Catatan sumber primer
MaterialPermohonan diajukan
Opus Genetics mengajukan sNDA untuk phentolamine 0.75% pada presbiopia
Opus Genetics mengajukan supplemental New Drug Application (sNDA) untuk phentolamine ophthalmic solution 0.75% untuk pengobatan presbiopia. FDA diperkirakan akan mengeluarkan keputusan regulasi pada akhir 2026. Pengajuan ini menambahkan indikasi komersial baru yang potensial pada program molekul kecil yang dipartnershipkan perusahaan.
Fakta utama
- Diajukan
- 8 Jan 2026, 12.10
- Peristiwa
- Permohonan diajukan
- Arah
- Positif
- Perusahaan
IRDOpus Genetics- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 ef20062523_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Opus Genetics Highlights 2025 Progress and Upcoming 2026 Catalysts - Multi-asset pipeline with significant targeted data readouts and milestones - - Two lead ophthalmic gene therapy programs in clinical trials with new data anticipated in 2026 - - Supplemental New Drug Application (sNDA) submitted for partnered presbyopia treatment - - Corporate presentation at J.P. Morgan Healthcare Conference on Thursday, January 15, at 8:15 a.m. PT - RESEARCH TRIANGLE PARK, N.C. – January 8, 2026 - Opus Genetics, Inc . (Nasdaq: IRD) (the “Company,” “Opus,” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), tod
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