Travere: FDA nagpalawig ng FILSPARI sNDA PDUFA hanggang Abril 13, 2026

Nagpalawig ang FDA ng PDUFA target action date para sa FILSPARI sNDA sa FSGS mula sa dating petsa patungong Abril 13, 2026 matapos iklasipika ang mga kamakailang tugon ng kumpanya bilang Major Amendment. Ang pagpapalawig ay dulot lamang ng pangangailangan na suriin ang karagdagang datos ng klinikal na benepisyo; walang bagong tanong tungkol sa kaligtasan o pagmamanupaktura ang itinaas.

Mahahalagang fact

Na-file: Ene 13, 2026, 09:32 PM
Kaganapan: Pinalawig ang petsa ng PDUFA
Direksyon: Negatibo
Kumpanya: TVTXTravere
Asset: sparsentan
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 13, 2026 · Inaprubahan

Sipi mula sa source

tvtx-20260113 0001438533 false 0001438533 2026-01-13 2026-01-13 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________ FORM 8-K ___________________________ Current Report Pursuant to Section 13 or 15(d)of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 13, 2026 ___________________________ TRAVERE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) ___________________________ Delaware 001-36257 27-4842691 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 3611 Valley Centre Drive , Suite 300 San Diego , CA 92130 (Address of Principal Executive Offices, including Zip Code) ( 888 ) 969-7879 (Registrant’s Telephone Numbe

SEC 8-K