Travere: FILSPARI sNDA para sa FSGS ay may PDUFA date na Enero 13, 2026

Ang sNDA para sa FILSPARI sa FSGS ay nananatili sa ilalim ng pagsusuri ng FDA na may kumpirmadong PDUFA target action date na Enero 13, 2026. Ipinabatid ng FDA sa kompanya na hindi na kailangan ng advisory committee matapos ang karagdagang pagsusuri. Kung aprubado, ang FILSPARI ang magiging unang at tanging gamot na aprubado ng FDA para sa FSGS.

Mahahalagang fact

Na-file: Okt 30, 2025, 08:06 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Positibo
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 a2025q3_8-kxex991.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 Third Quarter 2025 Financial Results U.S. net product sales of FILSPARI ® (sparsentan) grew 155% year-over-year to $90.9 million in 3Q 2025; 731 new PSFs received during the quarter Total revenue for 3Q 2025 was $164.9 million, including U.S. net product sales of $113.2 million Retired remaining $69 million of 2025 convertible notes and achieved $40 million EU market access milestone, further strengthening financial foundation 2025 KDIGO guidelines and streamlined REMS monitoring strengthen FILSPARI’s position as a foundational, nephroprotective therapy for IgAN Company well-positioned for potential FD

SEC 8-K