Monitor upcoming catalysts: BEST1 3-month data in September 2026, PDUFA for Phentolamine in October 2026, and LCA5 Phase 3 dosing initiation in Q4 2026. These represent key inflection points for the stock. The early LCA5 data is encouraging but from very small cohorts.
Price Chart
Executive Summary
Opus Genetics held its Virtual R&D Science Forum on June 16, 2026, providing updates on its gene therapy pipeline for inherited retinal diseases (IRDs). The company highlighted cash runway into 2029, upcoming milestones including BEST1 3-month data (Sept 2026), LCA5 Phase 3 dosing initiation (Q4 2026), and early positive LCA5 data in small cohorts. No financial results or guidance were provided.
Key Facts
- Cash runway into 2029 funds five clinical programs through potential product approvals and PRV opportunities.
- Upcoming milestones: BEST1 Cohort 1 3-month results (Sept 2026), PDUFA date for Phentolamine sNDA (Oct 2026), LCA5 Phase 3 dosing initiation (Q4 2026), RDH12 clinical study initiation (Q4 2026), MERTK clinical study initiation (Q1 2027), RHO clinical study initiation (2H 2027).
- LCA5 Phase 1/2 data (N=3 adult, N=3 pediatric) showed maintained or improved visual acuity over 6-24 months, with durable full-field stimulus test improvements.
- BEST1 Phase 1/2 has enrolled 5 participants; baseline demographics provided, no efficacy data yet.
- Partnership with Abu Dhabi Department of Health for MERTK program; high MERTK patient prevalence in Middle East/North Africa (~14,300 vs ~2,600 in U.S.).
- Prevalence estimates for target IRD genes across U.S., EU4+UK, Middle East/North Africa, and China total ~123,000 patients.
Financial Impact
No financial data reported; company is pre-revenue with cash runway into 2029.
Risk Factors
- Clinical trial risks: small sample sizes, potential for negative or inconclusive data in larger studies.
- Regulatory risks: FDA approval not guaranteed for any pipeline program.
- Dilution risk: company may need additional capital beyond current cash runway.
- Competition from other gene therapy developers targeting similar IRD indications.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001140361-26-025363 |
| Document: ef20076261_8k.htm | 0001140361-26-025363 |
| Document: 0001140361-26-025363-index-headers.html | 0001140361-26-025363 |
| Document: 0001140361-26-025363-index.html | 0001140361-26-025363 |
| Document: 0001140361-26-025363.txt | 0001140361-26-025363 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | SC 13G | $3.32 | awaiting T+60 | — | $3.46 (+4.22%) |
Oct 27, 2026 today | Insider Cluster | $3.32 | awaiting T+60 | — | $3.46 (+4.22%) |
Oct 23, 2026 4d ago | 144 | $3.32 | awaiting T+60 | — | $3.46 (+4.22%) |
Oct 21, 2026 6d ago | 8-K | $3.82 | awaiting T+60 | — | $3.46 (−9.42%) |
Oct 15, 2026 12d ago | 8-K | $3.84 | awaiting T+60 | — | $3.46 (−9.90%) |
Oct 15, 2026 12d ago | Press Release | $3.84 | awaiting T+60 | — | $3.46 (−9.90%) |
Sep 22, 2026 5w ago | Institutional Cluster | $5.16 | awaiting T+60 | — | $3.46 (−32.95%) |
Sep 11, 2026 6w ago | 8-K | $6.04 | awaiting T+60 | — | $3.46 (−42.72%) |
Sep 9, 2026 6w ago | 8-K | $5.73 | awaiting T+60 | — | $3.46 (−39.62%) |
Sep 2, 2026 7w ago | Press Release | $4.45 | awaiting T+60 | — | $3.46 (−22.25%) |
US Market Status
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