Talphera Inc - Company Profile
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Business Description
Talphera Inc (Talphera), formerly AcelRx Pharmaceuticals Inc, is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.
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R&D Overview
Talphera is committed to advancing its research and development efforts to bring innovative therapies to medically supervised environments. The company's R&D strategy is primarily focused on the development and commercialization of its lead product candidate, Niyad, and exploring the broader applications of nafamostat. Niyad is a lyophilized formulation of nafamostat designed for use as a regional anticoagulant in dialysis circuits and is currently undergoing a registrational trial under an Investigational Device Exemption (IDE). It has received Breakthrough Device Designation from the FDA. The primary focus is to establish Niyad as the first FDA-approved regional anticoagulant for continuous renal replacement therapy (CRRT) in acute kidney injury patients, with potential use in chronic kidney disease patients undergoing intermittent hemodialysis. Additionally, Talphera is developing LTX-608, another nafamostat formulation intended for direct IV infusion, evaluating its potential for treating conditions such as disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), acute pancreatitis, and as an antiviral treatment. The company plans to submit an Investigational New Drug (IND) application following toxicology evaluations to enable Phase 2 studies. Talphera has also been exploring pre-filled syringe product candidates, including Fedsyra and PFS-02. The R&D unit of Talphera is responsible for the development and commercialization of its lead product candidate, Niyad, and exploring the broader applications of nafamostat. The unit manages the company's R&D activities, including the development of LTX-608 and the evaluation of pre-filled syringe product candidates. In FY2025, the company invested US$6 million in its R&D activities.
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