Advicenne (Euronext Growth Paris: FR0013296746—ALDVI) has announced the submission of a registration application to the FDA for Sibnayal—a fixed-dose combination of potassium citrate and potassium bicarbonate—for the treatment of distal renal tubular acidosis (dRTA).
According to Advicenne, the FDA has designated Sibnayal an orphan drug in dRTA, in the U.S. The evaluation of the dossier should take approximately 12 months. The company will communicate on the main stages of the evaluation process as well as on the expected date of the U.S. authorities’ decision—PDUFA date—which is expected within a few weeks.
Advicenne’s management plans to hold a web conference on November 5, 2025 at 5:45 PM CET.
