Talphera Makes Strategic Moves with FDA and Financing for NEPHRO CRRT Study

Talphera's Progress: Partnership with FDA and New Financing



Talphera, Inc., a California-based specialty pharmaceutical company, has made notable strides in its clinical research efforts by collaborating with the U.S. Food and Drug Administration (FDA). The company has received approval to cut the number of participants in its NEPHRO CRRT study from 166 to just 70 patients. This adjustment is expected to streamline the study's focus while maintaining a robust 90% statistical power for its primary endpoints.

As part of this new strategy, Talphera plans to conclude the NEPHRO CRRT study by the end of 2025. Currently, six patients are already enrolled in the trial, which investigates the efficacy of its lead product candidate, Niyad™, a formulation of nafamostat designed for use in critical care settings.

Financial Backing and Future Prospects


In conjunction with this FDA agreement, Talphera has announced a substantial private placement financing initiative led by Nantahala Capital and Rosalind Advisors. The financing aims to generate gross proceeds of up to $14.8 million, structured in three tranches. The first tranche is set to close shortly, with anticipated gross proceeds of approximately $4.925 million. The subsequent tranches are contingent upon achieving specific patient enrollment milestones.

CEO Vince Angotti expressed enthusiasm about this latest development:
“We are pleased that the FDA agreed with our assessment to reduce the study size to 70 patients, which still keeps the study's primary endpoint powered at 90%. This change will support a timely completion of the study, which we aim to finalize by the year’s end.”


Angotti further emphasized the vital role that ongoing financial support plays in achieving their clinical objectives, particularly as they aim to submit a Pre-Market Approval (PMA) application early next year, with hopes for approval in the latter half of 2026.

Study Parameters


The NEPHRO CRRT study is modeled as a prospective, double-blind trial conducted across up to 14 intensive care units in the United States. It aims to evaluate 70 adult patients who require renal replacement therapy but cannot tolerate heparin due to bleeding risks. Key metrics under review include mean post-filter activated clotting time and several secondary endpoints related to filter lifespan and dialysis efficacy.

Given the existing cash reserves reported at a robust $8.9 million as of December 31, 2024, combined with the projected financing, Talphera is poised to sustain operations smoothly through the anticipated completion of the study.

An Innovative Approach to Patient Care


Talphera's innovative approach with Niyad™ reflects the company’s commitment to addressing critical patient needs in medically supervised environments. The formulation of nafamostat, renowned for its broad-spectrum anticoagulant properties, is underscored by its Breakthrough Device Designation status by the FDA, indicating a promising avenue in the treatment of conditions requiring anticoagulation.

As Talphera navigates this essential stage in its clinical development, the focus remains steadfast on ensuring a successful study completion, thereby advancing the potential for Niyad™ to deliver effective patient outcomes in future therapeutic interventions. The collaboration with investors underscores the confidence in Talphera's vision and the critical importance of accessible and innovative medical treatments in healthcare today.

In summary, Talphera, Inc. is on a promising trajectory with its NEPHRO CRRT study and financial backing, potentially redefining treatment standards in renal care while navigating toward regulatory milestones that could ultimately benefit a broader patient population.

Topics Health)

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