Travere: FILSPARI FSGS sNDA PDUFA itinakda sa Enero 13, 2026

Nakasaad sa dokumento na ang target na petsa ng aksyon ng PDUFA para sa supplemental NDA na naghahanap ng buong pag-apruba ng FILSPARI sa FSGS ay Enero 13, 2026. Tumugon na ang kumpanya sa mga kamakailang kahilingan ng impormasyon mula sa FDA at kasalukuyang sinusuri ang mga tugon. Kung aprubado, ang FILSPARI ang magiging unang gamot na aprubado para sa FSGS.

Mahahalagang fact

Na-file: Ene 12, 2026, 10:04 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_2025q4xearningsprex.htm EX-99.1 Dokumento EXHIBIT 99.1 Contact: Investors: Media: 888-969-7879 888-969-7879 IR@travere.com mediarelations@travere.com Travere Therapeutics Provides Corporate Update and 2026 Outlook U.S. FILSPARI reaches all-time highs of 908 new PSFs and net product sales of approximately $103 million in 4Q 2025 Company positioned for successful commercial launch of FILSPARI in FSGS, if approved Pivotal Phase 3 HARMONY Study of pegtibatinase in classical HCU to restart in 1Q 2026 SAN DIEGO, January 12, 2026 – Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects total U.S. net product sales for the fourth quarter of 2025 to be approximately $127 million. For the fiscal y

SEC 8-K