NEW YORK, Jan 13, 2026, 14:32 (EST) — Regular session
- Shares of LGND dropped roughly 11% following the FDA’s decision to extend the review period for partner Travere’s Filspari label expansion
- Travere announced the FDA reset the deadline to April 13, classifying the latest responses as a “major amendment.”
- Investors are shifting focus to April’s decision and upcoming updates on Filspari sales and launch plans
Shares of Ligand Pharmaceuticals Incorporated dropped 10.6% to $184.80 in Tuesday afternoon trading. The decline followed an announcement from royalty partner Travere Therapeutics that U.S. regulators extended the review period for its Filspari application, pushing the decision date to April 13. Travere said the FDA classified its latest submission as a “major amendment” but didn’t request additional safety or manufacturing data. LGND shares opened at $196.96 and fluctuated between $175.89 and $206.78. (Business Wire)
The timing cuts deep, given this was a straightforward, immediate trigger for Ligand’s royalty setup. Traders had marked the PDUFA date—the FDA’s deadline to decide on a drug application—as a moment for a label-expansion decision, not another round of waiting.
The extended review keeps focus on the clinical debate surrounding FSGS. In a late-stage trial, 37.5% of patients taking sparsentan saw reduced protein levels in urine compared to 21.4% on irbesartan, but the drug didn’t show a clear effect on slowing kidney function decline, said John Sperati, associate professor at Johns Hopkins University School of Medicine. Novartis is running a mid-stage trial testing atrasentan for FSGS. (Reuters)
Ligand’s stake stems from its license deal with Travere, which entitles Ligand to 9% net royalties on global net sales of Filspari. (Ligand)
Travere’s shares plunged 19% to $27.61, reflecting the sharp market reaction to the updated FDA timeline.
The broader biotech sector held firm, indicating this wasn’t a full-on selloff. The SPDR S&P Biotech ETF slipped roughly 0.6%, while the iShares Nasdaq Biotechnology ETF dipped about 0.4%.
Leerink Partners analyst Joseph Schwartz noted the FDA “has not yet gone through all of this new information,” warning that last-minute data submissions could prolong the review or result in a complete response letter. That letter is the FDA’s formal rejection, detailing what additional information it requires. (Investors)
Ligand positioned Filspari as just one piece of a broader royalty portfolio. At its December investor day, the company rolled out 2026 guidance targeting total revenue between $245 million and $285 million, with royalty revenue expected in the $200 million to $225 million range. Filspari was named alongside Ohtuvayre and Capvaxive (Merck), Qarziba (Recordati), and Zelsuvmi (Pelthos) as the main royalty revenue contributors. (Ligand)
Travere reported Monday that it closed 2025 with a record number of quarterly patient start forms. It estimates U.S. net sales of Filspari reached roughly $103 million in Q4, pushing full-year sales to around $322 million. The company plans to release full-year results and a corporate update in February. (Travere Therapeutics)
Delays tend to snowball, and for Ligand, the risk is straightforward: a postponed FDA ruling could stall royalty growth forecasts, especially since a few partner drugs dominate the near-term outlook.
