TVTX: Recent Regulatory Momentum Will Drive FSGS And IgAN Market Leadership

Travere Therapeutics' analyst price target increased from $35.71 to $38.50 per share, as analysts point to positive regulatory developments and continued strong prospects for Filspari, driving their upward revisions.

Analyst Commentary

• Bullish analysts highlight the cancellation of the FDA advisory committee meeting as a significant positive. This is seen as an indication of increased confidence in regulatory approval for Filspari within focal segmental glomerulosclerosis.
• There is growing sentiment that recent regulatory progress may accelerate approval timelines, which could offer potential upside to near-term revenue and growth forecasts.
• Price target increases across multiple firms reflect expectations for robust demand and ongoing strong execution in Filspari’s expansion, particularly in immunoglobulin A nephropathy and related indications.
• Positive reception of recent clinical results and management’s confidence in meeting PDUFA timelines are contributing to bullish views on the company’s growth prospects and valuation upside.

• Some bearish analysts continue to maintain a cautious stance and retain Hold ratings, even as price targets are raised, citing lingering uncertainties around the regulatory process.
• There are concerns about the possibility of unforeseen regulatory shifts or unexpected clinical data that could impact approval odds or commercialization timelines.
• Despite optimism, questions remain about the sustainability of Filspari’s early momentum and whether it can maintain strong growth over the long term.

What's in the News

• The FDA approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for FILSPARI, reducing liver function monitoring to every three months and removing embryo-fetal toxicity monitoring requirements. (Key Developments)
• The FDA informed Travere Therapeutics that a scheduled advisory committee meeting for the supplemental New Drug Application (sNDA) for FILSPARI in focal segmental glomerulosclerosis (FSGS) is no longer needed. The sNDA remains under review with a PDUFA target action date of January 13, 2026. (Key Developments)
• Travere will present 11 abstracts, including a late-breaking poster, at the upcoming American Society of Nephrology Kidney Week 2025. These will highlight new real-world data and analyses reinforcing FILSPARI’s efficacy in lowering proteinuria and preserving kidney function. (Key Developments)
• New data from the COMPOSE study show pegtibatinase maintained significant reductions in total homocysteine and methionine over 50 weeks in classical homocystinuria, supporting the ongoing Phase 3 HARMONY Study for potential approval. (Key Developments)

Valuation Changes

• Consensus Analyst Price Target has risen from $35.71 to $38.50 per share, reflecting increased optimism.
• Discount Rate increased slightly from 7.03% to 7.09%, suggesting a modest uptick in perceived risk.
• Revenue Growth forecast has fallen from 35.6% to 30.8%, indicating more conservative sales expectations.
• Net Profit Margin dipped from 26.6% to 25.5%, signaling a slight reduction in profitability outlook.
• Future P/E declined from 21.57x to 20.77x, pointing to marginally lower forward valuation multiples.