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Pathalys Pharma Announces Late-Breaking Abstract from Pivotal Phase 3 Program Selected as Featured Oral Presentation at ASN Kidney Week 2026

Pathalys Pharma

Pathalys Pharma Announces Late-Breaking Abstract from Pivotal Phase 3 Program Selected as Featured Oral Presentation at ASN Kidney Week 2026

PR Newswire

RALEIGH, N.C., Oct. 5, 2026

~ Results from two Phase 3 studies, which evaluated upacicalcet in the treatment of patients with secondary hyperparathyroidism (SHPT) with end-stage kidney disease receiving hemodialysis, will be presented

SHPT is a common complication of chronic kidney disease (CKD), affecting nearly all patients with kidney failure receiving maintenance dialysis ~

RALEIGH, N.C., Oct. 5, 2026 /PRNewswire/ — Pathalys Pharma, Inc., a private, US-based biopharmaceutical company committed to supporting the unique needs of patients with chronic kidney disease (CKD), announced today that data from the company’s Phase 3 program for upacicalcet will be delivered as a featured late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, CO, being held October 21-25, 2026. In addition, an informational poster will describe biomarker results from the trials.

Pathalys is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of late stage chronic kidney disease (CKD).

The safety and efficacy of upacicalcet were evaluated in PATH-1 (NCT05832931) and PATH-2 (NCT05836220), two Phase 3, randomized, double-blind, placebo-controlled studies, in the treatment of patients with secondary hyperparathyroidism (SHPT) with end-stage kidney disease receiving hemodialysis. Both trials included open-label extensions.1,2

“Secondary hyperparathyroidism (SHPT) remains a significant and common complication of chronic kidney disease (CKD), affecting nearly all patients who receive maintenance dialysis due to kidney failure. Despite advances in treatment, important gaps remain in the management of this challenging condition,” said Neal Fowler, Chief Executive Officer of Pathalys Pharma. “At Pathalys, addressing these gaps is more than an ambition – it is our call to action. Presenting the findings from our Phase 3 program during Kidney Week represents an important milestone in our commitment to bringing innovation to patients and the healthcare professionals who care for them.”

Oral Presentation Details:

Efficacy and Safety of Upacicalcet in Patients with Secondary Hyperparathyroidism (SHPT) on Hemodialysis: Two Randomized Controlled Clinical Trials (RCTs):

  • Session Title: Late-Breaking Research Orals: AKI, CKD, CKM, and More
  • Presenting Author: Jessica B. Kendrick, MD, MPH
  • Session Date/Time: October 23, 2026 from 4:30 – 6:00 PM MDT
  • Session Room: Four Seasons Ballroom 2 (Convention Center)
  • Abstract Publication #: FR-OR112

Poster Presentation Details:

CKD-MBD Biomarker Profile in Patients on Hemodialysis with Secondary Hyperparathyroidism Treated with Upacicalcet: Biomarker Results from the Phase 3 PATH-1 and PATH-2 Trials

  • Session Title: CKD-MBD: Mechanistic Insights and Management [PO0502-1]
  • Presenting Author: Thomas L. Nickolas, MD, MS
  • Session Date/Time: October 23, 2026 from 10:00 AM – 12:00 PM MDT
  • Session Room: Exhibit Hall A, Convention Center
  • Poster #: FR-PO0299

Upacicalcet is an investigational product candidate in the United States and has not been approved by the U.S. Food and Drug Administration (FDA).

About Pathalys
Pathalys is a private, U.S.-based biopharmaceutical company committed to supporting the unique needs of patients living with chronic kidney disease (CKD). An initial area of focus is pursuing advancements in the treatment of secondary hyperparathyroidism (SHPT), a common complication for the approximately 486,000 patients in the U.S. with CKD undergoing hemodialysis each year.3

SHPT develops as the body struggles to maintain healthy calcium, phosphorus and parathyroid hormone levels when kidney function is lost.4 Pathalys is developing upacicalcet, an investigational small molecule calcimimetic for the treatment of SHPT.

Founded in 2021, Pathalys was built to be a U.S.-based biopharmaceutical company focused on innovation to meet the needs of patients living with CKD.

Learn more at PATHALYS.com and follow us on LinkedIn.

1 Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1 (PATH-1). ClinicalTrials.gov. Accessed August 12, 2026. https://clinicaltrials.gov/study/NCT05832931.
2 Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2 (PATH-2). ClinicalTrials.gov. Accessed August 12, 2026. https://clinicaltrials.gov/study/NCT05836220
3 USRDS 2025 Annual Data Report. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed August 26, 2026. https://usrds-adr.niddk.nih.gov/2025.
4 National Kidney Foundation. Kidney Topics. SHPT. https://www.kidney.org/kidney-topics/secondary-hyperparathyroidism-shpt. Last accessed Sept. 17, 2026

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SOURCE Pathalys Pharma

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