Advicenne Announces the Unlimited Renewal of the Marketing Authorization for Sibnayal® in the United Kingdom

PARIS--(BUSINESS WIRE)--Regulatory News:

Advicenne S.A. (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 unlimited renewal of the Marketing Authorization (MA) for Sibnayal® (a fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the United Kingdom.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the unlimited renewal of MA for Sibnayal® effective June 2026. This renewal, which is mandatory five years after the initial grant, definitively validates the MA in the United Kingdom. Following the renewal of the marketing authorization in the European Union, the decision by the British authorities highlights the therapeutic profile of Sibnayal® in the treatment of dRTA, a serious renal conditions affecting children and adults.

Advicenne’s regulatory program is particularly robust, with several marketing authorizations obtained for Sibnayal® in the Gulf countries, the recent reimbursement approvals for Likozam® and Sibnayal® in the French market, as well as the review of the registration dossier for ADV7103 by the U.S. Food and Drug Administration and a decision expected on September 3, 2026.

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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, GB, KSA and UAE, and has been filed for a US NDA. ADV7103 is currently in late-stage development in cystinuria in Europe and the US. 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 2025 Universal Registration Document filed with the French financial market authority on April 24, 2026 (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 currently not considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial 6/6 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.