Sibnayal (ADV7103; potassium citrate / potassium bicarbonate)

Note: Advicenne official press release, Paris, January 19, 2026: 'The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026.' FDA accepted the New Drug Application for Sibnayal (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for distal renal tubular acidosis; NDA submitted November 2, 2025 and filed as a 505(b)(2) incorporating the European clinical studies. Sibnayal already holds marketing authorization in the EU and Great Britain for dRTA. No FDA designations are disclosed in the release, so none are asserted here. Advicenne is listed on Euronext Growth Paris (ALDVI, FR0013296746) and files no SEC reports. CAVEAT: Advicenne opened French safeguard proceedings on May 5, 2026 to restructure its financial liabilities; no change to the PDUFA date has been announced through 2026-08-02.