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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.

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