Talphera Reaches 50% Enrollment in NEPHRO-CRRT Study for Acute Kidney Injury Treatment

Talphera Achieves Milestone in NEPHRO-CRRT Study Enrollment

Talphera, Inc. has reached a significant milestone in its NEPHRO-CRRT registrational study, successfully enrolling 35 out of the targeted 70 patients, which equates to 50% of the total enrollment goal. This progress follows major adaptations made in conjunction with the U.S. Food and Drug Administration (FDA) in 2025, which included a near 60% reduction in the overall patient enrollment number and an update in the criteria for inclusion. The company's recent focus on medical intensive care unit (ICU) sites, with nephrologists as principal investigators, has resulted in an impressive 90% patient enrollment rate from these newly targeted sites.

The pivotal NEPHRO-CRRT study aims to evaluate the safety and effectiveness of Talphera's novel approach for Continuous Renal Replacement Therapy (CRRT), which is critical for patients with acute kidney injury in medically supervised settings. Talphera's Chief Executive Officer, Vince Angotti, articulates optimism about completing the study within this year and expresses the company's ambition to file for Premarket Approval (PMA) with the FDA. This approval would enable Talphera to provide the only FDA-sanctioned regional anticoagulant specifically designed for CRRT—a need underscored by physician feedback highlighting the urgent requirement for better anticoagulant options in these scenarios.

With the clinical study progressing, Talphera is also gearing up for a virtual event scheduled for March 23, 2026, aimed at investors and analysts. This session will feature insights from renowned nephrologists, Dr. Blaithin McMahon and Dr. Joao Teixeira, who will discuss CRRT protocols and share their perspectives on current anticoagulant practices. The event promises valuable insights into the study's advancements, focusing on nafamostat, the drug being evaluated in the trial. Attendees will have the opportunity to engage in a Q&A session, facilitating a deeper understanding of both the ongoing research and the broader implications for treatment protocols in acute kidney injury.

As Talphera continues to drive its study forward, the company positions itself at the forefront of innovative therapies for renal therapies, addressing a gap in the market with potentially transformative solutions for critically ill patients. The progress made not only reflects Talphera's commitment to enhancing patient care through advanced pharmacotherapy but also emphasizes the collaborative effort required to navigate the complexities of clinical research in the regulatory environment. Overall, the developments signal a promising trajectory for Talphera as it strives to redefine CRRT anticoagulant practices.