Talphera Seeks FDA Nod to Stop Niyad Trial Short, Lifts Sales Outlook Above $200m

Talphera is betting that a faster route to filing will matter more than a full enrolment tally. Alongside its third-quarter results on 12 November 2026, the company said it has asked the US Food and Drug Administration to agree that recruitment into its pivotal nafamostat study can stop at the end of the year, even if the target of 70 patients is not met.

The request sits in a briefing document submitted for a Sprint Meeting with the agency. The study, known as NEPHRO CRRT, is examining nafamostat, branded Niyad, as a regional anticoagulant for continuous renal replacement therapy. Its results are meant to underpin a premarket approval (PMA) application, the route used for higher-risk devices.

Talphera says enrolment has already passed 75% and that the trial retains more than 80% power for its primary endpoint. The company has also lifted its peak sales estimate for the product to above $200 million. That is Talphera's own projection and depends on the product winning approval.

The balance sheet gives context for the timing. Talphera reported cash and investments of $14.2 million at 30 September 2026. The material available does not say how the FDA has responded, nor when the Sprint Meeting will take place.