Business Wire

Advicenne: Precision on the Press Release Dated March 19, 2021

PARIS–(BUSINESS WIRE)–Regulatory News:

Advicenne (Euronext: ADVIC) (the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapeutic products for rare kidney disease, wishes to clarify today the content of its press release issued on March 19, 2021 concerning the communication that “it anticipates imminent European Marketing Authorization for its lead product ADV7103 (Sibnayal™)” for dRTA in Europe.

The reference to an “imminent” authorization means that the Company expects such approval to occur shortly, and no later than the end of the second quarter of 2021.

Except for the above, the French and English versions of the press release dated March 19, 2021 remain unchanged.

About Advicenne

Advicenne (Euronext: ADVIC) is a pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead drug candidate is currently in late-stage clinical trials for two kidney diseases: the renal tubular acidosis and cystinuria. ADV7103 has recently received a positive CHMP opinion for the treatment of dRTA.

This is the second time Advicenne has obtained a marketing authorization for an innovative pediatric specialty it has fully developed: OZALIN, a formulation of midazolam for conscious sedation in children was registered in 2018 and is currently marketed in Europe by Primex.

Headquartered in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was cross-listed on the Euronext Brussels stock exchange in 2019.

For additional information see: www.advicenne.com

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Advicenne, which shall not be considered per se as historical facts. Such statements include projections and estimates, and the hypotheses on which these are based, as well as observations relating to operations, ongoing projects, objectives, the development of products and their future performance, and expectations regarding financial results.

In some cases, forward-looking statements can be identified by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets” or similar words. Although the management of Advicenne believes that these forward-looking statements are reasonably made, investors should be aware that they are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, the expectations of Advicenne could be affected by, among other things, uncertainties involved in the placing on the market and commercialization of Advicenne products or any other risks and uncertainties developed or identified in any public documents filed by Advicenne with the French Financial Markets Authority (Autorité des marchés financiers (AMF)), including those listed in Chapter 4, “Risk Factors,” of its universal registration document, filed with the latter on December 22, 2020. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be “accurate, precise and fairly presented”), Advicenne disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Advicenne
Peter Meeus, CEO

+33 (0)4 66 05 54 20

E-mail: [email protected]

Financial Communications
NewCap

Dusan Oresansky, Emmanuel Huynh

+33 (0)1 44 71 94 92

Press Relations
NewCap

Nicolas Merigeau

+33 (0)1 44 71 94 98

E-mail: [email protected]

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Comment moderation is enabled. Your comment may take some time to appear.

Back to top button