Opus Genetics, Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $366.9M
- Price
- $4.41
- % Change (Daily % change from the live per-ticker quote feed.)
- +0.68%
- Volume
- 1.8M
About
Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on ophthalmology. The company is dedicated to discovering and commercializing innovative therapies to address significant unmet medical needs in patients suffering from refractive and retinal eye disorders. Its portfolio includes Phentolamine Ophthalmic Solution, currently used to reverse pharmacologically induced mydriasis (pupil dilation). This solution is also advancing through Phase III clinical trials for the treatment of presbyopia and impaired vision in dim light or at night. A leading candidate in its retinal pipeline is APX3330, a small-molecule inhibitor targeting the reduction oxidation effector factor-1 protein. APX3330 has successfully completed Phase II clinical trials for diabetic retinopathy. Furthermore, Opus Genetics is developing APX2009 and APX2014, two preclinical product candidates also aimed at various retinal indications. Originally founded in 2018 as Ocuphire Pharma, Inc., the company maintains its headquarters in Farmington Hills, Michigan.
Quick stats
Shares outstanding83.2M
Computed float62.3M
Float / shares74.8%
Cash runway (months)19.9
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001228627
Websitehttps://opusgtx.com
AI Summary
AI-generated1/30
majorbullishclinical trial
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 reported positive 3- and 6-month Cohort 1 data from its Phase 1/2 BIRD-1 trial of OPGx-BEST1 in BEST1-related retinal diseases, with all five participants showing clinically meaningful visual function improvement and no serious adverse events or dose-limiting toxicities.
A successful August 2026 FDA Type C meeting produced alignment on a potential pivotal endpoint of at least 3 decibels of microperimetry improvement in five or more prespecified loci, paired with a patient-reported outcome, with Phase 3 participant dosing expected to begin in 2027.
The higher-dose Cohort 2 has been over-enrolled to eight participants, with dosing expected to complete in Q4 2026 and topline three-month data expected in Q2 2027; 6-month data for the three BVMD participants is also expected in Q2 2027.
New epidemiology from Triangle Insights Group estimates roughly 23,600 symptomatic U.S. BEST1 patients and about 45,400 globally -- a larger addressable population than previously estimated -- and management says cash runway extends into 2029, funding multiple clinical inflection points.
Red flags
- Interim, open-label data from only five participants with no control arm -- natural disease fluctuation or investigator bias cannot be excluded
- Company's own forward-looking caveats note interim results are subject to change materially as follow-up matures
- Clinical-stage small-cap with no approved products; the Phase 3 path still depends on higher-dose Cohort 2 safety and successful pivotal execution