Catatan sumber primer
PenentuHasil topline
Opus Genetics OPGx-BEST1 Fase 1/2 Kohort 1 data topline 3 bulan
Data Kohort 1 dosis rendah menunjukkan 75% pasien yang dapat dievaluasi memenuhi titik akhir mikroperimetri yang selaras dengan FDA dan 80% mengalami perbaikan struktural. Kohort 2 telah over-enrolled; data Kohort 1 6 bulan dan data Kohort 2 3 bulan kini diharapkan pada Q2 2027, dengan dosis uji coba pivotal direncanakan dimulai pada 2027.
Fakta utama
- Diajukan
- 11 Sep 2026, 11.48
- Peristiwa
- Hasil topline
- Arah
- Positif
- Perusahaan
IRDOpus Genetics- Aset
- OPGx-BEST1
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- dosis kohort 1
- 1.5 x 10^9 vg/mata
- dosis kohort 2
- 4.5 x 10^9 vg/mata
- peningkatan bcva
- 3/5 peserta
- topline kohort 2
- Q2 2027
- enrollment kohort 2
- 8 peserta
- peningkatan struktural
- 4/5 peserta
- dosis kohort 2 selesai
- Q4 2026
- peningkatan mikroperimetri
- 3/4 peserta
Kutipan sumber
EX-99.1 2 ef20081922_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 OPGx-BEST1 Gene Therapy Phase 1/2 Study Low Dose Cohort 1 3-month Results September 9, 2026 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Such statements include, but are not limited to, statements related to our continued clinical development, clinical results, preclini
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Penting
12 Jan 2026
14.00
IRDOpus GeneticsOpus Genetics: OPGx-BEST1 Fase 1/2 data awal diharapkan Q1 2026