SAN MATEO, Calif. - AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company, announced its rebranding to Talphera, Inc. ("Talphera"). The rebranding aims to reflect the company's expanded focus on developing therapies for medically supervised settings beyond acute pain management. Along with the name change, Talphera will start trading on the Nasdaq Global Market under the new ticker symbol "TLPH" starting Wednesday, January 10, 2024.
The company's strategic shift is underscored by its lead product candidate, Niyad, which is being studied as an anticoagulant for extracorporeal circuits and has been granted FDA Breakthrough Designation. Talphera's NEPHRO CRRT Study, a Phase 3 trial for Niyad, has received Institutional Review Board (IRB) approval and will soon enroll its first patient. The trial aims to evaluate Niyad's effectiveness in patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk for bleeding. A Premarket Approval (PMA) submission for Niyad is anticipated in the second half of 2024.
CEO Vince Angotti emphasized the company's commitment to advancing care in medically supervised settings, stating that the rebranding to Talphera marks a new era with a broader mission. Talphera is also developing two pre-filled syringes, Fedsyra and PFS-02, in-licensed from partner Aguettant.
Nafamostat, the active ingredient in Niyad, has shown potential in various therapeutic areas, including anticoagulation and anti-inflammatory treatments, and is being investigated for anti-viral applications.
The company's transformation from AcelRx to Talphera is presented as a strategic evolution, with the new name derived from "Talisman" to signify leadership in a new pharmaceutical era.
The information in this article is based on a press release statement.
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