Talphera
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 15
- Market Cap
- $16.4M
- Introduction
Talphera, Inc. engages in the development and commercialization of therapies used in medically supervised settings. The firm's portfolio includes DSUVIA, DZUVEO, Zalviso, ARX-02 and ARX-03. The company was founded by Thomas A. Schreck and Pamela Pierce Palmer on July 13, 2005 and is headquartered in San Mateo, CA.
Talphera's Niyad Receives FDA Agreement for Enrollment Acceleration in NEPHRO CRRT Trial
• Talphera has reached an agreement with the FDA for a Prior Approval Supplement (PAS) review to reduce the number of patients in the NEPHRO CRRT study.
• The FDA also agreed to broaden inclusion criteria, allowing enrollment of patients on CRRT beyond 48 hours and heparin-tolerant individuals.
• These changes aim to accelerate enrollment in the NEPHRO CRRT study, potentially supporting its completion by the end of 2025.
• Niyad, a lyophilized formulation of nafamostat, is being investigated as an anticoagulant for extracorporeal circuits in the NEPHRO CRRT trial.
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