Talphera Inc Dossier
Qualitative Analysis
Business overview
Talphera, Inc. (formerly AcelRx Pharmaceuticals, Inc.) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. The company's lead product candidate is Niyad, a lyophilized formulation of nafamostat studied under an investigational device exemption (IDE) as a regional anticoagulant for the extracorporeal circuit in continuous renal replacement therapy (CRRT). Niyad has received Breakthrough Device Designation status from the FDA. Additionally, Talphera is developing pre-filled syringes in-licensed from Aguettant, including Fedsyra (ephedrine) and PFS-02 (phenylephrine).
Research as of 19 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Conducting the registrational clinical study for Niyad, a regional anticoagulant for Continuous Renal Replacement Therapy (CRRT).
Expected impact: Establish clinical efficacy and safety to support the PMA submission and subsequent FDA approval.
Evaluating market opportunities and preparing launch strategies for Niyad, including assessing whether to launch using internal resources or through a potential commercial partner.
Expected impact: Ensure rapid market adoption and establish Niyad as a new standard of care in the hospital acute care market upon regulatory approval.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Aligns Talphera with a strategic partner in the acute care space and provides capital to support the clinical development of Niyad.
Terms: $5 million equity investment at an at-market price of $0.55 per share, executed as part of a larger private placement of up to $29 million.