Catatan sumber primer
MaterialPermohonan diajukan
Protagonist: Aplikasi EMA diajukan untuk icotrokinra pada psoriasis plak
Aplikasi otorisasi pemasaran EMA untuk icotrokinra pada dewasa dan remaja dengan psoriasis plak sedang hingga berat diajukan pada September 2025, menyusul pengajuan NDA AS pada Juli 2025. Hal ini memajukan jalur regulasi menuju potensi persetujuan di AS dan UE pada 2026.
Fakta utama
- Diajukan
- 6 Nov 2025, 21.19
- Peristiwa
- Permohonan diajukan
- Arah
- Netral
- Perusahaan
PTGXProtagonist- Aset
- icotrokinra
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 tm2530353d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines Agency (EMA) application was submitted in September Rusfertide granted breakthrough designation for patients in Polycythemia Vera (PV) and the subject of four presentations including 52-week results of the VERIFY Phase 3 Study at ASH, the 67 th Annual American Society of Hematology (ASH) meeting in December First patient dosed in the Phase 1 trial of PN-881, a first-in-class oral IL-17 peptide antagonist IND-enabling studies progressing as planned with triple-GLP/GIP/GCG ag
