Travere’s Filspari Gains FDA Nod for FSGS, Shares Soar 34.7%
FDA granted full approval for Filspari (sparsentan) to treat focal segmental glomerulosclerosis, opening a market of over 40,000 U.S. patients. Following the announcement, Travere Therapeutics shares jumped 34.7% to $41.35, prompting Piper Sandler to upgrade the stock to Overweight with a $49 price target.
1. FDA Approval for FSGS Indication
The FDA granted full approval for sparsentan (Filspari) to treat focal segmental glomerulosclerosis (FSGS) in adults and pediatric patients eight years and older, making it the first and only therapy for this rare condition affecting over 40,000 U.S. patients. The dual receptor antagonist mechanism reduces proteinuria and aims to slow disease progression.
2. Stock Reaction and Analyst Upgrade
Following the approval announcement, Travere Therapeutics shares surged 34.7% to $41.35, marking a new 52-week high. Piper Sandler upgraded the stock to Overweight and set a $49 price target, reflecting increased confidence in the drug’s commercial potential.
3. Drug Pricing and Sales Outlook
Filspari’s list price for FSGS patients is expected to approach $20,000 per month, nearly double its IgA nephropathy rate, indicating potential annual per-patient revenue around $240,000. The therapy generated $103.3 million in sales in the last quarter, supporting Travere’s revenue growth trajectory.
4. Competitive Landscape and Licensing
Competitor Atrasentan from Novartis is in mid-stage trials for FSGS, while Travere’s agreement with Ligand Pharmaceuticals grants Ligand 9% of global revenue plus milestone payments. This licensing structure will influence Travere’s net margin on Filspari sales.