Clinical Trials
5
4 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
4
80.0%
Completed
1
20.0%
- Advicenne has voluntarily withdrawn its New Drug Application (NDA) for ADV7103 in the treatment of primary distal Renal Tubular Acidosis (dRTA) in the USA. - The withdrawal follows recognition that additional Chemistry, Manufacturing and Controls (CMC)-related work cannot be completed within the current FDA review cycle. - ADV7103 (Sibnayal®), approved in 2021, remains marketed in the European Union, the United Kingdom, Saudi Arabia, and the United Arab Emirates. - The company will host a shareholder webinar in French on Tuesday, September 1, 2026, at 6:00 PM to discuss the decision.
- The European Medicines Agency has renewed Advicenne's marketing authorization for Sibnayal, a fixed combination of potassium citrate and potassium bicarbonate, for treating distal renal tubular acidosis in the European Union starting January 2026. - This mandatory five-year renewal definitively validates the marketing authorization and represents a major milestone for the continued commercial development of Sibnayal in Europe. - The renewal is part of Advicenne's expanding regulatory program, which includes marketing authorization obtained in Saudi Arabia in July 2025 and a recent registration application filed with the US Food and Drug Administration. - Advicenne specializes in developing innovative treatments for rare kidney diseases, with Sibnayal currently in late-stage development for cystinuria in Europe and for both distal renal tubular acidosis and cystinuria in the US and Canada.
- Avanzanite Bioscience raised €32 million in Series A funding from MVM Partners to expand its pan-European rare disease commercialization platform across 32 countries. - The company reported record Q3 2025 performance with revenue tripling year-over-year and growing over 20% quarter-on-quarter since launching three orphan drugs. - Avanzanite's integrated business model addresses Europe's fragmented healthcare landscape by coordinating pricing, reimbursement, and regulatory strategies for rare disease therapies. - The funding will support new product partnerships, asset acquisitions, and scaling of regulatory and commercial operations to improve patient access to orphan medicines.
- Advicenne has submitted a registration application to the US FDA for Sibnayal® (ADV7103), a fixed-dose combination of potassium citrate and potassium bicarbonate for treating distal renal tubular acidosis. - The FDA evaluation process is expected to take approximately 12 months, with the PDUFA date to be announced within weeks. - Sibnayal® has already received marketing approval in the EU and GB for dRTA treatment and has been designated as an orphan drug in the USA. - The submission is supported by extensive clinical data from a pivotal European study conducted over more than six years in dRTA patients.
