Ascendis Pharma (ASND) reports positive Phase 2 Turner syndrome trial results

Rhea-AI Filing Summary

Ascendis Pharma A/S reported positive Week 52 topline results from New InsiGHTS, a Phase 2 clinical trial in the U.S. The study compared once-weekly TransCon hGH (lonapegsomatropin) with daily somatropin in prepubertal children with Turner syndrome.

The trial enrolled and dosed 49 children aged 1 to 10 years, who received either the weekly or daily growth hormone regimen. Doses for both treatments were then individualized based on IGF-1 levels to tailor therapy for each child.

Insights

Biotech clinical-trials analyst

Positive Phase 2 topline Turner-syndrome data, but details and next steps are not yet shown.

Ascendis Pharma reported positive Week 52 topline results from its New InsiGHTS Phase 2 trial of once-weekly TransCon hGH versus daily somatropin in children with Turner syndrome. The drug is already approved for growth hormone deficiency, so this explores a new indication.

The study randomized 49 prepubertal children aged 1 to 10 years to weekly or daily growth hormone, with dosing individualized based on IGF-1. The excerpt does not provide specific efficacy or safety metrics, so the scale of benefit and risk is unclear from this text alone.

Future detailed disclosures about growth outcomes, safety findings, and any planned Phase 3 program in Turner syndrome would clarify how these results might support potential label expansion or regulatory discussions.

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 March, 2026

Commission File Number: 001-36815

Ascendis Pharma A/S

(Translation of registrant’s name into English)

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 ☐

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, 333-254101, 333-261550, 333-270088, 333-277519, 333-281916, 333-285322 and 333-293854) and Form F-3 (Registration Numbers 333-209336, 333-211511, 333-216882, 333-223134, 333-225284, 333-256571 and 333-282196) of Ascendis Pharma A/S (the “Company” or “Ascendis”) (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 March 17, 2026, the Company announced positive Week 52 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. investigating the safety, tolerability, and efficacy of once-weekly TransCon hGH (lonapegsomatropin; U.S. FDA-approved for pediatric and adult growth hormone deficiency (GHD) and approved in other territories for pediatric GHD) compared to daily somatropin in prepubertal children with Turner syndrome.

New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old. They were treated with either TransCon hGH or daily somatropin. Doses were subsequently individualized based on IGF-1.

• At Week 52, children treated with TransCon hGH demonstrated improved annualized height velocity (AHV) similar to daily somatropin, independent of starting dose, with an LS mean AHV of 9.05 cm/year for all TransCon hGH-treated children, compared to 9.04 cm/year for those treated with daily somatropin.

• At Week 52, the mean dose for TransCon hGH was 0.22 mg/kg/week, while the mean dose for the daily somatropin cohort was 0.29 mg/kg/week.

• In the trial, TransCon hGH demonstrated a safety and tolerability profile similar to daily somatropin through follow-up of up to 143 weeks. Adverse events (AEs) were mild to moderate in severity, with no AEs leading to discontinuation of study drug. There were no occurrences of slipped capital femoral epiphysis (SCFE), consistent with the low rate of occurrence (<1%) in long-term safety data of daily somatropin use in Turner syndrome from published literature^1,2.

¹  Darendeliler F, Karagiannis G, Wilton P. Horm Res. 2007;68 Suppl 5:41-47. doi:10.1159/000110474

²  Bell J, Parker KL, Swinford RD, et al. J Clin Endocrinol Metab 2010;95(1):167–177. doi:10.1210/jc.2009-0178.

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: March 17, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer

FAQ

What did Ascendis Pharma (ASND) announce in its March 2026 Form 6-K?

Ascendis Pharma announced positive Week 52 topline results from its New InsiGHTS Phase 2 trial. The study tested once-weekly TransCon hGH versus daily somatropin in prepubertal children with Turner syndrome in the U.S., focusing on safety, tolerability, and efficacy outcomes.

What is the New InsiGHTS Phase 2 trial mentioned by Ascendis Pharma (ASND)?

New InsiGHTS is a Phase 2 randomized, open-label, active-controlled trial in the U.S. It evaluates safety, tolerability, and efficacy of once-weekly TransCon hGH compared with daily somatropin in prepubertal children with Turner syndrome, providing Week 52 topline results in this report.

How many patients were enrolled in Ascendis Pharma’s New InsiGHTS Turner syndrome study?

The New InsiGHTS trial randomized and dosed 49 children with Turner syndrome. These prepubertal patients were between 1 and 10 years old and were treated with either once-weekly TransCon hGH or daily somatropin, with doses individualized based on IGF-1 levels.

What treatment was evaluated in Ascendis Pharma’s Turner syndrome Phase 2 trial?

The trial evaluated once-weekly TransCon hGH (lonapegsomatropin) compared with daily somatropin. TransCon hGH is already approved in the U.S. for pediatric and adult growth hormone deficiency and in other territories for pediatric growth hormone deficiency, and here it is tested in Turner syndrome.

For which conditions is TransCon hGH already approved, according to Ascendis Pharma?

TransCon hGH (lonapegsomatropin) is approved for growth hormone deficiency. It holds U.S. FDA approval for pediatric and adult growth hormone deficiency and approvals in other territories for pediatric growth hormone deficiency, while New InsiGHTS explores its use in children with Turner syndrome.

How were doses managed in Ascendis Pharma’s New InsiGHTS Turner syndrome trial?

Doses in New InsiGHTS were individualized based on IGF-1 levels. Children receiving once-weekly TransCon hGH or daily somatropin had their dosing adjusted using this biomarker, aiming to tailor growth hormone therapy to each patient’s biological response over the 52-week period.