Talphera
TLPHTLPH · Stock Price
Historical price data
Overview
Talphera is a publicly traded biopharma focused on developing and commercializing innovative therapies for medically supervised settings, having transformed from AcelRx Pharmaceuticals in 2023. Its core strategy revolves around nafamostat mesylate, a molecule with anticoagulant, anti-inflammatory, and antiviral properties, initially targeting anticoagulation during dialysis with its lead candidate Niyad™. With Niyad's Phase 3 data expected by end of 2025 and a pipeline of follow-on nafamostat indications and hospital-ready prefilled syringes, Talphera aims to address significant gaps in hospital-based care. The company's approach is validated by nafamostat's decades of use in Asia and a strategic partnership with Laboratoire Aguettant.
Technology Platform
A 'pipeline-in-a-product' strategy centered on nafamostat mesylate, a broad-spectrum serine protease inhibitor with an 8-minute half-life, developed for multiple indications across device and drug regulatory pathways.
Pipeline
17| Drug | Indication | Stage | Watch |
|---|---|---|---|
| sufentanil sublingual tablet 30 mcg | Acute Moderate-to-severe Pain | Phase 3 | |
| Sufentanil NanoTab PCA System/15 mcg + morphine IV PCA | Post-Operative Pain | Phase 3 | |
| Zalviso™ 15 mcg | Moderate-to-severe Acute Pain | Phase 3 | |
| Sufentanil NanoTab PCA System/15 mcg + Placebo Sufentanil Na... | Post-Operative Pain | Phase 3 | |
| sufentanil sublingual 30 mcg tablet | Moderate-to-severe Acute Pain | Phase 3 |
Opportunities
Risk Factors
Competitive Landscape
Niyad's primary competitors are regional citrate anticoagulation (complex to manage) and heparin (contraindicated in target population). Its ultrashort half-life and historical safety data provide differentiation. In prefilled syringes, it competes on convenience and safety against generic vials.
