- This extensive clinical dataset serves ADV7103 registration dossier in the United States of America, expected to be submitted in Q4 2025
Regulatory News:
Advicenne (Euronext Growth Paris FR0013296746 ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, announces the publication in Orphanet Journal of Rare Disease (OJRD) of the long-term results of the pivotal study of ADV7103 in the treatment of distal renal tubular acidosis (dRTA).
This European study conducted over more than six years in patients with dRTA, provides long-term clinical follow-up data on this rare disease and contributes to a better understanding of the natural history of patients affected by this rare disease.
The publication is available here.
These clinical results form the core of the clinical part of the registration dossier for ADV7103 in the United States, which is expected to be submitted in Q4 2025.
About Advicenne
Advicenne (Euronext Growth Paris ALDVI FR0013296746) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022.
For additional information, see: https://advicenne.com/.
Disclaimer
This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2024 Universal Registration Document filed with the French financial market authority on April 29, 2025 (a copy of which is available on www.advicenne.com) and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
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Contacts:
Advicenne
Didier Laurens, Directeur Général
+33 (0) 1 87 44 40 17
Email: investors@advicenne.com
Ulysse Communication
Media relations
Bruno Arabian
+33 (0)6 87 88 47 26
Email: advicenne@ulysse-communication.com
