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Regulatory News: Advicenne (Euronext: ADVIC) (BSE:ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases
Message : Required fields Advicenne receives positive feedback from the US FDA on pathway to approval and amended Phase III study protocol for its treatment of distal renal tubular acidosis (dRTA) FDA accepts amended protocol and Advicenne will resume Phase III trial of its lead product ADV7103 (Sibnayal™) in the US in June 2021 FDA guidance provides clear path for market approval of ADV7103 in the United States Paris, France, 17 May 2021 - 6 pm CEST - Advicenne (Euronext: ADVIC), a specialty pharmaceutical company dedicated to developing and commercializ...
Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal) and announces Leadership Changes to support Commercialisation Regulatory News: Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, is pleased to announce that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal), for the treatment of distal renal tubular acidosis (dRTA). This approval makes ADV7103 the first and only...
Advicenne: 2021 Financial Calendar Event * Subject to change. Publication after market close. 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. Headquartered in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was cross-listed on the E...
Advicenne Provides an Update as its Operations Evolve Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC) provides an update on the overall progress of the Company. In Europe, with the recent positive CHMP Opinion for our lead medicine ADV7103-Sibnayal, Advicenne should receive the EMA Marketing Authorization (MAA) for Sibnayal soon. The company is currently pursuing discussions with several partners for its commercialization in most countries of the European Community. Meanwhile the clinical program in cystinuria in the EU is progressing. In spite of the hurdles encountered due to the ongo...