Ascendis Pharma posts 2-year ApproaCH trial data

Ascendis Pharma A/S filed a Form 6-K highlighting new Week 104 radiographic data from its pivotal ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia.

Accepted by SEC EDGAR 06/30/2026 - 04:05 PM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

Ascendis Pharma A/S filed a Form 6-K highlighting new Week 104 radiographic data from its pivotal ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia. Children treated with TransCon CNP showed continued improvements in lower extremity alignment, including tibial-femoral angle, through up to two years of treatment.

The company notes that previously reported gains in annualized growth velocity and ACH-specific height Z-score were maintained through Week 104. TransCon CNP was generally well tolerated, with a low rate of mild injection site reactions, no symptomatic hypotension, no acceleration of bone age, and no adverse events leading to treatment discontinuation or withdrawal.

Insights

Biopharma clinical data analyst

Week 104 achondroplasia data extend safety and efficacy signals.

Ascendis Pharma reports two-year radiographic results from the pivotal ApproaCH Trial of TransCon CNP in pediatric achondroplasia. The design—a randomized, double-blind, placebo-controlled core period followed by an open-label extension—supports relatively robust assessment of both efficacy signals and longer-term safety.

The update stresses continued improvement in lower extremity alignment, including tibial-femoral angle, and maintenance of earlier gains in annualized growth velocity and ACH-specific height Z-score through Week 104. Tolerability appears consistent, with low, mild injection site reactions, no symptomatic hypotension, and no bone age acceleration, and no discontinuations due to adverse events.

These data, presented at the 12th International Conference on Children’s Bone Health in 2026, add durability information for TransCon CNP’s risk-benefit profile in children aged 2–11 years. Future regulatory or development steps are not detailed here and would need to be confirmed in subsequent company communications.

Key Figures

Trial participants: 84 children Patient age range: 2–11 years TransCon CNP dose: 100 µg/kg once-weekly +3 more

6 metrics

Trial participants 84 children Randomized pivotal ApproaCH Trial in achondroplasia

Patient age range 2–11 years Children enrolled in ApproaCH Trial

TransCon CNP dose 100 µg/kg once-weekly Investigational treatment regimen in ApproaCH Trial

Core trial duration 52 weeks Double-blind, placebo-controlled phase before open-label extension

Total follow-up 104 weeks Open-label extension with all participants on TransCon CNP

Conference edition 12th International Conference ICCBH 2026 where data were presented

Key Terms

radiographic, tibial-femoral angle (TFA), achondroplasia, open-label extension (OLE), +1 more

5 terms

radiographic medical

"announced new radiographic data from Week 104 from the completed pivotal ApproaCH Trial"

Relating to medical imaging produced by X-rays or other ionizing radiation, or to the images and findings seen on those scans. A radiographic result is the picture or description doctors and regulators use to show the presence, size, or change in a bone, organ, tumor, implant position, or other internal feature—like a photograph that reveals what’s happening inside the body. Investors see radiographic evidence cited when companies report diagnostic performance, treatment effect, or safety in clinical and regulatory documents.

tibial-femoral angle (TFA) medical

"including improvements in tibial-femoral angle (TFA)"

achondroplasia medical

"in children with achondroplasia"

A genetic condition that causes the most common form of short stature, where a specific change in a growth-control gene makes the long bones grow more slowly, producing a distinct body proportion and sometimes breathing, spinal or joint issues. It matters to investors because it defines a clear patient population, predictable medical needs and regulatory pathways for drugs or devices—similar to a niche market with steady, long-term demand for effective treatments or supportive care.

open-label extension (OLE) medical

"followed by an open-label extension (OLE) in which all participants received TransCon CNP"

An open-label extension (OLE) is a follow-up phase of a clinical trial where participants and researchers know the treatment being given, often after an initial blinded study. It allows for continued access to a promising therapy and provides additional safety and effectiveness data. For investors, it can signal ongoing interest in a treatment’s potential and help assess long-term benefits and risks.

injection site reactions (ISRs) medical

"with a low rate of ISRs (all mild)"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Ascendis Pharma (ASND) report in its June 2026 Form 6-K?

Ascendis Pharma reported new Week 104 radiographic data from its pivotal ApproaCH Trial of once-weekly TransCon CNP in children with achondroplasia. The filing highlights sustained improvements in lower extremity alignment, maintained growth benefits, and a generally well-tolerated safety profile over up to two years of treatment.

What is the ApproaCH Trial described in the Ascendis Pharma (ASND) filing?

The ApproaCH Trial is a randomized, double-blind, placebo-controlled pivotal study in 84 children with achondroplasia aged 2–11 years. It evaluated once-weekly TransCon CNP 100 µg/kg versus placebo for 52 weeks, followed by an open-label extension where all participants received TransCon CNP through Week 104.

What efficacy signals for TransCon CNP were highlighted by Ascendis Pharma (ASND)?

Ascendis highlighted continued improvements in lower extremity alignment, including tibial-femoral angle, through up to two years of TransCon CNP treatment. The company also noted that previously reported improvements in annualized growth velocity and increases in ACH-specific height Z-score were maintained through Week 104 in the ApproaCH Trial.

How was TransCon CNP tolerated in the ApproaCH Trial reported by Ascendis Pharma (ASND)?

TransCon CNP was described as generally well tolerated through up to two years of treatment. The filing notes a low rate of mild injection site reactions, no symptomatic hypotension, no acceleration of bone age, and that most adverse events were mild or moderate, with none causing treatment discontinuation or withdrawal.

Where were the new ApproaCH Trial Week 104 data from Ascendis Pharma (ASND) presented?

The Week 104 data from the ApproaCH Trial were presented by Leanne M. Ward, M.D., FRCPC, a Professor of Pediatrics, during the 12th International Conference on Children’s Bone Health (ICCBH 2026), which was held in Montreal, Canada, according to the company’s Form 6-K description.

How does the Ascendis Pharma (ASND) Form 6-K interact with its existing registration statements?

The Form 6-K is deemed incorporated by reference into Ascendis Pharma’s existing Form S-8 and Form F-3 registration statements. That means the information in this report becomes part of those registration statements from the date of filing, unless superseded by later documents.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of June, 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 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 June 30, 2026, the Company announced new radiographic data from Week 104 from the completed pivotal ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia. In the trial, TransCon CNP-treated children demonstrated continued improvements in lower extremity alignment through up to two years of treatment, including improvements in tibial-femoral angle (TFA). As previously reported, improvements in annualized growth velocity were maintained and ACH-specific height Z-score increased with TransCon CNP treatment through Week 104. The data were presented by Leanne M. Ward, M.D., FRCPC, Professor of Pediatrics at the University of Ottawa and Children’s Hospital of Eastern Ontario, during the 12th International Conference on Children’s Bone Health (ICCBH 2026) held in Montreal, Canada.

ApproaCH Trial Design

ApproaCH was a randomized, double-blind, placebo-controlled pivotal trial in 84 children with achondroplasia aged 2–11 years, investigating TransCon CNP (100 µg/kg once-weekly) versus placebo for 52 weeks, followed by an open-label extension (OLE) in which all participants received TransCon CNP through Week 104. Radiographic assessments of lower extremity alignment were conducted at baseline, Week 52, and Week 104.

Highlights of Radiographic Assessments at Week 104 of the Pivotal ApproaCH Trial

• Improvements in TFA and TFA Z-scores continued through Week 104 and were greater in children with baseline TFA ≥ 5°:

• The average TFA in all children treated with TransCon CNP during the double-blind period was 9.1° at baseline, decreasing to 7.7° at Week 52 and 6.9° at Week 104, reflecting a mean absolute change of -2.2 degrees over the two-year treatment period. In the subgroup of children with baseline TFA ≥ 5° (reflecting children with preexisting genu varum), the average TFA was 13.4° at baseline, decreasing to 11.3° at Week 52 and 9.6° at Week 104, reflecting a mean absolute change of -3.8 degrees over the two-year treatment period.

• The average TFA in children switching from placebo to TransCon CNP treatment at Week 52 was 11.5° at baseline, increasing to 11.8° at Week 52 and decreasing with TransCon CNP treatment to 10.1° at Week 104, reflecting a mean absolute change of -1.7 degrees during the OLE period. In the subgroup of children with baseline TFA ≥ 5°, the average TFA was 18.2° at baseline, increasing to 18.7° at Week 52 and decreasing with treatment to 14.9° at Week 104, reflecting a mean absolute change of -3.8 degrees during the OLE period.

• In children treated with TransCon CNP in the double-blind period, mean TFA Z-score was 3.62 at baseline and decreased to 3.15 at Week 52 and 2.96 at Week 104, reflecting a mean absolute change of -0.66 over the two-year treatment period. In the subgroup of children with baseline TFA ≥ 5°, mean TFA Z-score was 5.40 at baseline and decreased to 4.67 at Week 52 and 4.36 at Week 104, reflecting a mean absolute change of -1.04 over the two-year treatment period.

• In children switching from placebo to TransCon CNP at Week 52, mean TFA Z-score was 4.08 at baseline, increased to 4.76 at Week 52, and decreased to 4.28 at Week 104, reflecting a mean absolute change of -0.48 from Week 52 to Week 104. In the subgroup of children with baseline TFA ≥ 5°, mean TFA Z-score was 6.13 at baseline, increased to 7.56 at Week 52, and decreased to 6.35 at Week 104, reflecting a mean absolute change of -1.21 from Week 52 to Week 104.

• Results also showed that fibula-to-tibia length ratio remained stable in the overall clinical trial population during the open-label extension, reflecting proportional growth of the lower leg.

Through up to two years of treatment, TransCon CNP was generally well tolerated, with a low rate of ISRs (all mild), no symptomatic hypotension, and no acceleration of bone age. Most adverse events in TransCon CNP-treated children were mild or moderate, with none leading to treatment discontinuation or withdrawal from the trial.

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: June 30, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer