Talphera, Inc. (Nasdaq: TLPH) announced on November 12, 2026, that it has submitted a briefing document to the U.S. Food and Drug Administration (FDA) requesting feedback on closing the enrollment of its NEPHRO CRRT clinical study as of December 31, 2026. The company stated that the study, which is designed to enroll 70 adult patients, has currently enrolled more than 75% of the target. Talphera noted that enrollment has slowed due to the difficulty of recruiting critically ill patients but believes the current enrollment provides over 80% statistical power for the primary endpoint, which is the mean post-filter activated clotting time over the first 24 hours.
The company also reported an update on its commercial prospects. Based on new market research, Talphera raised its estimated peak sales for nafamostat in continuous renal replacement therapy (CRRT) to more than $200 million. The drug is being developed as Niyad, a lyophilized formulation of nafamostat, which has received Breakthrough Device Designation from the FDA.
Regarding its financial position, Talphera reported cash and investments of $14.2 million as of September 30, 2026. For the third quarter of 2026, the company reported a net loss of $4.0 million, or $0.05 per share, compared to a net loss of $4.4 million, or $0.11 per share, for the same period in 2025. The company plans to file a Form S-3 Shelf Registration Statement to replace its existing registration that expires on November 30, 2026.
