Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
IRD Catalyst Timeline
Dated clinical, regulatory and corporate events for Opus Genetics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Opus Genetics, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How IRD actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-10-14 | OPGx-BEST1 | Phase 1/2 data presentation | Phase 1/2 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phentolamine Ophthalmic Solution Small moleculeNCT07140783 | Vision Loss Night | Phase 3 | RECRUITING | 580 | Aug 1, 2027 | ||||||
| OPGx-LCA5 Gene therapyNCT05616793 | LCA5 | Phase 1 | RECRUITING | 22 | Jun 15, 2028 | ||||||
| OPGx-RDH12 Small moleculeNCT07681778 | Leber Congenital Amaurosis | Phase 1 | NOT YET_RECRUITING | 10 | Jul 1, 2034 | ||||||
| OPGx-BEST1 Gene therapyNCT07185256 | ARB | Phase 1 | RECRUITING | 10 | Aug 1, 2030 | ||||||
| Phentolamine Ophthalmic Solution Small moleculeMarketedNCT06542497 | Presbyopia | Phase 3 | COMPLETED | 569 | Jan 22, 2026 | ||||||
| Phentolamine Ophthalmic Solution Small moleculeMarketedNCT03960866 | Open Angle Glaucoma | Phase 2 | COMPLETED | 39 | Sep 11, 2019 | ||||||
| Phentolamine Ophthalmic Solution Small moleculeMarketedNCT04004507 | Decrease in Night Vision | Phase 2 | COMPLETED | 24 | Feb 1, 2008 | ||||||
| Phentolamine Ophthalmic Solution Small moleculeMarketedNCT04024891 | Mydriasis | Phase 2 | COMPLETED | 32 | Sep 17, 2019 | ||||||
| Phentolamine Ophthalmic Solution Small moleculeMarketedNCT01703559 | Night Vision Complaints | Phase 2 | COMPLETED | 60 | Apr 30, 2012 | ||||||
| APX3330 Small moleculeCompletedNCT04692688 | Diabetic Retinopathy | Phase 2 | COMPLETED | 103 | Jan 25, 2023 | ||||||
| Phentolamine 0.75% Small moleculeMarketedNCT06349759 | Mesopic Vision | Phase 3 | COMPLETED | 200 | Feb 19, 2026 | ||||||
| Phentolamine 0.75% Small moleculeMarketedNCT04638660 | Dim Light Vision Disturbances | Phase 3 | COMPLETED | 144 | May 19, 2022 | ||||||
| Phentolamine 0.75% Small moleculeMarketedNCT05223478 | Mydriasis | Phase 3 | COMPLETED | 576 | Apr 28, 2022 | ||||||
| Phentolamine Opthalmic 0.75% Small moleculeMarketedNCT05646719 | Presbyopia | Phase 3 | COMPLETED | 333 | Oct 11, 2023 | ||||||
| Phentolamine 0.75% Small moleculeMarketedNCT04675151 | Presbyopia | Phase 2 | COMPLETED | 150 | Jun 30, 2021 |
Clinical Trial Results
Readouts, endpoints and source filings for every IRD program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| OPGx-BEST1 | BEST1-associated retinal diseases | Phase 1/2 | 2026-10-15 | improved retinal sensitivity in 75% of evaluable participantsRead More | Opus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026Read More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Foundation Fighting Blindness Retinal Degeneration FundDirector, See Remarks | Sell | -556,000 3,236,171 held | $4.96 | 09/30/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in IRD
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in IRD for Q2 2026. | ||||
IRD Institutional Ownership Trends
IRD Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How IRD ranks across every disease it competes in
IRD News
Opus Genetics Announces FDA Clearance of IND Application for OPGx-RDH12 Gene Therapy for Inherited Childhood Blindness
Opus Genetics announced FDA clearance of its IND application for OPGx-RDH12, a gene therapy for RDH12-associated Leber congenital amaurosis. This clearance allows the company to initiate a Phase 1/2 clinical trial. The collaboration with the Global RDH12 Alliance aims to accelerate development for this rare condition affecting childhood vision.
Read more →Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Opus Genetics has received FDA approval for phentolamine ophthalmic solution 0.75% to treat presbyopia, a common age-related vision condition. This approval follows successful Phase 3 trials, which met all efficacy endpoints. The treatment offers a non-invasive option for adults, enhancing near vision without affecting distance vision. The approval also activates a milestone payment for Opus Genetics.
Read more →Opus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026
Opus Genetics presented promising clinical data for its gene therapy programs OPGx-BEST1 and OPGx-LCA5 at Retina in Rio 2026. The OPGx-BEST1 trial showed improved retinal sensitivity in 75% of participants, while OPGx-LCA5 demonstrated sustained visual acuity improvements over 24 months. The company aims to advance both programs, with Phase 3 dosing for OPGx-LCA5 expected in late 2026.
Read more →Opus Genetics to Present at the Chardan Annual Healthcare Conference
Opus Genetics, a clinical-stage biopharmaceutical company, will present at the Chardan Annual Healthcare Conference on October 20, 2026. The company focuses on developing gene therapies aimed at restoring vision for patients with inherited retinal diseases. Their pipeline includes several AAV-based programs targeting various genetic mutations.
Read more →Opus Genetics Announces Positive Low Dose Cohort 1 Data from Phase 1/2 Clinical Trial of OPGx-BEST1 and Successful FDA Type C Meeting with Potential Phase 3 Dosing in 2027
Opus Genetics announced positive results from the low-dose Cohort 1 of its Phase 1/2 clinical trial for OPGx-BEST1, showing significant improvements in visual function among participants. The FDA has aligned with the company on potential pivotal endpoints, paving the way for a Phase 3 trial expected to start in 2027. The trial demonstrated a favorable safety profile with no serious adverse events reported.
Read more →Opus Genetics to Present OPGx-BEST1 Cohort 1 Clinical Data in Investor Webcast and at Upcoming Leading Ophthalmology Conferences
Opus Genetics is set to present topline data from its Phase 1/2 OPGx-BEST1 gene therapy program during an investor conference call on September 9, 2026. The company will also showcase the full clinical dataset at several upcoming ophthalmology conferences. This initiative aims to address inherited retinal diseases, particularly BEST1-related conditions.
Read more →Opus Genetics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Opus Genetics, a clinical-stage biopharmaceutical company, has approved equity awards for three new non-executive employees as part of its 2021 Inducement Plan. The awards, totaling 310,000 stock options, are designed to incentivize employment and comply with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, promoting long-term commitment.
Read more →Opus Genetics Announces Financial Results for Second Quarter 2026 and Provides Corporate Update
Opus Genetics reported its financial results for Q2 2026, highlighting significant advancements in its gene therapy programs for inherited retinal diseases. The company completed enrollment in the LCA5 registrational trial and plans to initiate dosing in Q4 2026. With a cash runway extending into 2029, Opus is positioned to pursue multiple clinical studies and potential product approvals.
Read more →Opus Genetics Completes Patient Enrollment in Registrational Phase 3 Trial of OPGx-LCA5 for LCA5-Associated Inherited Retinal Disease
Opus Genetics has completed patient enrollment in its Phase 3 trial for OPGx-LCA5, a gene therapy targeting LCA5-associated inherited retinal disease. This milestone follows FDA alignment on the trial's design under the Rare Disease Evidence Principles program. The company anticipates topline efficacy data by the end of 2027 and aims to submit a Biologics License Application based on these results.
Read more →Opus Genetics Provides BEST1 Program Update with Detailed Timeline for OPGx-BEST1 Results
Opus Genetics has provided an update on its OPGx-BEST1 Phase 1/2 clinical trial targeting BEST-1 associated inherited retinal diseases. The company expects to release three-month topline data from Cohort 1 in September 2026 and present findings at the EURETINA Congress in October. The trial aims to evaluate the safety and efficacy of OPGx-BEST1, with potential for further development based on results.
Read more →Opus Genetics Announces FDA Alignment on Phase 3 Registrational Trial Design for OPGx-LCA5 in LCA5-Associated Inherited Retinal Disease
Opus Genetics has received FDA alignment on the design of its Phase 3 trial for OPGx-LCA5, a treatment for LCA5-associated inherited retinal disease. The trial will involve eight participants and aims to demonstrate significant improvement in retinal sensitivity. The company anticipates initiating dosing in Q4 2026 and may submit a BLA based on early efficacy data.
Read more →Opus Genetics Added to the Russell 3000®, Russell 2000® and Russell Microcap® Indexes
Opus Genetics, a clinical-stage biopharmaceutical company, announced its inclusion in the Russell 3000®, Russell 2000®, and Russell Microcap® indexes, effective June 29, 2026. This membership reflects the company's advancements in developing gene therapies for inherited retinal diseases. The CEO expressed optimism about the increased visibility and validation this brings to their strategic initiatives.
Read more →Opus Genetics Highlights Five Gene Therapy Programs Targeting Significant Unmet Need in Patients with Inherited Retinal Diseases
Opus Genetics is advancing five gene therapy programs aimed at treating inherited retinal diseases (IRDs), with four clinical data readouts expected by 2027. The company plans to initiate clinical testing for three new programs within the next 18 months, leveraging a strong cash runway that extends into 2029. The R&D Science Forum highlighted the potential for accelerated approvals and significant commercial opportunities across its pipeline.
Read more →Opus Genetics R&D Science Forum
The Opus Genetics R&D Science Forum was held on June 16, 2026, highlighting the company's forward-looking statements regarding its clinical trials and product pipeline. The presentation discussed risks associated with gene therapy product candidates and emphasized the uncertainties surrounding future operating performance. A panel of experts provided insights into various topics, including clinical strategy and disease prevalence, while addressing potential challenges in patient recruitment and regulatory approvals. The forum aimed to communicate Opus Genetics' vision amidst complex industry dynamics.
Read more →Opus Genetics to Host Virtual R&D Science Forum on Tuesday, June 16, 2026 Featuring Multiple Inherited Retinal Disease Experts
Opus Genetics will host a virtual R&D Science Forum on June 16, 2026, featuring experts discussing their gene therapy pipeline for inherited retinal diseases. The forum will cover three gene therapy programs targeting specific genetic mutations and present data from ongoing clinical programs. The event aims to highlight the company's progress and strategic plans in addressing vision loss.
Read more →Opus Genetics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - May 28, 2026
Opus Genetics, a clinical-stage biopharmaceutical company, announced the approval of equity awards for ten new non-executive employees as part of its 2021 Inducement Plan. The awards, totaling 698,000 stock options, are designed to incentivize and attract talent in the field of gene therapies for inherited retinal diseases. The options will vest over four years, aligning employee interests with company growth.
Read more →Opus Genetics to Present at the 2026 Jefferies Global Healthcare Conference
Opus Genetics, a clinical-stage biopharmaceutical company, will present at the 2026 Jefferies Global Healthcare Conference on June 3, 2026. The company focuses on gene therapies aimed at restoring vision for patients with inherited retinal diseases. Their pipeline includes several AAV-based programs targeting various genetic causes of retinal disorders.
Read more →Opus Genetics to Present at the RBC Capital Markets 2026 Global Healthcare Conference
Opus Genetics, a clinical-stage biopharmaceutical company, will present at the RBC Capital Markets 2026 Global Healthcare Conference on May 19, 2026. The presentation will highlight the company's efforts in developing gene therapies aimed at restoring vision for patients with inherited retinal diseases. Opus Genetics has a diverse pipeline of treatments targeting various genetic causes of retinal disorders.
Read more →Opus Genetics Announces Financial Results for First Quarter 2026 and Provides Corporate Update
Opus Genetics reported its financial results for Q1 2026 and provided a corporate update, highlighting positive advancements in its gene therapy programs. The company anticipates important data from its OPGx-BEST1 gene therapy study in September 2026 and is working to advance multiple programs into clinical testing over the next year. They have a strong financial position, with expected cash reserves sufficient to support operations through 2029, despite a significant increase in net loss during the quarter. The FDA's acceptance of their LCA5 program into the Rare Disease Evidence Principles program marks a notable regulatory achievement.
Read more →