RegulatoryCompany release

Talphera asks FDA to let NEPHRO CRRT enrolment close early for nafamostat PMA

🇺🇸 Talphera, Inc. (TLPH) · Thu 12 Nov 2026

The company has sent the FDA a briefing document seeking agreement that the nafamostat study can close at the end of 2026 even if fewer than 70 patients are enrolled.

Talphera, Inc. said on 12 November 2026, alongside its third-quarter results, that it has submitted a briefing document to the US Food and Drug Administration (FDA) for a Sprint Meeting. The document asks whether enrolment in the NEPHRO CRRT study can close as of 31 December 2026, even if the planned 70 patients have not been reached.

The study is testing nafamostat, branded Niyad, a regional anticoagulant for use in continuous renal replacement therapy (CRRT). The data are intended to support a premarket approval (PMA) application.

Talphera reports that enrolment has passed 75% and that the study has more than 80% power for its primary endpoint. The company has also raised its peak sales estimate for the product to above $200 million.

On the financial side, Talphera reported cash and investments of $14.2 million at 30 September 2026. The summary available does not set out the FDA's response or a timetable for the Sprint Meeting.

What it means for your team

  • Regulatory teams should note that a smaller-than-planned sample size is being put to the FDA for agreement before enrolment closes, rather than after the fact.
  • The outcome of the Sprint Meeting will indicate how flexible the agency is on enrolment targets in device-pathway (PMA) studies of anticoagulants for CRRT.
  • Market-access teams may watch the company's raised peak sales estimate of above $200 million, which remains the company's own figure and depends on approval.

Company's press release (SEC filing): Talphera, Inc. ↗

Article written by VigiEye from the official source (Talphera, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →