logo
  

Ascendis Pharma Q2 Loss Widens; FDA Approves Skytrofa To Treat Pediatric Growth Hormone Deficiency

Ascendis Pharma A/S (ASND) reported that its second-quarter net loss widened from last year. In addition, the company said that the U.S. Food and Drug Administration approved its Skytrofa for the treatment of Pediatric Growth Hormone Deficiency.

Ascendis Pharma noted that the FDA approved Skytrofa or lonapegsomatropin-tcgd for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH).

The company said it is actively preparing for the U.S. commercial launch of Skytrofa for the treatment of children with growth hormone deficiency, which is now the first FDA-approved once-weekly treatment for pediatric growth hormone deficiency.

The company stated that the once-weekly treatment could reduce treatment burden and potentially replace the daily somatropin therapies, which have been the standard of care for over 30 years.

The approval includes the new Skytrofa Auto-Injector and cartridges which, after first removed from a refrigerator, allow families to store the medicine at room temperature for up to six months.

Ascendis Pharma reported that its second-quarter net loss widened to 134.4 million euros or 2.50 euros per share from 94.9 million euros or 1.97 euros per share last year.

Revenue for the second quarter declined to 1.0 million euros from last year's 1.4 million euros, due to a lower amount of license revenue being recognized, partly offset by higher sale of clinical supplies and services to VISEN and recognition of revenue from services rendered to another collaboration partner.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Caterpillar Inc. (CAT), a manufacturer of mining and construction equipment, reported Friday that fourth-quarter net income more than doubled to $2.12 billion or $3.91 per share from $780 million or $1.42 per share in the prior-year quarter. Excluding special items, adjusted net income for the quarter... United Airlines has opened its flight training school, United Aviate Academy, to bring out new pilots with a view to mainly empower women and people of color. The institute's first class of students is 80 percent women or people of color. This outpaces the airline's earlier goal to train about 5,000 new pilots at the school by 2030 with at least half being women or people of color. French telecom major Orange SA (ORAN) announced Friday that the company's Board of Directors, which met today, has appointed Christel Heydemann as the Chief Executive Officer of Orange with effect from April 4. The Board has asked Stéphane Richard to continue as Chairman & CEO until Heydemann takes...
Follow RTT