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Investing.com - H.C. Wainwright has reiterated its Buy rating and $47.00 price target on Travere Therapeutics (NASDAQ:TVTX), whose shares have surged 29% in the past week to $27.31, following the company’s announcement regarding its drug FILSPARI. The broader analyst consensus remains bullish, with InvestingPro data showing 4 analysts recently revising earnings estimates upward.
Travere announced on September 10 that the FDA will no longer require an Advisory Committee meeting for the supplemental New Drug Application (sNDA) of FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS). The application’s PDUFA date remains scheduled for January 13, 2026.
The research firm views the cancellation of the Advisory Committee meeting as a positive development, especially when combined with the recent easing of REMS requirements for FILSPARI in IgA nephropathy (IgAN). The stock reacted favorably to the news.
H.C. Wainwright believes these developments suggest the FDA is comfortable with the strength of FILSPARI’s data across indications and has confidence in its regulatory outlook.
The sNDA is supported by results from the Phase 3 DUPLEX study and Phase 2 DUET study, which demonstrated clinically meaningful and sustained reductions in proteinuria compared to irbesartan, along with long-term remission benefits and a favorable safety profile.
In other recent news, Travere Therapeutics has made significant strides with its drug development efforts. The U.S. Food and Drug Administration (FDA) has decided that an advisory committee meeting is no longer necessary for the review of Travere’s supplemental New Drug Application (sNDA) for FILSPARI, aimed at treating focal segmental glomerulosclerosis (FSGS). The target action date for this regulatory decision remains January 13, 2026. This development is seen as a positive indicator for Travere, as analysts from Jefferies suggest it shows FDA support for using UPCR as the primary endpoint for full approval in FSGS. Additionally, Cantor Fitzgerald has reiterated an Overweight rating on Travere shares following the announcement. Meanwhile, H.C. Wainwright has maintained its Buy rating with a $47 price target, citing Travere’s adapted Risk Evaluation and Mitigation Strategy (REMS) as a competitive advantage. Jefferies also reiterated its Buy rating, setting a $35 price target, and highlighted the FDA’s decision as a significant positive development for the company. These recent updates reflect ongoing confidence from analysts in Travere’s strategic direction and regulatory progress.
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