Long-term TransCon PTH data from Ascendis Pharma (ASND) show sustained benefits

Rhea-AI Filing Summary

Ascendis Pharma A/S filed a report highlighting Week 182 results from its completed Phase 3 PaTHway Trial of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism. Over three and a half years, TransCon PTH showed sustained efficacy and safety, replicating the actions of natural parathyroid hormone across key organs, including the central nervous system, kidneys, small intestine, and bone.

The trial reported improved quality of life and normalized, stable measures such as urine calcium, serum calcium, serum phosphate, and bone mineral density. These benefits were maintained while allowing most patients to become independent from conventional therapy using active vitamin D and calcium supplements, based on predefined trial endpoints.

Insights

Biotech and clinical trial analyst

Ascendis reports sustained 3.5-year efficacy and safety for TransCon PTH in hypoparathyroidism.

Ascendis Pharma presents long-term Phase 3 PaTHway data showing TransCon PTH maintained efficacy and safety through Week 182 in adults with hypoparathyroidism. The therapy replicated endogenous parathyroid hormone actions across central nervous system, kidney, small intestine, and bone, with improvements in quality of life and key biochemical markers.

Endpoints covered independence from conventional therapy, normocalcemia, renal function via eGFR, bone mineral density by DXA, symptom assessments with HPES, and health-related quality of life with SF-36. Seventy-three of 82 enrolled adults completed the three-and-a-half-year trial, indicating strong long-term follow-up.

These data reinforce the durability profile of TransCon PTH after the randomized period and through the 156-week open-label extension. Future regulatory and commercialization outcomes will depend on how agencies and clinicians weigh these long-term efficacy, safety, and quality-of-life results alongside existing treatment options.

Key Figures

Patients enrolled: 82 adults Post-surgical cases: 85% Non-surgical cases: 15% +5 more

8 metrics

Patients enrolled 82 adults Adults with hypoparathyroidism in Phase 3 PaTHway Trial

Post-surgical cases 85% Proportion of trial patients with post-surgical hypoparathyroidism

Non-surgical cases 15% Proportion of trial patients with non-surgical hypoparathyroidism

Randomized controlled period 26 weeks Double-blind, placebo-controlled phase of PaTHway Trial

Open-label extension 156 weeks Duration of open-label extension through Week 182

Trial completion 73 of 82 (89%) Patients completing three-and-a-half-year PaTHway Trial

Normocalcemia range 8.3 to 10.6 mg/dL Serum calcium target range for maintaining normocalcemia

Calcium dose for independence <600 mg/day Threshold defining independence from conventional calcium therapy

Key Terms

TransCon PTH (palopegteriparatide), Phase 3 PaTHway Trial, hypoparathyroidism, open-label extension (OLE), +2 more

6 terms

TransCon PTH (palopegteriparatide) medical

"long-term treatment with TransCon PTH (palopegteriparatide) demonstrated sustained efficacy and safety"

Phase 3 PaTHway Trial medical

"Week 182 data from its completed Phase 3 PaTHway Trial showing that long-term treatment"

hypoparathyroidism medical

"sustained efficacy and safety in adults with hypoparathyroidism"

A disorder in which small glands in the neck fail to make enough of a hormone that keeps blood calcium at the right level, causing low calcium with symptoms such as muscle cramps, tingling or fatigue. For investors, it matters because chronic, hard-to-manage conditions like this create demand for medicines, medical devices and diagnostic tests, shaping clinical trial needs, regulatory review and potential market opportunity much like a persistent mechanical problem creates ongoing demand for repairs.

open-label extension (OLE) medical

"followed by a 156-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) medical

"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) medical

"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.

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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 13, 2026, the Company announced Week 182 data from its completed Phase 3 PaTHway Trial showing that long-term treatment with TransCon PTH (palopegteriparatide) demonstrated sustained efficacy and safety in adults with hypoparathyroidism. Over the three-and-a-half-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 – CNS, kidney, small intestine, and bone – as demonstrated by improved quality of life and normalized and stable urine calcium, serum calcium, serum phosphate, and bone mineral density. These benefits were sustained while enabling independence from conventional therapy with active vitamin D and calcium.

Highlights of Week 182 Results from the Phase 3 PaTHway Trial

• 86% 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.

• 89% of patients had normal albumin-adjusted serum calcium levels and a mean value of 8.8 mg/dL.

• 100% of patients achieved independence from active vitamin D, defined as not taking calcitriol or alfacalcidol.

• 96% 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 80.2 (1.8) mL/min/1.73 m² at Week 182, reflecting a mean (SE) increase of 11.0 (1.4) mL/min/1.73 m² from baseline. Among patients randomized to TransCon PTH, eGFR increased from baseline through Week 38 and stabilized thereafter. After initiation of open-label treatment at Week 26, patients who had been receiving placebo in the double-blind period experienced a similar increase in eGFR. Following these eGFR increases, mean eGFR values were maintained through Week 182, in contrast to the expected typical age-related decline in eGFR in adults.¹

• Mean 24-hour urine calcium decreased substantially, normalized within 26 weeks, and remained normal through Week 182.

• 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 182.

• As measured by SF-36, all subscale scores and component summary scores demonstrated rapid and clinically meaningful improvements with TransCon PTH treatment which were sustained through Week 182.

• Mean BMD Z-scores (matched for age and sex) corrected from high baseline levels through Week 26 and remained above 0 through Week 182.

• 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.

• Over three and a half years of treatment, no patients developed anti-PTH antibodies.

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

The PaTHway Trial of 82 adults with hypoparathyroidism (85% post-surgical, 15% non-surgical) included a 26-week randomized, double-blind, placebo-controlled period followed by a 156-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. Seventy-three of the original 82 patients enrolled (89%) completed the three-and-a-half-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 182. 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 15, 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 6-K?

Ascendis Pharma reported Week 182 data from its completed Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism, highlighting sustained efficacy, safety, improved quality of life, and normalized biochemical markers over three and a half years of treatment.

What is TransCon PTH in the Ascendis Pharma (ASND) trial?

TransCon PTH (palopegteriparatide) is Ascendis Pharma’s investigational therapy designed to replicate endogenous parathyroid hormone actions. In the Phase 3 PaTHway Trial, it showed sustained efficacy, safety, and organ-level benefits for adults living with chronic hypoparathyroidism over long-term treatment.

How long did the Ascendis Pharma PaTHway Trial for TransCon PTH run?

The PaTHway Trial followed adults with hypoparathyroidism for three and a half years. It included a 26-week randomized, double-blind, placebo-controlled period and a 156-week open-label extension, with Week 182 representing the final assessment of long-term outcomes.

How many patients completed Ascendis Pharma’s Phase 3 PaTHway Trial?

The PaTHway Trial enrolled 82 adults with hypoparathyroidism, and 73 patients, or 89%, completed the three-and-a-half-year study. This high completion rate supports the feasibility of long-term TransCon PTH treatment in this chronic endocrine condition.

What key outcomes improved in Ascendis Pharma’s PaTHway Trial?

Key outcomes included improved quality of life, normalized and stable urine calcium, serum calcium, serum phosphate, and bone mineral density. The trial also demonstrated that patients could achieve independence from conventional therapy with active vitamin D and high-dose calcium supplements.

How was quality of life measured in Ascendis Pharma’s PaTHway Trial?

Quality of life in the PaTHway Trial was evaluated using the 36-Item Short Form Survey (SF-36 version 2) and the Hypoparathyroidism Patient Experience Scale (HPES), capturing both health-related quality of life and disease-specific symptoms and functional impacts over 182 weeks.