Talphera Advances Niyad for CRRT with Key Data Presentations at AKI & CRRT 2026 — Talphera, Inc.

Event summary

Talphera's two abstracts accepted for presentation at AKI & CRRT 2026 conference, March 29–April 2, 2026.
Posters detail NEPHRO-CRRT study design and preclinical data on nafamostat's pharmacokinetics in CRRT.
NEPHRO-CRRT study enrolling 70 patients across up to 14 U.S. ICUs, targeting FDA approval for nafamostat as first regional anticoagulant for CRRT.
Niyad (nafamostat formulation) has Breakthrough Device Designation from FDA and ICD-10 procedural code XY0YX37 issued.

The big picture

Talphera's progress with Niyad underscores the unmet need for safer anticoagulation in CRRT, a critical care setting where heparin alternatives are limited. The company's Breakthrough Device Designation and ICD-10 code issuance signal regulatory momentum, but success hinges on demonstrating efficacy in the ongoing registrational study. If approved, nafamostat could capture a niche in the $2B+ global CRRT market, particularly for patients at high bleeding risk.

What we're watching

Regulatory Pathway: Whether the NEPHRO-CRRT study results will support FDA approval of nafamostat as a regional anticoagulant for CRRT.
Clinical Execution: The pace at which Talphera enrolls patients in the NEPHRO-CRRT study and meets key endpoints.
Market Differentiation: How nafamostat's unique pharmacokinetic properties will position it against existing anticoagulants in CRRT.