New York, January 13, 2026, 14:17 (EST) — Regular session
Shares of Travere Therapeutics (TVTX.O) dropped 19% to $27.56 in early afternoon trading Tuesday after the U.S. Food and Drug Administration extended its review of the kidney drug Filspari for broader use. The stock had fallen as much as 34% earlier, hitting a low of $22.35. (Reuters)
The delay comes during a week investors saw as crucial for the small-cap drugmaker’s regulatory path. Winning an expanded label for focal segmental glomerulosclerosis (FSGS) would unlock a fresh market, beyond the drug’s existing approval for IgA nephropathy. Traders had pegged this decision as a key short-term catalyst for the stock.
Travere said the FDA classified its latest submission as a “major amendment” to the supplemental new drug application, pushing back the user-fee deadline — the agency’s expected decision date — to April 13. “We remain focused on the goal of bringing FILSPARI to the patients who urgently need an effective medicine,” CEO Eric Dube said. (Business Wire)
Travere released preliminary numbers on Monday ahead of its full earnings report, forecasting total U.S. net product sales around $127 million for Q4 and roughly $410 million for 2025. The company said it closed 2025 with about $323 million in cash, cash equivalents, and marketable securities. FILSPARI net product sales hit approximately $103 million for the quarter and $322 million for the year. Additionally, Travere reported 908 new patient start forms during the quarter. (SEC)
Leerink Partners analyst Joseph Schwartz noted that the recent back-and-forth with the FDA increased the chances of a review delay and left the possibility of a complete response letter—a formal rejection that usually requires additional work—still alive. “We think it is fair to assume the agency has not yet gone through all of this new information,” he said. (Investors)
Travere is pushing the narrative beyond a single regulatory update, highlighting key 2026 targets. The company remains on track to restart its crucial Phase 3 trial for pegtibatinase in classical homocystinuria in Q1. Meanwhile, partner Chugai Pharmaceutical plans to file sparsentan in Japan this year. Travere also aims to release its full-year 2025 results come February. (Travere Therapeutics)
The FDA’s nod is specifically for FSGS, but investors are sizing up the company in the rapidly evolving IgA nephropathy space. Travere’s drug faces off against treatments from bigger names like Novartis and Otsuka, as well as Calliditas Therapeutics’ Tarpeyo. (Reuters)
That said, adding three months doesn’t solve the real challenge: how regulators evaluate clinical benefit in a condition where protein in the urine signals trouble, but preserving kidney function over time is the real goal. Should the FDA demand stronger proof that early drops in proteinuria lead to lasting kidney protection, both timelines and costs could balloon.
