Travere: FILSPARI sNDA sa FSGS ay may petsa ng PDUFA na Abril 13, 2026

Ang sNDA para sa FILSPARI sa FSGS ay nananatili sa ilalim ng pagsusuri ng FDA na may target na petsa ng aksyon ng PDUFA na Abril 13, 2026. Ayon sa kumpanya, ito ay handa na para sa posibleng komersyal na paglulunsad kung aprubado. Tinutukoy nito ang susunod na regulatory milestone para sa indikasyon ng FSGS.

Mahahalagang fact

Na-file: Peb 19, 2026, 09:05 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: TVTXTravere
Asset: sparsentan
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 13, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 aex991_2025q4x10xkearnings.htm EX-99.1 Document EXHIBIT 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results U.S. net product sales of FILSPARI reached $103 million, representing 108% growth compared to prior year period; all-time high 908 new PSFs received during the quarter U.S. net product sales of FILSPARI totaled $322 million for full year 2025; total net product sales were $410 million for full year 2025 PDUFA target action date for FILSPARI in FSGS is April 13, 2026; Company positioned for a successful commercial launch, if approved Enrollment activities have resumed for the pivotal Phase 3 HARMONY Study of pegtibatinase in classical HCU SA

SEC 8-K