AcelRx Announces Rebranding With Name Change to Talphera, Inc.

Core Viewpoint - AcelRx Pharmaceuticals, Inc. has rebranded to Talphera, Inc. to reflect its new mission of developing innovative therapies for medically supervised settings, moving beyond its original focus on acute pain [1][2]. Company Overview - Talphera, Inc. is a specialty pharmaceutical company focused on innovative therapies for medically supervised settings, with its lead product candidate being Niyad, a formulation of nafamostat [6][7]. - The name "Talphera" is derived from "Talisman," symbolizing a strong leader and a new pharmaceutical era for the company [2]. Product Development - Talphera's lead product candidate, Niyad, has received FDA Breakthrough Designation and is being studied as an anticoagulant for the extracorporeal circuit [3][6]. - The company plans to initiate the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, which has received IRB approval and will evaluate 166 adult patients [4][5]. Regulatory and Market Strategy - A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024 [5]. - The first patient for the NEPHRO study is anticipated to be enrolled in the first quarter of 2024 [5].