Travere Therapeutics, Ligand In Focus As FDA Set To Rule On Filspari Next Week – First FSGS Drug At Stake

• The FDA had extended the review of its supplemental New Drug Application for Filspari in January 2026.
• Citi kept a $48 price target for Travere, adding that it expects the FDA to approve the drug.
• If approved, Filspari would become the first treatment specifically indicated for FSGS, a rare kidney disorder.

Shares of Travere Therapeutics (TVTX) and Ligand Pharmaceuticals (LGND) are drawing increased investor attention ahead of a key U.S. Food and Drug Administration decision on Filspari, a treatment for a rare kidney disease, expected on April 13.

Ligand has a licensing agreement with Travere for Sparsentan, sold under the Filspari brand, under which Ligand will receive milestone payments and a 9% royalty on future global net sales of the drug.

At the time of writing, TVTX and LGND shares were little changed in pre-market trading on Friday.

FDA Did Not Seek Additional Information On Safety And Manufacturing

In January, Travere Therapeutics announced that the FDA extended the review of its supplemental New Drug Application (sNDA) for Filspari in focal segmental glomerulosclerosis (FSGS), setting a Prescription Drug User Fee Act (PDUFA) target action date of April 13, 2026. The FDA did not request any additional information related to the drug’s safety or manufacturing.

A PDUFA date is the FDA’s target date for making a decision on a drug application, which allows the drug to be marketed in the U.S.

If approved, Filspari would become the first treatment specifically indicated for FSGS, a rare kidney disorder that can lead to progressive loss of kidney function and eventual kidney failure. Filspari is an oral, non-immunosuppressive therapy.

Citi Expects FDA Approval

Last month, Citi maintained Travere Therapeutics’ ‘Buy’ rating and $48 price target. The firm expects the FDA to approve Filspari and added that the current share price does not fully reflect the company’s opportunity in FSGS.

Travere’s Phase 3 study met its interim goal for proteinuria reduction but did not meet the primary kidney function endpoint. However, longer-term results showed the drug improved proteinuria, remission rates, and reduced progression to kidney failure, while remaining well-tolerated. Proteinuria is the high concentration of protein, usually albumin, in urine.

How Did Retail Traders React?

Retail sentiment on Stocktwits was ‘bullish’ for TVTX and ‘neutral’ for LGND.

One user expects TVTX stock to decline if there is no update before Friday’s close.

However, another user expected a pre-FDA run-up to $32 - $35.

Year-to-date, TVTX shares have declined 20% while LGND stock has gained around 5%.

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