Talphera reports NEPHRO CRRT trial 75% enrolled, KDIGO 2026 draft guideline backs nafamostat

Talphera, Inc. said its registrational NEPHRO CRRT study of nafamostat, formulated as Niyad, reached 75% enrollment and is expected to be completed this year.¹ CEO Vince Angotti said site realignment is complete, with all target clinical sites now activated.¹

The company also pointed to a regulatory development it called favorable. The KDIGO 2026 Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) is currently pending final publication following the close of its public comment period in May, and it references nafamostat as an acceptable regional anticoagulant during CRRT.¹ Talphera said this is a positive change from KDIGO's last published AKI guidelines.¹

Separately, Talphera cited updated market research. It said approximately 200,000 CRRT procedures will be performed in 2027 in the U.S., an increase of 21% over its prior estimate.¹ The company said it plans to host an investor event as it nears completion of enrollment, to share these findings and discuss the commercial opportunity for nafamostat, if approved, including the potential favorable implications of the evolving KDIGO guidelines.¹

Talphera also disclosed it regained Nasdaq compliance with the $1 bid price rule.¹

On finances, the company reported a cash and investments balance of $17.1 million as of June 30, 2026.¹ Combined R&D and SG&A expenses totaled $3.9 million in the second quarter of 2026 compared to $3.7 million a year earlier, an increase the company attributed primarily to higher Niyad development expenses reflecting increased enrollment.¹ Net loss attributable to common shareholders was $4.3 million, or $0.06 per basic and diluted share, compared to a net loss of $3.5 million, or $0.10 per share, in the second quarter of 2025.¹