Talphera Reports Third Quarter 2026 Financial Results and Provides Business Update
PR Newswire•12/11/2026•16:01 ET
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Key Highlights
- ➤NEPHRO study enrollment exceeds 75% of 70-patient target
- ➤NEPHRO study currently exceeds 80% power for primary endpoint
- ➤FDA briefing requests enrollment close based on patients enrolled by December 31, 2026
- ➤Nafamostat peak sales estimate raised above $200 million
- ➤Cash and investments totaled $14.2 million at September 30, 2026
Expert Statements
Vince Angotti, CEO of Talphera
“We believe nafamostat has the potential to address an important unmet need as a regional anticoagulant for critically ill patients undergoing CRRT”
Vince Angotti, CEO of Talphera
“Our updated market research, including physician feedback on nafamostat compared with currently used products, supports its potential adoption in CRRT and an increased peak sales estimate of more than $200 million.”
Vince Angotti, CEO of Talphera
“Enrollment in the NEPHRO CRRT study has slowed over recent months, primarily due to fewer qualifying patients at our clinical sites. Enrolling these critically ill patients is challenging and other recent CRRT studies having faced similar difficulties. Some sponsors closed enrollment early and subsequently received regulatory approval.”
Vince Angotti, CEO of Talphera
“To date, we have enrolled more than 75% of the planned 70 patients. To support our goal of completing the study this year, we have submitted a briefing document to the FDA seeking feedback on closing enrollment as of December 31, 2026, even if fewer than the targeted 70 patients are enrolled. While the study remains blinded and open for enrollment, we believe the current enrollment is sufficient to support a PMA filing as it has over 80% statistical power for the primary endpoint”
Talphera Reports Third Quarter 2026 Financial Results and Provides Business Update PR Newswire
Briefing document submitted to FDA for a Sprint Meeting requesting a close of the NEPHRO CRRT study enrollment based on number of patients enrolled as of December 31, 2026
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