Opus Genetics, Inc. 8K

Opus Genetics reported positive early Phase 1/2 OPGx‑BEST1 gene therapy data and FDA-aligned plans to advance toward a pivotal trial, supported by a strong cash runway.

Opus Genetics, Inc. (Nasdaq: IRD) furnished a slide presentation as an exhibit to its Form 8-K describing 3‑month topline Phase 1/2 low‑dose Cohort 1 results for its OPGx‑BEST1 gene therapy in BEST1‑related retinal disease, reporting a favorable safety profile with no serious adverse events, dose‑limiting toxicities, or intraocular inflammation, and encouraging structural and functional efficacy signals that led an independent data monitoring committee to recommend advancing to a higher‑dose Cohort 2 and supported a constructive August 2026 FDA Type C meeting aligning on potential pivotal Phase 3 endpoints and a clinical development plan targeting Cohort 2 data and initiation of a pivotal trial in 2027, with management also highlighting sufficient cash runway into 2029 to fund multiple clinical programs through key inflection points.

Filing Facts

CIK

1228627

Ticker

-

Form

8K

Source Type

sec

Accession

0001140361-26-035979

Alert Tier

6