Travere Therapeutics Stock Slumps After FDA Extends Drug Review Timeline To April: Retail Is Divided On Eventual Approval

• The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit.
• The company submitted responses and the agency determined that the responses constitute a major amendment to the application. 
• The FDA is now expected to decide on the application by April 13, 2026.

Shares of Travere Therapeutics, Inc., (TVTX) traded 19% lower on Tuesday after the company announced that U.S. Food and Drug Administration (FDA) has extended the review timeline for its application seeking approval of Filspari in focal segmental glomerulosclerosis.

The FDA is now expected to decide on the application by April 13, 2026. The agency was initially expected to rule on the application by Jan. 13.

Why The Delay?

The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. The company submitted responses, and the agency determined that the responses constitute a major amendment to the application, and extended the review timeline, the company said. The agency requested no additional information on the safety or manufacturing of Filspari, it added.

According to Travere, Filspari would be the first medication indicated for focal segmental glomerulosclerosis if approved. FSGS is a kidney disease causing sclerosis, or scarring in some filters of the kidneys, leading to protein leakage, swelling, and potentially kidney failure.

CEO Eric Dube said that the company remains committed to working with the FDA during the extension period and making preparations for a potential commercial launch.

Filspari is also approved by the FDA to slow kidney function decline in adults with IgA nephropathy, a chronic autoimmune kidney disease where deposits of the immunoglobulin A (IgA) antibody build up in the kidney's filters, causing inflammation, scarring, and damage.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around TVTX stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels.

A Stocktwits user opined that the FDA would eventually reject the drug.

Another opined that the FDA wouldn’t have extended the review timeline if it was planning on a rejection.

TVTX stock has gained 48% over the past 12 months. 

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