Deric Dube News Today

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. Todays 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 ...

Renalys expected to initiate registrational study in the second quarter of 2024 to support potential approval of sparsentan for IgA nephropathy in JapanSAN DIEGO, Jan. 25, 2024 -- Travere...

Letter

Received 459 new patient start forms for FILSPARI® in the fourth quarter of 2023; preliminary net product sales of FILSPARI totaled $15 million for the fourth quarter Company on track to submit...

After meeting with the FDA, Company to submit a supplemental New Drug Application to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® in IgAN to full approval ...

Operator: Good day, and welcome to the Travere Therapeutics Third Quarter 2023 Financial Results and Corporate Update Conference Call. Todays conference call is being recorded.