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     156  0 Kommentare Advicenne Provides an Update on Its Activities Following Its Annual General Meeting

    Regulatory News:

    Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, provides an update on its activities following its Annual General Meeting, which was held virtually on June 14, 2021.

    During the Annual General Meeting, a majority of shareholders voted for all resolutions as recommended by the Board of Directors. 4,379,697 shares were represented in voting, corresponding to 50,88% of the Company’s 8,607,568 shares. The full results of the AGM are posted on the Company’s website and can be found at the following link: https://advicenne.com/investors/.

    Over the course of the AGM, attendees were introduced to Advicenne 2.0, the Company’s new strategy to maximize value creation for shareholders, details of which can be found below.

    Advicenne 2.0: a clear strategic pathway

    Advicenne aims to capitalize on the recent EU marketing authorization (MA) for Sibnayal (ADV7103) in distal Renal Tubular Acidosis (dRTA), expanding approved use both geographically and therapeutically, with strict financial discipline and capital allocation, and backed by a strong and highly experienced management team.

    The first priority as part of the Advicenne 2.0 strategy is to complete a partnership in Europe to generate commercial sales of Sibnayal in dRTA following its marketing authorization by the European Medicines Agency (EMA). The company is identifying the appropriate partners to maximize market potential in the main European markets and provide its shareholders with the highest return.

    The second priority is to accelerate the clinical development of Sibnayal in the US in two indications: dRTA and cystinuria. Advicenne has recently received positive feedback from the US Food and Drug Administration (FDA) on an amended Phase III study protocol and on a pathway to approval for Sibnayal for the treatment of dRTA. This will enable Advicenne to resume before the summer its Phase III clinical trial, ARENA 2, in the US. The right resources will be allocated to run the US development program in accordance with the FDA requirements and anticipate a potential first marketing authorization in the US before the end of 2022. The first approval of Sibnayal in the US would be a major milestone for the Company and a significant value driver for shareholders.

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    Advicenne Provides an Update on Its Activities Following Its Annual General Meeting Regulatory News: Advicenne (Paris:ADVIC) (BSE:ADVIC) (Euronext: ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, provides an update on its …