Advicenne: progress in discussions with the FDA

(CercleFinance.com) - Advicenne announced on Tuesday evening that it had reached a "major milestone" in its discussions with the FDA regarding the development in the USA of its lead drug, ADV7103, for cystinuria.


The pharmaceutical company reports that its latest discussions with the FDA are in line with a clinical trial characterized by a "limited" duration and number of patients.

According to analysts, this option should make it possible to reduce development costs and bring forward the timeframe for the next market launch.

In a press release, Advicenne explains that it plans to recruit patients in both the United States and Europe, and intends to file for registration simultaneously in both territories.

For the record, ADV7103 has orphan drug status in the cystinuria indication in both Europe and the USA.

Cystinuria, a kidney disease caused by a hereditary defect in the tubular reabsorption of an amino acid, affects around 30,000 patients in the USA and 40,000 in Europe, representing a significant potential market for ADV7103.

After opening the session with gains of over 6%, Advicenne shares turned downwards at mid-day, and were down 0.5% at around 2:40 pm.

At yesterday's close, the stock was up nearly 115% on its all-time lows recorded last September.

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