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Ascendis Pharma A/S Announces Key Updates and Achievements in 2024

Ascendis Pharma A/S has provided a comprehensive update on its business and strategic roadmap, including significant milestones for 2025, participation in the 43rd Annual J.P. Morgan Healthcare Conference, and the commercial availability of YORVIPATH® in the United States. The company also announced positive results from the New InsiGHTS trial and the FDA's acceptance of its supplemental Biologics License Application for TransCon™ hGH.

Business and Strategic Roadmap Update

Ascendis Pharma A/S (Nasdaq: ASND) has outlined its plans for 2025, emphasizing its position for rapid revenue growth. The company's President and CEO, Jan Mikkelsen, is set to present these updates at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025.

Participation in the 43rd Annual J.P. Morgan Healthcare Conference

Company executives will participate in the conference, with a live webcast available for investors. This event is a key platform for discussing Ascendis Pharma's strategic direction and future milestones.

Commercial Availability of YORVIPATH®

YORVIPATH® (palopegteriparatide), the first and only FDA-approved medicine for treating hypoparathyroidism in adults, is now available in the United States. This marks a significant milestone in the treatment of this condition.

New InsiGHTS Trial Results

Positive Week 26 topline results from the New InsiGHTS trial of TransCon™ hGH in Turner Syndrome have been announced. The trial achieved its primary objective, showing a safety and tolerability profile comparable to daily somatropin.

FDA Acceptance of Supplemental Biologics License Application

The FDA has accepted Ascendis Pharma's supplemental Biologics License Application for TransCon™ hGH for the treatment of adults with growth hormone deficiency, setting a PDUFA goal date of July 27, 2025.

Collaboration with Novo Nordisk

Ascendis Pharma has entered into a collaboration with Novo Nordisk for the development and commercialization of TransCon technology-based products in metabolic and cardiovascular diseases, leveraging Ascendis' proprietary technologies and Novo Nordisk's expertise.

Financial Results and Business Update

Ascendis Pharma reported its third quarter 2024 financial results, highlighting the launch of YORVIPATH in the U.S. and the planned NDA submission for TransCon CNP for achondroplasia. The company also provided a business update, discussing its financial health and strategic initiatives.
These updates and achievements underscore Ascendis Pharma's commitment to advancing its product pipeline and strategic partnerships, positioning the company for continued growth and success in the pharmaceutical industry.
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Ascendis Pharma Announces Progress Across Endocrinology and Oncology Programs in Q3 2024

Ascendis Pharma's YORVIPATH is set to launch in the U.S. by mid-January 2025, with significant revenue growth reported ex-U.S. in Q3 2024.
The company plans to submit an NDA for TransCon CNP to the FDA in Q1 2025 for treating achondroplasia in children, followed by an MAA submission to the EMA in Q3 2025.

Novo Nordisk Enters Agreement with Ascendis Pharma for Monthly GLP-1 Agonist

Novo Nordisk secures exclusive global rights to Ascendis Pharma's TransCon technology for developing treatments for metabolic diseases, including obesity and type 2 diabetes.
The lead project focuses on a once-monthly GLP-1 receptor agonist, initially targeting obesity and type 2 diabetes, with potential expansion into other therapeutic areas.

Ascendis Pharma Seeks FDA Approval for TransCon hGH in Adult Growth Hormone Deficiency

Ascendis Pharma has submitted a supplemental Biologics License Application (sBLA) to the FDA for TransCon hGH to treat adults with growth hormone deficiency (GHD).
The sBLA is based on positive results from the Phase 3 foresiGHt trial, which demonstrated TransCon hGH's efficacy and safety in adults with GHD.

TransCon CNP Demonstrates Superior Growth Velocity in Achondroplasia Trial

Ascendis Pharma's TransCon CNP (navepegritide) met its primary endpoint in the ApproaCH trial, showing superior annualized growth velocity (AGV) compared to placebo in children with achondroplasia.
The overall AGV difference was 1.49 cm/year (p<0.0001), with a more significant difference of 1.78 cm/year (p<0.0001) observed in children aged 5-11 years.

Ascendis Pharma's Yorvipath Receives Orphan Drug Exclusivity in the U.S. for Hypoparathyroidism

Ascendis Pharma's Yorvipath (palopegteriparatide) has been granted Orphan Drug Exclusivity by the U.S. FDA for treating hypoparathyroidism in adults.
The exclusivity provides seven years of market protection in the U.S., preventing similar drugs from being marketed for the same indication.

Ascendis Pharma Gains Optimism with Potential Drug Launches and Analyst Upgrade

Oppenheimer upgraded Ascendis Pharma to Outperform, projecting strong sales for Yorvipath and potential in TransCon CNP.
Yorvipath, a hypoparathyroidism treatment, anticipates a U.S. launch by Q1 2025, driven by positive feedback from key opinion leaders.

FDA Approves Yorvipath (palopegteriparatide) for Hypoparathyroidism

The FDA has approved Yorvipath (palopegteriparatide) as a treatment for adults with hypoparathyroidism, offering a new therapeutic option.
Yorvipath is developed by Ascendis Pharma using their TransCon technology, designed to provide a potentially best-in-class therapy.

Ascendis Pharma Unveils Vision 2030 Strategic Roadmap

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Ascendis Pharma A/S Updates on Vision 3x3 Strategy and 2022 Milestones

Ascendis Pharma A/S provided an update on its Vision 3x3 strategic roadmap and key milestones for 2022 at the 40th Annual J.P. Morgan Healthcare Conference. The company highlighted its progress in 2021, including the U.S. launch of SKYTROFA®, and outlined its plans for clinical data readouts and regulatory submissions across its endocrinology rare disease and oncology portfolios in 2022.

Reference News

[1]
Ascendis Pharma A/S (ASND) Latest Stock News & ...
ca.finance.yahoo.com · Jan 13, 2025

Ascendis Pharma updates on rapid revenue growth and strategic milestones at the J.P. Morgan Healthcare Conference. YORVI...

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