Talphera Reports Q3 2026 Net Loss and Increases Niyad Peak Sales Forecast
Talphera (TLPH) reported a third-quarter net loss of $4.0 million, or $0.05 per diluted share, for the period ending September 30, 2026. Operating expenses rose to $3.8 million due to increased development costs for Niyad and pre-launch commercial preparations. The company maintains a cash position of $14.2 million, which management believes is sufficient to reach a potential PMA approval for Niyad in 2027. Key clinical updates include the NEPHRO study, which has exceeded 75% of its 70-patient enrollment target. Management has requested an FDA meeting to potentially conclude enrollment by year-end 2026. Additionally, Talphera raised its peak annual U.S. sales estimate for Niyad in CRRT to over $200 million, citing updated market research and favorable physician feedback regarding nafamostat as an alternative to citrate.
Tickers: $TLPH
Topics: clinical trial enrollment earnings report FDA regulatory process net loss revenue guidance
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