New COACH trial Week 52 data for TransCon combo at Ascendis Pharma (ASND)

Rhea-AI Filing Summary

Ascendis Pharma A/S reports new Week 52 data from its Phase 2 COACH Trial, studying combination therapy with once-weekly TransCon CNP and once-weekly TransCon hGH in children with achondroplasia. The company states that TransCon hGH accelerated TransCon CNP’s benefits beyond linear growth, with substantial improvements in arm span, spinal canal dimensions, and lower limb alignment.

Ascendis notes previously reported Week 52 results from the same trial showing mean annualized growth velocity above the 97th percentile of average-stature children, with maintained safety and tolerability and no acceleration of bone age. The report is incorporated by reference into existing Form S-8 and Form F-3 registration statements and includes extensive forward-looking statement language outlining clinical, regulatory, manufacturing, commercial, and financial risks referenced to Ascendis’ Form 20-F and future SEC reports.

Insights

Biotech clinical development analyst

Ascendis shares additional Phase 2 COACH data for its TransCon combination in achondroplasia, but emphasizes substantial ongoing clinical and regulatory risks.

The new Week 52 COACH Trial findings suggest once-weekly TransCon CNP plus TransCon hGH may deliver benefits beyond height, including arm span, spinal canal, and lower limb alignment changes in children with achondroplasia. Earlier Week 52 data also indicated mean annualized growth velocity above the 97th percentile of average-stature children while maintaining safety and avoiding accelerated bone age.

However, the company highlights that these are still development-stage data subject to clinical and regulatory uncertainty. It lists numerous potential issues, including trial results that may not confirm earlier findings, regulatory delays or failures in major markets, manufacturing and supply challenges, and market access risks. Future outcomes will depend on later-stage trials, regulatory reviews, and commercialization factors described in its Form 20-F and future SEC submissions.

Key Figures

COACH Trial timepoint: Week 52 Report date: April 8, 2026 Growth velocity benchmark: 97th percentile

3 metrics

COACH Trial timepoint Week 52 Phase 2 COACH Trial combination therapy data cutoff

Report date April 8, 2026 Date Ascendis announced new COACH Trial data

Growth velocity benchmark 97th percentile Mean annualized growth velocity vs average-stature children in prior Week 52 results

Key Terms

TransCon hGH, TransCon CNP, Phase 2 COACH Trial, forward-looking statements, +1 more

5 terms

TransCon hGH medical

"new data demonstrating TransCon hGH accelerated TransCon CNP’s benefits beyond linear growth"

TransCon CNP medical

"TransCon hGH accelerated TransCon CNP’s benefits beyond linear growth"

TransCon CNP is an investigational long-acting medicine that slowly releases C-type natriuretic peptide (CNP), a naturally occurring molecule that can promote normal bone growth. Think of it as a timed-release patch that supplies a growth-supporting signal over days rather than a single dose. Investors watch such programs because clinical trial results, regulatory decisions, and eventual approval or commercial adoption can materially affect a company’s value and future revenue prospects.

Phase 2 COACH Trial medical

"Week 52 of the ongoing Phase 2 COACH Trial of combination therapy"

forward-looking statements regulatory

"This report contains forward-looking statements that involve substantial risks and uncertainties."

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

achondroplasia medical

"combination therapy with once-weekly TransCon CNP and once-weekly TransCon hGH 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.

Form 6-K: How Foreign Companies Report to the SEC →

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 April, 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 April 8, 2026, the Company announced new data demonstrating TransCon hGH accelerated TransCon CNP’s benefits beyond linear growth with substantial improvements in arm span, spinal canal dimensions, and lower limb alignment. The new data are from Week 52 of the ongoing Phase 2 COACH Trial of combination therapy with once-weekly TransCon CNP and once-weekly TransCon hGH in children with achondroplasia. Ascendis previously reported Week 52 COACH results that demonstrated mean annualized growth velocity exceeding the 97th-percentile of average stature children, without compromising safety or tolerability and with no acceleration of bone age.

New Data from Week 52 of the COACH Trial

• Unprecedented improvements in arm span observed at Week 52 with TransCon CNP and TransCon hGH combination therapy, a measure highly meaningful to the achondroplasia community, with the mean change from baseline in achondroplasia (“ACH”)-specific arm span Z-scores at Week 52 for TransCon CNP treatment-naïve and TransCon CNP-treated children in COACH were +1.02 and +0.66, respectively. The TransCon CNP treatment-naïve cohort improved +9.4 cm and the TransCon CNP-treated cohort improved +7.9 cm. By comparison, humeral gain by limb lengthening surgery is approximately 8 cm per arm and carries a high complication risk.¹

• Mean of L1-L5 average changes in interpedicular distance (“IPD”) for TransCon CNP treatment-naïve and TransCon CNP-treated children on combination therapy in COACH were +1.7 mm and +1.1 mm, respectively, compared to +0.6 mm for children on TransCon CNP monotherapy in ApproaCH. Improvements in IPD offer the potential to reduce nerve compression and pain that can result from a narrowed spinal column.

• For the TransCon CNP treatment-naïve cohort, the mean change in tibial femoral angle (“TFA”) Z-score was -0.86 with combination therapy at Week 52 in COACH and was -0.47 for TransCon CNP monotherapy at Week 52 in ApproaCH, indicating enhanced straightening of the legs. Children previously treated with long-term TransCon CNP monotherapy for an average of 2.56 years maintained in normal range for TFA Z-score.

• For the TransCon CNP treatment-naïve cohort, the mean change in TFA was -3.0 degrees with combination therapy in COACH and was -1.3 degrees for children on TransCon CNP monotherapy at Week 52 in ApproaCH. Children previously treated with long-term TransCon CNP monotherapy for an average of 2.56 years maintained TFA treatment benefit in the setting of accelerated growth.

• All children completed 52 weeks of treatment and remain on therapy in COACH as of today.

Forward-Looking Statements

This report contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements

include, but are not limited to, statements relating to the potential of TransCon CNP and TransCon hGH combination therapy as a differentiated therapy for short stature in the setting of growth hormone sufficiency. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third-party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on-market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom-to-operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (“SEC”) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

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: April 8, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer

FAQ

What new clinical data did Ascendis Pharma (ASND) report in this Form 6-K?

Ascendis reported new Week 52 data from its Phase 2 COACH Trial of once-weekly TransCon CNP plus TransCon hGH in children with achondroplasia. The company states the combination accelerated benefits beyond linear growth, improving arm span, spinal canal dimensions, and lower limb alignment versus prior expectations.

How did Ascendis Pharma (ASND) describe earlier COACH Trial results?

Ascendis previously reported Week 52 COACH Trial results showing mean annualized growth velocity above the 97th percentile for average-stature children. The company noted these findings were achieved without compromising safety or tolerability and without acceleration of bone age in the studied achondroplasia population.

What is the therapeutic goal of TransCon CNP and TransCon hGH for Ascendis Pharma (ASND)?

Ascendis describes the TransCon CNP and TransCon hGH combination as a potential differentiated therapy for short stature where growth hormone sufficiency is present. The aim is to address not only height but broader skeletal features in achondroplasia, based on the clinical endpoints highlighted in the Week 52 data.

How is this Ascendis Pharma (ASND) Form 6-K used in existing SEC registrations?

The report is incorporated by reference into Ascendis’ existing Form S-8 and Form F-3 registration statements, including any related prospectuses. From the filing date, it becomes part of those registrations unless later documents filed or furnished with the SEC supersede the information it contains.

What key risks did Ascendis Pharma (ASND) emphasize regarding these COACH Trial results?

Ascendis stresses that forward-looking statements involve substantial risks, including possible non-confirmation of trial results, regulatory delays or denials, manufacturing and supply challenges, commercialization costs, market access and competition, intellectual property issues, funding needs, and broader economic and geopolitical factors affecting its business.

Where can investors find more detailed risk information on Ascendis Pharma (ASND)?

The company directs readers to its Annual Report on Form 20-F filed with the SEC on February 11, 2026, and to future SEC reports. These documents provide expanded descriptions of business, clinical, regulatory, financial, and operational risks referenced in the forward-looking statements section.