Ascendis Pharma A/S 6-K, filed May 23, 2022
Ascendis Pharma A/S (ASND)
About this 6-K
Ascendis Pharma A/S filed this 6-K on May 23, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May, 2022
Commission File Number: 001-36815
Ascendis Pharma A/S
(Exact Name of Registrant as Specified in Its Charter)
Tuborg Boulevard 12
DK-2900 Hellerup
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
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 333-228576, 333-203040, 333-210810, 333-211512, 333-213412, 333-214843, 333-216883, 333-254101, and 333-261550) 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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 May 23, 2022, the Company announced that results from its associate VISEN Pharmaceuticals’ Phase 3 trial of once-weekly TransCon hGH in children with growth hormone deficiency in China demonstrated results that were consistent with the Company’s earlier multi-national Phase 3 trial. VISEN Pharmaceuticals’ Phase 3 trial achieved its primary endpoint, with pediatric growth hormone deficiency patients treated with once-weekly TransCon hGH demonstrating greater annualized height velocity at 52-weeks (p=0.0010) compared to patients treated with daily growth hormone. In both the Company’s and Visen Pharmaceuticals’ Phase 3 trials, TransCon hGH data demonstrated statistical non-inferiority and superiority on the primary endpoint with comparable safety and tolerability to daily growth hormone.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Ascendis Pharma A/S | ||||||
| Date: May 23, 2022 | By: | /s/ Michael Wolff Jensen | ||||
| Michael Wolff Jensen | ||||||
| Senior Vice President, Chief Legal Officer | ||||||