Travere Therapeutics to Submit sNDA for FILSPARI® (sparsentan) in FSGS
Portfolio Pulse from
Travere Therapeutics plans to submit a supplemental New Drug Application (sNDA) for FILSPARI, targeting FSGS, a rare kidney disorder. The submission is expected by the end of Q1 2025, following positive results from Phase 3 and Phase 2 studies. If approved, FILSPARI could become the first approved treatment for FSGS.
February 11, 2025 | 12:15 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Travere Therapeutics is set to submit an sNDA for FILSPARI, potentially the first approved treatment for FSGS. This follows a successful Type C meeting with the FDA and positive study results.
The news of Travere Therapeutics planning to submit an sNDA for FILSPARI, with potential to be the first approved treatment for FSGS, is significant. The successful Type C meeting with the FDA and positive results from clinical studies suggest a favorable regulatory outcome, likely boosting investor confidence and stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100