Opus Genetics Stock Price, News & Analysis

Opus Genetics (Nasdaq: IRD) has announced its participation in four major medical and industry conferences in October 2025, where it will present clinical results from its pipeline programs. The company will showcase data from two key programs: the OPGx-LCA5 gene therapy for Leber congenital amaurosis type 5 (LCA5) and Phentolamine Ophthalmic Solution 0.75% (POS).

The presentations will include three-month pediatric and 18-month adult clinical data from the Phase 1/2 trial of OPGx-LCA5, as well as pivotal Phase 3 data from the LYNX-2 trial in keratorefractive patients. The company will present at the Cell and Gene Meeting on the Mesa, Fierce Biotech Week, American Academy of Optometry Annual Meeting, and Eyecelerator @ American Academy of Ophthalmology.

Opus Genetics (NASDAQ:IRD) announced positive three-month data from the pediatric cohort of its Phase 1/2 clinical trial for OPGx-LCA5, a gene therapy targeting Leber congenital amaurosis type 5 (LCA5). The trial showed significant improvements in three pediatric participants aged 16-17, demonstrating enhanced cone-mediated vision and visual acuity.

Key results include an average 0.3 logMAR improvement in visual acuity among pediatric participants, with individual improvements ranging from 0.2 to 0.7 logMAR. All participants showed greater than one log unit improvement in cone sensitivity and better object identification in mobility tests. Adult participants maintained improvements through 18 months, suggesting treatment durability. The therapy has been well-tolerated with no serious adverse events.

Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases, has announced equity inducement grants for its new CFO and five non-executive employees.

The company granted new CFO Rob Gagnon options to purchase 250,000 shares and 200,000 restricted stock units (RSUs). Additionally, five non-executive employees received options to purchase an aggregate of 483,448 shares. The CFO's options and RSUs will begin vesting on September 2, 2026, while the non-executive employee options vest over four years with a one-year cliff.

Opus Genetics (Nasdaq: IRD) has initiated dosing in LYNX-3, its pivotal Phase 3 clinical trial for Phentolamine Ophthalmic Solution 0.75%. The trial aims to evaluate the treatment's efficacy in keratorefractive patients experiencing night driving impairment and reduced mesopic vision.

The trial, which received FDA Fast Track designation and is being conducted under Special Protocol Assessment (SPA), follows the successful LYNX-2 Phase 3 trial that reported positive topline results in June 2025. The drug is designed to moderately reduce pupil size in low-light conditions, potentially addressing common post-LASIK visual disturbances like glare, halos, and starbursts, for which no FDA-approved treatments currently exist.

Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases and small molecule therapies for ophthalmic disorders, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025.

CEO George Magrath, MD, and Chief Scientific and Development Officer Ash Jayagopal, Ph.D., MBA, will deliver a corporate update presentation, available on demand starting September 8, 2025 at 7:00 a.m. ET. The company also noted that replays from recent investor events, including a Nasdaq Spotlight interview and other presentations, are available on their website's Investors section.

Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases, has appointed Rob Gagnon as Chief Financial Officer. Gagnon brings over 20 years of financial and operational leadership experience, having raised more than $2 billion in capital throughout his career.

Gagnon joins from Remix Therapeutics, where he served as CFO, and previously held executive positions at Verastem Oncology, Harvard Bioscience, Clean Harbors, and Biogen. He holds an MBA from MIT Sloan School of Management and currently serves on multiple biotech company boards.

Opus Genetics (Nasdaq:IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases (IRDs), has announced its participation in four major scientific conferences in September 2025.

Key presentations include a discussion on gene and cell therapies at the Ophthalmology Futures Forum in Paris, one-year results from a Phase I/II study of OPGx-LCA5 at the International Symposium on Retinal Degeneration in Prague, and industry insights at the LSX World Congress in Boston. Dr. Sally Tucker and Dr. Ash Jayagopal will be among the key presenters sharing updates on the company's progress in retinal disease treatments.

Opus Genetics (Nasdaq: IRD) has received FDA clearance for its Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy targeting BEST1-related inherited retinal disease (IRD). The company plans to initiate a Phase 1/2 clinical trial in the second half of 2025.

The trial will evaluate a single subretinal injection of OPGx-BEST1 in patients with genetically confirmed BEST1-related IRD, focusing on safety, tolerability, and preliminary efficacy. This represents Opus's third ongoing clinical program, utilizing their proprietary AAV-based gene therapy platform to deliver functional BEST1 genes to retinal pigment epithelium cells.

Opus Genetics (NASDAQ:IRD) reported Q2 2025 financial results and significant pipeline progress. The company achieved key milestones including FDA RMAT designation for OPGx-LCA5 gene therapy, supported by positive 12-month Phase 1/2 data showing sustained vision improvements in adult patients. Their Phentolamine program met primary endpoints in two Phase 3 trials for presbyopia and night vision disturbances.

Financial highlights include $32.4M cash position funding operations into H2 2026, $2.9M in revenue (vs $1.1M in Q2 2024), and a net loss of $7.4M ($0.12 per share). The company secured non-dilutive funding up to $3.6M from patient advocacy groups to advance early-stage gene therapy programs.