Talphera, Inc. $TLPH

What the company doesAI summary of filing

Talphera is a specialty pharmaceutical company developing therapies for use in medically supervised settings. The company's lead product candidate is Niyad (nafamostat mesylate), a lyophilized vial formulation in clinical development as a regional anticoagulant for continuous renal replacement therapy, which has received FDA Breakthrough Device Designation and is in a registrational trial expected to complete in 2026. The company also is developing LTX-608, a nafamostat formulation for direct intravenous infusion for potential indications including disseminated intravascular coagulation, acute respiratory distress syndrome, and acute pancreatitis, with an IND expected to be submitted following toxicology evaluation. Talphera is pre-revenue from its lead program and generates no revenue from its product candidates, though it divested the previously commercialized product DSUVIA in 2023. [10-K 2026-03-23]

Segments: Niyad (nafamostat mesylate) – regional anticoagulant for CRRT, LTX-608 (nafamostat for IV infusion) – for DIC, ARDS, acute pancreatitis, antiviral, Pre-filled syringe candidates (Fedsyra, Phenylephrine) – under evaluation for discontinuation