Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy...
Travere Therapeutics, Inc. (TVTX)
Company Research
Source: GlobeNewswire
SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) to full approval. In February 2023, the FDA granted accelerated approval to FILSPARI as the first and only non-immunosuppressive treatment targeting glomerular injury in the kidney to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator. “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN. The submission of the sNDA is an important step toward potentially gaining full approval in IgAN in support of reaching more people
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TVTX
News
- Travere Therapeutics, Inc. (NASDAQ: TVTX) had its price target raised by analysts at HC Wainwright from $17.00 to $19.00. They now have a "buy" rating on the stock.MarketBeat
- Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA NephropathyGlobeNewswire
- CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA NephropathyPR Web
- CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy [Yahoo! Finance]Yahoo! Finance
- CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA NephropathyPR Newswire
TVTX
Earnings
- 2/15/24 - Beat
TVTX
Sec Filings
- 4/24/24 - Form 8-K
- 4/12/24 - Form 4
- 3/27/24 - Form ARS
- TVTX's page on the SEC website