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 ...

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 ...

Many subcutaneous drugs are administered via an easy to use pen injector device ... Ascendis. His comment was extremely helpful in that it brought into focus what differentiates TransCon CNP ...

A slide presentation with these data can be found on the Investor Relations & News section of the Ascendis Pharma website: https://investors.ascendispharma.com. TransCon CNP demonstrated a ...

Early data indicates that TransCon CNP could challenge Voxzogo's market share by late 2025. Ascendis' TransCon CNP stands out due to its once-weekly dosing schedule and potentially improved safety ...

• Data demonstrate significant improvements in well-being and physical functioning compared to placebo in patients treated for 1 year with TransCon CNP at the pivotal 100µg/kg/week dose ...

Ascendis Pharma has ... that need with its CNP analog Voxzogo—the centerpiece of its growth strategy—but that drug needs to be injected once a day. Ascendis’ TransCon CNP could challenge ...

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 ...

16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced topline data from the pivotal double-blind placebo-controlled ApproaCH Trial of TransCon CNP (navepegritide), which ...

Ascendis Pharma has pocketed $70 million ... the rights to use Skytrofa—also known as TransCon hGH—along with TransCon PTH and TransCon CNP to treat endocrinology rare disease in Japan.

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 ...