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Opus Genetics, Inc.

IRDFDA catalysts, PDUFA dates & pipeline intelligence
$3.82
▼ -0.33 · -7.9%

Financials

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Total Assets
Total Liabilities
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D/E Ratio
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Quarterly Cash
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52W LOW $1.7052W HIGH $7.07
Volume
894.74 K
Value Traded
2.25 M
Short % Float
19.28%
Days to Cover
6.1
-0.52%Week
-20.91%1 Month
+24.03%3 Month
-26.96%6 Month
-7.19%5 Year
-100%All Time

Cash Data

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Key Stats

Market Cap
315.72 M
EPS (TTM)
-1.29
P/E Ratio
-
Ent. Value
262.18 M
Total Shares
82.65 M
Float Shares
67.48 M
Insiders
18.89%
Institutions
64.79%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
sNDA Submission
Phentolamine Ophthalmic Solution 0.75%
Presbyopia
NDASmall MoleculesOphthalmologic System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

IRD Catalyst Timeline

Dated clinical, regulatory and corporate events for Opus Genetics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Opus Genetics, Inc.

445Total events
24Upcoming
113Tier-1 (high impact)
2008 to 2029Coverage

Upcoming catalysts 2

T2First Patient Dosed
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OPGx-LCA5
T2Trial Initiation
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OPGx-LCA5

Event history 50

▲IND ClearanceOPGx-RDH12IND
FDA cleared IND for OPGx-RDH12 gene therapy in RDH12-LCA
RDH12-associated Leber congenital amaurosis (RDH12-LCA)source ↗
▲Supplemental ApprovalFDA Decision
FDA approves sNDA for phentolamine ophthalmic solution 0.75% (RYZUMVI) for presbyopia in adults
presbyopiasource ↗
▲Milestone PaymentCorporate
FDA presbyopia approval triggers milestone payment to Opus Genetics under Viatris licensing agreement
presbyopiasource ↗
▲Topline ReadoutOPGx-BEST1Clinical Data
OPGx-BEST1 low-dose Cohort 1 data showed improved retinal sensitivity in 75% of evaluable participants
BEST1-associated retinal diseasessource ↗
▲Oral PresentationOPGx-BEST1Presentation
OPGx-BEST1 Phase 1/2 BIRD-1 low-dose Cohort 1 data presented at Retina in Rio 2026
BEST1-associated retinal diseasessource ↗
▲Topline ReadoutOPGx-LCA5Clinical Data
OPGx-LCA5 Phase 1/2 data showed sustained visual acuity and light sensitivity improvements through 24 months in adults and six months in pediatric participants
Leber congenital amaurosis type 5 (LCA5)source ↗
▲Oral PresentationOPGx-LCA5Presentation
OPGx-LCA5 Phase 1/2/3 data presented at Retina in Rio 2026
Leber congenital amaurosis type 5 (LCA5)source ↗
▲Enrollment CompleteOPGx-BEST1Trial
OPGx-BEST1 Phase 1/2 BIRD-1 high-dose Cohort 2 completed enrollment with 11 participants
BEST1-associated retinal diseasessource ↗
▲Enrollment CompleteOPGx-LCA5Trial
OPGx-LCA5 Phase 3 trial natural history and treatment cohorts fully enrolled
Leber congenital amaurosis type 5 (LCA5)source ↗
▲Full ResultsOPGx-BEST1Clinical Data
OPGx-BEST1 Phase 1/2 BIRD-1 Cohort 1 data presented at Retina in Rio 2026
BEST1-associated retinal diseases (BVMD, ARB)source ↗
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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 %
2026-10-14OPGx-BEST1 Phase 1/2 data presentation Phase 1/2
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
4
Drugs Scored
rNPV / MCap
Top Drug
Top 21%
Micro Cap
(rank 139 of 658)
Percentile Rank
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-Q), to Jun 2026)
Showing 15 of 15 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Phentolamine Ophthalmic Solution Small moleculeNCT07140783Vision Loss NightPhase 3 RECRUITING 580Aug 1, 2027
OPGx-LCA5 Gene therapyNCT05616793LCA5Phase 1 RECRUITING 22Jun 15, 2028
OPGx-RDH12 Small moleculeNCT07681778Leber Congenital AmaurosisPhase 1 NOT YET_RECRUITING 10Jul 1, 2034
OPGx-BEST1 Gene therapyNCT07185256ARBPhase 1 RECRUITING 10Aug 1, 2030
Phentolamine Ophthalmic Solution Small moleculeMarketedNCT06542497PresbyopiaPhase 3 COMPLETED 569Jan 22, 2026
Phentolamine Ophthalmic Solution Small moleculeMarketedNCT03960866Open Angle GlaucomaPhase 2 COMPLETED 39Sep 11, 2019
Phentolamine Ophthalmic Solution Small moleculeMarketedNCT04004507Decrease in Night VisionPhase 2 COMPLETED 24Feb 1, 2008
Phentolamine Ophthalmic Solution Small moleculeMarketedNCT04024891MydriasisPhase 2 COMPLETED 32Sep 17, 2019
Phentolamine Ophthalmic Solution Small moleculeMarketedNCT01703559Night Vision ComplaintsPhase 2 COMPLETED 60Apr 30, 2012
APX3330 Small moleculeCompletedNCT04692688Diabetic RetinopathyPhase 2 COMPLETED 103Jan 25, 2023
Phentolamine 0.75% Small moleculeMarketedNCT06349759Mesopic VisionPhase 3 COMPLETED 200Feb 19, 2026
Phentolamine 0.75% Small moleculeMarketedNCT04638660Dim Light Vision DisturbancesPhase 3 COMPLETED 144May 19, 2022
Phentolamine 0.75% Small moleculeMarketedNCT05223478MydriasisPhase 3 COMPLETED 576Apr 28, 2022
Phentolamine Opthalmic 0.75% Small moleculeMarketedNCT05646719PresbyopiaPhase 3 COMPLETED 333Oct 11, 2023
Phentolamine 0.75% Small moleculeMarketedNCT04675151PresbyopiaPhase 2 COMPLETED 150Jun 30, 2021
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PTRS, rNPV, enrollment velocity, trial design quality and ML risk signals for every asset above.
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Clinical Trial Results

Readouts, endpoints and source filings for every IRD program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
OPGx-BEST1 BEST1-associated retinal diseasesPhase 1/22026-10-15improved retinal sensitivity in 75% of evaluable participantsRead MoreOpus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Foundation Fighting Blindness Retinal Degeneration FundDirector, See RemarksSell -556,000 3,236,171 held$4.96 09/30/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in IRD for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

IRD Institutional Ownership Trends

IRD Short Interest

Shares sold short, counted twice a month.

19.28%
Short % of Float
of tradable shares sold short
13.0M
Shares Sold Short
+3.5% vs prior count
6.1 High
Days to Cover
trading days of normal volume to buy every short share back
2.2M
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
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Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How IRD ranks across every disease it competes in

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See how IRD ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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IRD News

IRD
Oct 21, 2026
IRDFDA Updates
▼ -7.9%today

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 →
IRD
Oct 16, 2026
IRDFDA Updates

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 →
IRD
Oct 15, 2026
IRDPhases
▼ -5.2%on this newsshared move

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.

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IRD
Oct 13, 2026
IRDConferences/Events
▼ -8.6%on this newsshared move

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.

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IRD
Sep 9, 2026
IRDPhases
▲ +32%on this news

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.

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IRD
Sep 2, 2026
IRDConferences/Events
▲ +16.2%on this news

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.

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IRD
Aug 19, 2026
IRDGeneral

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.

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IRD
Aug 6, 2026
IRDGeneral

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.

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IRD
Aug 3, 2026
IRDPhases

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.

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IRD
Jul 9, 2026
IRDPhases

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.

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IRD
Jul 6, 2026
IRDPhases

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.

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IRD
Jun 26, 2026
IRDGeneral
▲ +7.5%on this news

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.

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IRD
Jun 16, 2026
IRDGeneral

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.

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IRD
Jun 16, 2026
IRDConferences/Events

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.

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IRD
Jun 2, 2026
IRDConferences/Events

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.

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IRD
May 29, 2026
IRDGeneral

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.

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IRD
May 27, 2026
IRDConferences/Events

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 →
IRD
May 13, 2026
IRDConferences/Events

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 →
IRD
May 12, 2026
IRDGeneral

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.

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About Opus Genetics, Inc.

Durham, NC 28 employees opusgtx.com
Headquarters8 DAVIS DRIVE, DURHAM, NC, 27713
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