Nasdaq: RPRX) today announced that Ascendis has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma based on U.S. net SKYTROFA... Read More

Expect to resubmit NDA to FDA for TransCon™ PTH in October 2023; EC decision on MAA for TransCon PTH expected during the fourth quarter of 2023 U.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 2024 Raising full year 2023 U.S. SKYTROFA ® * revenue expectations to €165 - €170... Read More

COPENHAGEN, Denmark, Aug. 24, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that Jan Mikkelsen, President & Chief Executive Officer, and Scott Smith, Executive Vice President & Chief Financial Officer, will participate in three upcoming investor conferences. Details: Event Citi’s 18th Annual BioPharma Conference Location Boston, MA Date Thursday, September 7, 2023 Time 2:40-3:25 p.m. Eastern... Read More

COPENHAGEN, 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... Read More

Oral presentation of results showed sustained improvements through Week 52, as well as safety and tolerability similar to that previously reported for the initial 26-week blinded portion of the Phase 3 PaTHway Trial At Week 52, 95% of patients treated with TransCon PTH achieved independence from conventional therapy TransCon PTH treatment improved mean patient-reported disease symptom and health-related quality of life... Read More

Endocrinology clinical development progress and research in growth hormone deficiency, hypoparathyroidism, achondroplasia, and Turner Syndrome will be highlighted Phase 3 Week 52 data for TransCon ™ PTH in adults with hypoparathyroidism selected for oral presentation COPENHAGEN, Denmark, June 13, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will showcase its latest Endocrinology Rare Disease... Read More

COPENHAGEN, Denmark, June 07, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that Jan Mikkelsen, President & Chief Executive Officer, and Scott Smith, Executive Vice President & Chief Financial Officer, will participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Tuesday, June 13. Details: Event Goldman Sachs 44th Annual Global Healthcare Conference... Read More

Compassionate use enables treating physicians in Germany to request access to investigational TransCon PTH (palopegteriparatide) for eligible adult patients with hypoparathyroidism COPENHAGEN, Denmark, June 05, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has started enrollment for a Compassionate Use Program (CUP) in Germany for TransCon PTH (palopegteriparatide), an investigational... Read More

TransCon IL-2 β/γ in Phase 1 clinical trial showed monotherapy clinical activity in heavily pre-treated cancer patients with clear dose dependent response on cytotoxic immune cells TransCon IL-2 β/γ administered every 3 weeks was generally well tolerated, with no meaningful effect on T regs and eosinophils. At the TransCon IL-2 β/γ recommended Phase 2 dose (RP2D), no dose limiting toxicity (DLT), vascular leak syndrome, or... Read More

COPENHAGEN, Denmark, May 25, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the company will host an Oncology program update for the investment community on Wednesday, May 31, 2023 in New York from 10:00 a.m. to 12:00 p.m. Eastern Time. The event will feature presentations by an outside oncology expert and Ascendis senior management on the company’s two immuno-oncology product candidates,... Read More

COPENHAGEN, Denmark, May 13, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the company will present clinical and research outcomes in hypoparathyroidism and growth hormone deficiency, and host informational booth and events, at ECE 2023, the European Congress of Endocrinology being held May 13-16 in Istanbul, Turkey. ECE gathers international professionals to share the latest science and... Read More

COPENHAGEN, Denmark, May 03, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that Jan Mikkelsen, President & Chief Executive Officer, and Scott Smith, Executive Vice President & Chief Financial Officer, will participate in a virtual fireside chat at the BofA Securities 2023 Health Care Conference on Tuesday, May 9. Details: Event BofA Securities 2023 Health Care Conference Location Las Vegas, NV... Read More

FDA 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 letter Ascendis 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... Read More

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... Read More

COPENHAGEN, 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... Read More

COPENHAGEN, Denmark, April 03, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that initial dose escalation data from the Company’s ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ alone or in combination with pembrolizumab has been accepted for online publication at ASCO 2023, the annual meeting of the American Society of Clinical Oncology being held June 2-6 in Chicago. TransCon IL-2 β/γ... Read More

COPENHAGEN, 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... Read More

COPENHAGEN, Denmark, March 10, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that Jan Mikkelsen, President & Chief Executive Officer, and Scott Smith, Executive Vice President & Chief Financial Officer, will participate in a virtual fireside chat at the Oppenheimer 33rd Annual Healthcare Conference on Wednesday, March 15. Details: Event Oppenheimer 33rd Annual Healthcare Conference Location... Read More

TransCon™ PTH PDUFA date of April 30, 2023, for adults with hypoparathyroidism; European MAA decision expected in the fourth quarter of 2023 Expanding 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... Read More

COPENHAGEN, 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... Read More

On track to fulfill all elements of Vision 3x3 to build a sustainable, profitable, leading biopharma company COPENHAGEN, Denmark, Jan. 08, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today provided an update on its Vision 3x3 strategic roadmap and planned 2023 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 9, at the 41st Annual J.P. Morgan... Read More

The Expanded Access Program (EAP) allows physicians to request access to TransCon PTH, the company’s investigational parathyroid hormone replacement therapy, for eligible patients in the United States TransCon PTH is under Priority Review by the FDA, with a target PDUFA date of April 30, 2023 COPENHAGEN, Denmark, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the online portal is... Read More

COPENHAGEN, Denmark, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) announced today that the Company is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference. Details: Event 41st Annual J.P. Morgan Healthcare Conference Location San Francisco, CA Date Monday, January 9, 2023 Time 12:00-12:40 p.m. Eastern Time / 9:00-9:40 a.m. Pacific Time A live webcast of the event will be available... Read More

The program will allow physicians to request access to TransCon PTH, the company’s investigational parathyroid hormone replacement therapy, for eligible patients in the United States TransCon PTH is under Priority Review by the FDA, with a target PDUFA date of April 30, 2023 COPENHAGEN, Denmark, Dec. 05, 2022 (GLOBE NEWSWIRE) - - Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration... Read More