Ascendis Pharma (ASND) reports new TransCon CNP achondroplasia trial data

Rhea-AI Filing Summary

Ascendis Pharma A/S reports clinical and program updates across its achondroplasia franchise. In the Phase 2 open-label COACH trial, once-weekly combination therapy with TransCon CNP (100 µg/kg/week) and TransCon hGH (0.30 mg/kg/week) in children with achondroplasia continued to show durable growth, with mean annualized growth velocity at or above the 97th percentile of children of average stature at Week 78, while maintaining safety and tolerability.

The COACH trial includes 12 TransCon CNP–naïve children (mean age 5.26 years) and 9 previously treated children (mean age 8.32 years) who had received TransCon CNP monotherapy for a mean of 2.56 years. Across completed and ongoing trials, TransCon CNP monotherapy demonstrated durable height gains, additional benefits beyond height, and a safety profile similar to placebo with low injection site reactions. Ascendis also references U.S. launch progress for YUVIWEL (navepegritide) through June 30, 2026, and outlines forward-looking plans and risks related to regulatory filings, key trials, commercialization, funding, and broader operational uncertainties.

Filing Explained

This Form 6-K furnishes interim material information and is incorporated by reference into Ascendis’s specified Form S-8 and Form F-3 registration statements, making the report part of those filings from August 6, 2026, unless later reports supersede it.

Key Figures

Combination TransCon CNP dose: 100 µg/kg/week Combination TransCon hGH dose: 0.30 mg/kg/week COACH naïve cohort size: 12 children +5 more

8 metrics

Combination TransCon CNP dose 100 µg/kg/week Dose of TransCon CNP used once weekly in COACH Phase 2 trial

Combination TransCon hGH dose 0.30 mg/kg/week Starting weekly dose of TransCon hGH in COACH trial combination therapy

COACH naïve cohort size 12 children Number of TransCon CNP–naïve children enrolled in the COACH trial

COACH previously treated cohort size 9 children Number of previously TransCon CNP–treated children in the COACH trial

Prior monotherapy duration 2.56 years Mean prior TransCon CNP treatment duration in previously treated cohort

Mean age naïve cohort 5.26 years Mean age of TransCon CNP–naïve children at enrollment in COACH

Mean age previously treated cohort 8.32 years Mean age of previously TransCon CNP–treated children in COACH

Growth velocity benchmark 97th percentile Mean annualized growth velocity at or above this percentile at Week 78

Key Terms

achondroplasia, TransCon CNP, TransCon hGH, Phase 2 open-label trial, +2 more

6 terms

achondroplasia medical

"Treatment with the combination ... 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.

TransCon CNP medical

"combined treatment with once-weekly TransCon CNP at 100 µg/kg/week"

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.

TransCon hGH medical

"combined treatment with once-weekly TransCon CNP ... and once-weekly TransCon hGH"

Phase 2 open-label trial medical

"COACH is an ongoing prospective Phase 2 open-label trial"

Marketing Authorisation Application regulatory

"timing of a regulatory decision for the Marketing Authorisation Application"

A marketing authorisation application is the formal package a drug or medical-device maker submits to a health regulator to get permission to sell a product. Think of it as an application for a sales license: regulators review safety, effectiveness and manufacturing quality before granting permission. Investors watch these submissions because approval unlocks revenue and reduces development risk, while rejection or delays can materially affect a company’s value and timeline.

forward-looking statements financial

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

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.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What did Ascendis Pharma (ASND) report about its COACH achondroplasia trial?

Ascendis reported that in the Phase 2 COACH trial, combination therapy with TransCon CNP and TransCon hGH delivered durable growth, with mean annualized growth velocity at or above the 97th percentile at Week 78, while maintaining safety and tolerability in children with achondroplasia.

How is the COACH trial for Ascendis Pharma (ASND) designed?

COACH is a prospective Phase 2 open-label trial evaluating once-weekly TransCon CNP and TransCon hGH combination therapy in children with achondroplasia aged 2 to 11 years, including 12 treatment-naïve and 9 previously TransCon CNP–treated participants who had prior exposure averaging 2.56 years.

What did Ascendis Pharma (ASND) say about TransCon CNP monotherapy?

Across completed and ongoing trials, TransCon CNP monotherapy showed durable improvements in height, benefits beyond height, and a safety and tolerability profile similar to placebo, with a low rate of injection site reactions consistent with the incidence reported in the FDA label.

What commercialization update did Ascendis Pharma (ASND) provide on YUVIWEL?

Ascendis referenced a U.S. launch update for YUVIWEL (navepegritide, developed as TransCon CNP) through June 30, 2026, in the context of its broader commercialization activities and efforts to provide patient access, though specific launch metrics were not detailed in this summary.

Which forward-looking plans and risks did Ascendis Pharma (ASND) highlight?

Ascendis highlighted forward-looking plans for regulatory filings in infants, an expected Marketing Authorisation Application decision for TransCon CNP monotherapy, ongoing teACH, reACHin, and AttaCH trials, commercialization of YUVIWEL, and numerous risks including regulatory, clinical, manufacturing, market, funding, and geopolitical uncertainties.

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 August, 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 August 6, 2026, the Company provided updates across its achondroplasia programs.

Combination Therapy Update

(TransCon CNP + TransCon hGH; navepegritide + lonapegsomatropin)

Treatment with the combination of once-weekly TransCon CNP and once-weekly TransCon hGH continued to demonstrate durable growth in children with achondroplasia, with a mean annualized growth velocity (AGV) meeting or exceeding the 97^th percentile of children of average stature, without compromising safety or tolerability at Week 78.

Highlights of the Topline Week 78 COACH Trial Results

• Consistent with Week 26 and Week 52 results, mean AGV for children treated with combination therapy through Week 78 remained at or above the 97^th percentile AGV of children of average stature, with changes over time following age-related growth patterns, and sustained increases in ACH-specific height Z-score, indicating a tripling of efficacy compared to TransCon CNP monotherapy.

• For the TransCon CNP treatment-naïve cohort, mean AGV at Week 78 was 7.73 cm/year, with an increase in mean ACH-specific height Z-score of +1.29, increasing from 0.46 to 1.75 over 78 weeks.

• For the TransCon CNP-experienced cohort (mean treatment duration with TransCon CNP of 2.56 years), mean AGV at Week 78 was 7.67 cm/year, with an improvement in mean ACH-specific height Z-score of +1.10, increasing from 1.28 to 2.38 over 78 weeks.

• Children treated with combination therapy demonstrated continued improvements in body proportionality through Week 78, aligning with the increase in linear growth.

• Safety and tolerability were consistent with those observed for TransCon CNP and TransCon hGH monotherapies. Combination therapy was generally well-tolerated, with a low incidence of injection site reactions and generally mild treatment-emergent adverse events (TEAEs).

• To date, 100% of the 21 enrolled children completed 78 weeks of treatment and remain on therapy in the COACH Trial.

• Additional data from Week 78 of COACH to be presented at an upcoming medical meeting.

COACH Trial Design

COACH is an ongoing prospective Phase 2 open-label trial to investigate the efficacy, safety, and tolerability of combined treatment with once-weekly TransCon CNP at 100 µg/kg/week and once-weekly TransCon hGH at a starting dose of 0.30 mg/kg/week (“combination therapy”) in children with achondroplasia aged 2 to 11 years. The trial included a cohort of TransCon CNP treatment-naïve children (N=12, mean age 5.26 years) and a cohort of previously TransCon CNP-treated children (N=9, mean age 8.32 years), who had received TransCon CNP (100 µg/kg/week) for a mean of 2.56 years in clinical trials. The trial population is representative of children with achondroplasia and the prior treatment benefits of TransCon CNP monotherapy.

Monotherapy Update

(TransCon CNP; navepegritide)

In completed and ongoing clinical trials of children with achondroplasia, treatment with once-weekly TransCon CNP monotherapy demonstrated durable improvements in height, as well as benefits beyond height, and a safety and tolerability profile similar to placebo, including a low rate of injection site reactions, consistent with the incidence rate reported in the FDA label.

• Week 104 data from the pivotal ApproaCH Trial of TransCon CNP at 100 µg/kg once-weekly in children with achondroplasia aged 2 to 11 years demonstrated:

• Durable improvements in height as measured by annualized growth velocity (AGV) and height Z-scores over 104 weeks for those randomized to TransCon CNP, and significant improvement for those switching from placebo to TransCon CNP at Week 52.

• Benefits beyond height with TransCon CNP monotherapy, including improvements in lower limb alignment and body proportionality, as demonstrated by improved tibial-femoral angle and upper-to-lower body segment ratio, respectively, with durable treatment effect over 104 weeks for those randomized to TransCon CNP, and substantial improvement at Week 104 for those switching from placebo to TransCon CNP at Week 52.

• Through two years of treatment, TransCon CNP was generally well-tolerated. Most adverse events in TransCon CNP-treated children were mild or moderate, with none leading to treatment discontinuation or withdrawal from the trial. There were no occurrences of symptomatic hypotension, and the overall rate of injection-site reactions, all of which were mild, was 0.35 per person-year of exposure.

• Completed target enrollment for pivotal reACHin Trial, supporting planned regulatory filings for infants 0 to <2 years of age with achondroplasia.

• To date, 96% of the 140 children enrolled in the AttaCH long-term open-label extension trial remain on TransCon CNP monotherapy, with up to nearly 6 years of treatment, or are in the ongoing COACH combination therapy trial.

• The AttaCH Trial, following children to near-final adult height, continues to enroll children who complete TransCon CNP monotherapy trials (ACcomplisH, ApproaCH, teACH, and reACHin).

• The ongoing pivotal reACHin Trial is evaluating the safety, tolerability, and efficacy of TransCon CNP in infants with achondroplasia (aged 0 to <2 years).

• The ongoing pivotal teACH Trial is evaluating the safety, tolerability, and efficacy of TransCon CNP in adolescents with achondroplasia (aged 12 to <18 years).

• In the European Union, a decision is anticipated in the fourth quarter of 2026 for the Marketing Authorisation Application for TransCon CNP as a monotherapy for children with achondroplasia.

YUVIWEL U.S. Launch Update through June 30, 2026

(navepegritide; developed as TransCon CNP)

• More than 170 unique patient enrollments by approximately 90 prescribing healthcare providers, with more than 65% approved for reimbursement, through June 30, 2026.

• All enrollments through this date reflect patients new to YUVIWEL therapy.

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 (i) planned regulatory filings for infants 0 to <2 years of age with achondroplasia, (ii) the anticipated timing of a regulatory decision for the Marketing Authorisation Application for TransCon CNP as a monotherapy for children with achondroplasia, (iii) the potential benefits of TransCon CNP monotherapy and combination therapy with TransCon hGH, (iv) Ascendis’ clinical development activities, including the teACH, reACHin, and AttaCH trials, (v) Ascendis’ commercialization activities and efforts to provide access to YUVIWEL, and (vi) Ascendis’ ability to apply its TransCon technology platform to develop new therapies with best-in-class potential. 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: August 6, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer