The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for TransCon ® CNP (navepegritide) for the treatment of children with achondroplasia, a rare ...

Ascendis Pharma announced that the FDA has accepted its New Drug Application for TransCon CNP, a treatment for children with achondroplasia, for priority review.

Shares of Ascendis Pharma AS (NASDAQ:ASND) rose 5.8% after the U.S. Food and Drug Administration (FDA) accepted the company’s ...

Ascendis Pharma A/S (Nasdaq: ASND) today announced new data showing improvements in growth and bone morphometry from Week 52 of its pivotal ApproaCH Trial of TransCon CNP (navepegritide ...

COPENHAGEN - Ascendis ... of TransCon CNP as a treatment for children with achondroplasia, aiming to improve their growth outcomes and overall quality of life. Ascendis Pharma plans to further ...

Ascendis Pharma's President and Chief Executive Officer. "We look forward to potential approvals of our third product, TransCon CNP, as a monotherapy in children with achondroplasia, and we believe ...

Ascendis Pharma’s President and Chief Executive Officer. “We look forward to potential approvals of our third product, TransCon CNP, as a monotherapy in children with achondroplasia ...

Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for TransCon CNP (navepegritide) for the ...

COPENHAGEN, Denmark, March 31, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New Drug Application (NDA) to the U.S. Food & Drug Administration ...

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 ... of 2025,” said Jan Mikkelsen, ...

Also Read: Ascendis Pharma Faces Challenges With Skytrofa And Yorvipath Pricing: Analysts Weigh In. In the trial, children treated with once-weekly TransCon CNP demonstrated annualized growth ...