Five-year TransCon PTH trial results reported by Ascendis Pharma (ASND)

Rhea-AI Filing Summary

Ascendis Pharma A/S reported 5-year (Week 266) results from its Phase 2 PaTH Forward Trial of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism. The company states long-term treatment showed sustained efficacy and safety while replicating key systemic actions of natural parathyroid hormone.

The 59-patient trial, mostly post-surgical cases, followed a 4-week randomized, double-blind, placebo-controlled period with a 262-week open-label extension. Ascendis reports that TransCon PTH maintained normalized and stable urine calcium, serum calcium, quality of life, and bone mineral density, enabling independence from conventional active vitamin D and calcium therapy.

Additional measures included renal function by estimated glomerular filtration rate, bone mineral density by DXA, symptom burden via the Hypoparathyroidism Patient Experience Scale, and broader health-related quality of life using the SF-36 survey, alongside safety monitoring of treatment-emergent adverse events and 24-hour urine calcium.

Insights

Biopharma clinical development analyst

Ascendis highlights 5-year Phase 2 durability data for TransCon PTH in hypoparathyroidism.

Ascendis Pharma reports that TransCon PTH maintained stable biochemical control, bone health, and quality-of-life metrics over 5 years in adults with hypoparathyroidism. The design used an initial 4-week randomized period followed by a long (262-week) open-label extension.

The company notes high retention, with 56 of 59 patients completing the full trial, and describes patients becoming independent from conventional calcium and active vitamin D while remaining normocalcemic. Renal function by eGFR, bone mineral density by DXA, and symptom measures were tracked alongside safety signals.

As Phase 2 data in a relatively small cohort, these results mainly address durability and safety over time rather than registration-level evidence. Future regulatory or Phase 3 outcomes are not described here, so the long-term commercial and approval implications are not defined in this excerpt.

Key Figures

Trial duration: 5 years (Week 266) Patients enrolled: 59 adults Completion rate: 56 of 59 patients +4 more

7 metrics

Trial duration 5 years (Week 266) Length of Phase 2 PaTH Forward Trial

Patients enrolled 59 adults Adults with hypoparathyroidism in PaTH Forward Trial

Completion rate 56 of 59 patients Patients completing five-year trial (95%)

Trial design periods 4-week + 262-week Randomized period plus open-label extension

Post-surgical share 80% Portion of trial patients with post-surgical hypoparathyroidism

Non-surgical share 20% Portion of trial patients with non-surgical hypoparathyroidism

Normocalcemia range 8.3 to 10.6 mg/dL Serum calcium range used to define normocalcemia

Key Terms

Phase 2 PaTH Forward Trial, open-label extension (OLE), estimated glomerular filtration rate (eGFR), Bone mineral density (BMD), +2 more

6 terms

Phase 2 PaTH Forward Trial financial

"Highlights of Week 266 Results from the Phase 2 PaTH Forward Trial"

open-label extension (OLE) financial

"followed by a 262-week open-label extension (OLE) period"

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.

estimated glomerular filtration rate (eGFR) financial

"Renal function was assessed by estimated glomerular filtration rate (eGFR)."

Estimated glomerular filtration rate (eGFR) is a test that measures how well your kidneys are filtering waste from your blood. It helps doctors check kidney health and detect problems early, much like how a water filter's effectiveness can be tested by how clean the water becomes.

Bone mineral density (BMD) financial

"Bone mineral density (BMD) measured by DXA scan was assessed at baseline"

Bone mineral density (BMD) measures the amount of mineral—mainly calcium—contained in a section of bone and is used as a proxy for bone strength and fracture risk. Investors care because BMD results drive demand for drugs, diagnostics, imaging equipment and medical services for osteoporosis and other bone diseases; think of it like measuring the thickness of a pipe wall to judge whether it will hold up under stress, which affects market size and regulatory approval.

Hypoparathyroidism-related symptoms financial

"Hypoparathyroidism-related symptoms and functional impacts were measured using the HPES."

Health-related quality of life financial

"Health-related quality of life was measured using the 36-Item Short Form Survey"

A measure of how a person’s health status affects their ability to live, work and enjoy life, covering physical comfort, mental well‑being and social participation, usually captured by patient questionnaires and numeric scores. Investors care because improvements in these scores can drive regulatory approval, insurance coverage, patient demand and pricing, much like customer satisfaction ratings predict whether a product will sell and generate revenue.

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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 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 11, 2026, the Company announced 5-year (Week 266) data from its Phase 2 PaTH Forward Trial showing that long-term treatment with TransCon PTH (palopegteriparatide) demonstrated sustained efficacy and safety in adults with hypoparathyroidism. Over the five-year duration of the trial, TransCon PTH replicated the systemic actions of endogenous PTH, with a balanced, beneficial impact on the main target organ systems – kidney, small intestine, CNS, and bone – as demonstrated by normalized and stable urine calcium, serum calcium, quality of life, and bone mineral density. These benefits were sustained while enabling independence from conventional therapy with active vitamin D and calcium.

Highlights of Week 266 Results from the Phase 2 PaTH Forward Trial

• 82% of patients were responders for the multi-component endpoint of (1) serum calcium in the normal range, (2) taking no active vitamin D, and (3) taking <600 mg/day of calcium.

• 88% of patients had normal albumin-adjusted serum calcium levels, with a mean value of 9.0 mg/dL.

• 96% of patients achieved independence from active vitamin D, defined as not taking calcitriol or alfacalcidol.

• 95% of patients achieved independence from therapeutic doses of calcium, defined as taking <600 mg/day of calcium.

• Significant improvements in kidney function were maintained, with mean (SE) eGFR of 78.0 (3.0) mL/min/1.73 m2 at Week 266, reflecting a mean (SE) increase of 9.4 (1.9) mL/min/1.73 m2 from baseline. Improvements were evident as early as Week 4, increased through Week 58, and were sustained over five years of treatment, in contrast to the expected normal age-related decline in eGFR in adults.¹

• Mean 24-hour urine calcium decreased substantially, normalized within 26 weeks, and remained normal through Week 266.

• As measured by Hypoparathyroidism Patient Experience Scales (HPES), patients reported improvements in symptoms and health-related quality of life across all domains. Hypoparathyroidism-related physical and cognitive symptoms and impacts on physical functioning and daily life improved rapidly with TransCon PTH treatment and were maintained through Week 266.

• As measured by SF-36, all mean health-related quality of life subscale and component summary scores rapidly normalized with TransCon PTH treatment and remained in the normative range through Week 266.

• Mean BMD Z-scores (matched for age and sex) corrected from high baseline levels through Week 26 and remained above 0 through Week 266.

• In the trial, TransCon PTH treatment was generally well-tolerated, with no new safety signals identified. Treatment-emergent adverse events (AEs) were mostly mild or moderate, and no discontinuations were related to study drug.

• One patient developed transient, low-titer and non-neutralizing anti-PTH antibodies, with no impact on safety or efficacy. Over five years of treatment, no other patients developed anti-PTH antibodies.

The PaTH Forward Trial of 59 adults with hypoparathyroidism (80% post-surgical, 20% non-surgical) included a 4-week randomized, double-blind, placebo-controlled period followed by a 262-week open-label extension (OLE) period, and measured a wide array of clinical, biochemical, and quality of life endpoints, consistent with the breadth of negative long-term impacts experienced by patients with hypoparathyroidism. Fifty-six of the original 59 patients

¹  Guppy M et al. BMJ Open. 2024;14(11):e089783. doi:10.1136/bmjopen-2024-089783

enrolled (95%) completed the five-year trial. Endpoints included independence from conventional therapy (defined as <600 mg/day of calcium and no active vitamin D) and maintenance of normocalcemia (8.3 to 10.6 mg/dL). Renal function was assessed by estimated glomerular filtration rate (eGFR). Bone mineral density (BMD) measured by DXA scan was assessed at baseline and regular intervals through Week 266. Hypoparathyroidism-related symptoms and functional impacts were measured using the HPES. Health-related quality of life was measured using the 36-Item Short Form Survey (SF-36 version 2). Safety assessments included treatment-emergent AEs and 24-hour urine calcium excretion.

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 12, 2026				By:		/s/ Michael Wolff Jensen
						Michael Wolff Jensen
						Executive Vice President, Chief Legal Officer

FAQ

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

Ascendis Pharma reported 5-year data from its Phase 2 PaTH Forward Trial of TransCon PTH in adults with hypoparathyroidism, highlighting sustained efficacy, safety, biochemical control, bone health, and quality-of-life outcomes over 266 weeks of treatment.

How long did Ascendis Pharma’s PaTH Forward Trial of TransCon PTH (ASND) run?

The PaTH Forward Trial followed patients for five years, through Week 266. It included a 4-week randomized, double-blind, placebo-controlled period, then a 262-week open-label extension, allowing Ascendis Pharma to assess long-term efficacy, safety, and patient-reported outcomes on TransCon PTH.

How many patients completed Ascendis Pharma’s PaTH Forward Trial for TransCon PTH?

Fifty-six of the original 59 adults with hypoparathyroidism completed the five-year trial. This 95% completion rate suggests strong long-term treatment adherence and allowed Ascendis Pharma to collect extensive longitudinal data on efficacy, safety, and quality-of-life measures for TransCon PTH.

What key benefits did TransCon PTH show in Ascendis Pharma’s 5-year data?

Ascendis Pharma states TransCon PTH maintained normalized and stable urine calcium, serum calcium, quality of life, and bone mineral density. Patients reportedly achieved independence from conventional active vitamin D and calcium therapy while the drug replicated systemic actions of endogenous parathyroid hormone across multiple organ systems.

What clinical endpoints were assessed in Ascendis Pharma’s PaTH Forward Trial?

Endpoints included independence from conventional therapy, maintenance of normocalcemia, renal function via estimated glomerular filtration rate, bone mineral density by DXA, hypoparathyroidism-related symptoms using the HPES, broader health-related quality of life with SF-36, and safety via treatment-emergent adverse events and 24-hour urine calcium.

What patient population was studied in Ascendis Pharma’s TransCon PTH Phase 2 trial?

The PaTH Forward Trial enrolled 59 adults with hypoparathyroidism, with 80% post-surgical and 20% non-surgical cases. This population reflects both surgery-related and other etiologies, allowing Ascendis Pharma to evaluate TransCon PTH’s long-term effects across typical clinical subgroups.