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FDA grants Priority Review for sNDA to convert FILSPARI® from accelerated approval to full approval for the treatment of IgAN in the U.S.; PDUFA target action date of September 5, 2024 Received 511...
First non-immunosuppressive therapy for the treatment of IgA nephropathy approved in Europe Conditional marketing authorization is based on statistically significant and clinically meaningful...
Submission is based on 2-year confirmatory results from the Phase 3 PROTECT Study in which FILSPARI demonstrated a significant reduction in proteinuria, preservation of kidney function and a generally...
Operator: Good day and welcome to the Travere Therapeutics Fourth Quarter and Full Year 2023 Financial Results and Corporate Update Conference Call. Today's conference is being recorded.
15.02.2024 - Received 459 new patient start forms (PSFs) for FILSPARI (sparsentan) in Q4 2023; Total of 1,452 PSFs received in 2023 Company nearing submission of sNDA to convert U.S. accelerated approval of FILSPARI in IgAN to full approval ...