Advicenne: good news from the USA boosts share price

(CercleFinance.com) - Advicenne shares soared by more than 50% on Tuesday morning on the Paris Bourse, after announcing that the FDA had authorized the filing of a marketing authorization application for the treatment of distal renal tubular acidosis (dRTA).


The French pharmaceutical company reports that the American health authority has deemed the European data satisfactory for the filing of a registration dossier, without the need for an additional clinical study in the USA.

As a result, the company will not need to conduct a specific trial
in the U.S., significantly reducing the time and cost required to bring ADV7103, its lead drug, to market in this indication.

In renal tubular acidosis, the renal tubules do not function properly, leading to very high levels of acids in the blood.

"The latest exchanges with the US Food and Drug Administration have been particularly pragmatic and fruitful", commented Didier Laurens, Advicenne's CEO.

According to the CEO, these interactions demonstrate the quality of the clinical data we have accumulated in recent years, and the expertise of the teams in place.

In other good news, the granting of orphan drug status to ADV7103 in cystinuria last March has enabled us to validate our regulatory and clinical strategy with the FDA

With a new round of exchanges due to take place before the end of 2024, Advicenne should be authorized to set up a clinical trial enrolling patients simultaneously in the United States and Europe,
enabling a registration application to be filed in both territories.

Cystinuria, a disease characterized by an inherited abnormality of the renal tubules, affects around 30.000 patients in the US and 40,000 in Europe, representing a significant potential market for ADV7103.

While several players in the pharmaceutical industry had already shown an interest in ADV7103 in its two indications in the US, Advicenne has now received a first proposal for the rights to ADV7103 in the US, the terms of which remain confidential.

From its point of view, the latest steps taken should generate further expressions of interest, which the company intends to pursue actively from the end of 2024.

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