Is this U.S.-China selloff a buy? A top Wall Street voice weighs in
COPENHAGEN - Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company with a market capitalization of $12.8 billion and impressive 59% return over the past year according to InvestingPro, has submitted a Marketing Authorisation Application to the European Medicines Agency for TransCon CNP (navepegritide), a treatment for children with achondroplasia, the company announced Wednesday.
The application is based on data from three randomized, double-blind, placebo-controlled clinical trials and up to three years of open-label extension data, including results from the pivotal ApproaCH Trial. According to the company, TransCon CNP has been generally well tolerated in these trials, with no discontinuations related to the study drug. InvestingPro data shows nine analysts have recently revised their earnings expectations upward for the upcoming period, reflecting growing confidence in the company’s pipeline.
TransCon CNP is an investigational prodrug of C-type natriuretic peptide administered once weekly. It is designed to provide continuous inhibition of the overactive FGFR3 pathway in achondroplasia by delivering active CNP to receptors throughout the body.
"The achondroplasia community has been clear about its need for early pharmacological interventions that improve the medical, functional, and quality of life complications," said Aimee Shu, Executive Vice President of Endocrine & Rare Disease Medical Sciences and Chief Medical Officer at Ascendis Pharma.
Achondroplasia is a rare genetic condition affecting more than 250,000 individuals worldwide. It causes skeletal dysplasia and can lead to serious muscular, neurological, and cardiorespiratory complications.
In the United States, TransCon CNP is under priority review by the Food and Drug Administration with a target date of November 30, 2025.
The information in this article is based on a press release statement from Ascendis Pharma. With revenue growth of 54.5% in the last twelve months and strong price momentum, detailed financial analysis and additional insights are available in the comprehensive Pro Research Report on InvestingPro.
In other recent news, Ascendis Pharma reported its Q2 2025 earnings, exceeding expectations with an earnings per share (EPS) of -0.82 compared to the anticipated -1.27, representing a 35.43% surprise. The company’s revenue also surpassed forecasts, reaching €158 million against the expected €142.38 million, an 11.01% increase. Additionally, Ascendis Pharma’s Yorvipath global launch in hypoparathyroidism is showing strong initial results, with BofA Securities maintaining its Buy rating and a $230.00 price target, citing the company as a top pick for 2025. The firm anticipates further growth as payor coverage expands. UBS has also reiterated its Buy rating for Ascendis Pharma with a $307.00 price target, following competitor MBX’s clinical trial results. These developments reflect positive momentum for Ascendis Pharma, as noted by analysts.
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