Ascendis Pharma A/S

08/26/2021 | Press release | Distributed by Public on 08/27/2021 00:52

INCORPORATION BY REFERENCE (Form 6-K)

INCORPORATION BY REFERENCE

This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-203040,333-210810,333-211512,333-213412,333-214843,333-216883,333-228576 and 333-254101) and Form F-3 (Registration Numbers 333-209336,333-211511,333-216882,333-223134,333-225284 and 333-256571) of Ascendis Pharma A/S (the 'Company') (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

On August 25, 2021, the Company announced that the U.S. Food and Drug Administration (the 'FDA') has approved SKYTROFA® (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. As a once-weekly injection, SKYTROFA is the first FDA approved product that delivers somatropin (growth hormone) by sustained release over one week. 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.