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.
Clinical Trials
18
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
17
94.4%
Recruiting
1
5.6%
No approval data available
- Talphera has enrolled 35 of 70 patients (50% enrollment) in its NEPHRO-CRRT registrational trial testing nafamostat as an anticoagulant for continuous renal replacement therapy. - The company implemented FDA-approved protocol changes including a 60% reduction in patient enrollment requirements and focused on medical ICUs with nephrologists as principal investigators. - Talphera plans to complete the study and file a Premarket Approval (PMA) application in 2026, potentially making nafamostat the only FDA-approved regional anticoagulant for CRRT. - The company maintains $20.4 million in cash and investments as of December 2025, with projected 2026 operating expenses of $17-18 million to support trial completion.
- CorMedix invested $5 million in Talphera as part of a $29 million private placement to fund completion of the Phase 3 NEPHRO CRRT study for Niyad, a breakthrough-designated anticoagulant. - Niyad represents a potential first-in-class FDA-approved regional anticoagulant for continuous renal replacement therapy, targeting an estimated 165,000 acute kidney injury patients annually. - The strategic partnership grants CorMedix exclusive acquisition negotiation rights following Phase 3 results and a board seat, with Niyad approval anticipated in second half 2026.
- Talphera's stock jumped 20.21% following the announcement of 17 patients enrolled in its NEPHRO CRRT clinical trial, representing 25% of the 70-patient target. - Over 90% of enrolled patients come from newly added clinical sites, demonstrating improved enrollment efficiency and accelerating recruitment momentum. - The enrollment milestone is critical for securing the second tranche of Talphera's March 2025 financing and aligns with the Breakthrough Device Designation for Niyad. - CEO Vince Angotti expressed confidence in completing the trial by year-end, reducing regulatory uncertainty and validating the company's strategic pivot.
- Talphera has dramatically improved clinical trial enrollment for its nafamostat CRRT study, with over 90% of new patients enrolled from three optimized sites over the past six weeks. - The company reduced its pivotal Niyad trial size to 70 patients and lowered annual operating expenses to $16-17 million while maintaining its year-end 2025 completion timeline. - Talphera is pursuing a compassionate use IDE for nafamostat to address critical shortages of heparin and citrate anticoagulants in continuous renal replacement therapy. - The company's milestone-based financing structure provides funding contingent on enrollment targets and stock price performance above 73¢ per share.
- 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.
