Talphera Proposes FDA Plan to Conclude NEPHRO Study by End of 2026 and Increases Niyad Sales Forecast
Talphera (TLPH) has submitted a briefing document to the FDA requesting a Sprint Meeting to discuss its proposed strategy for closing the NEPHRO clinical study. The company aims to conclude enrollment and finalize the study by December 31, 2026. In addition to the regulatory update, management raised its peak U.S. sales projections for Niyad to over $200 million. This shift reflects updated commercial expectations as the company progresses through its clinical development milestones.
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