Welcome to our dedicated page for Opus Genetics news (Ticker: IRD), a resource for investors and traders seeking the latest updates and insights on Opus Genetics stock.
Opus Genetics, Inc. (Nasdaq: IRD) is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), along with small-molecule therapies for other ophthalmic disorders. The IRD news feed for IRD on Stock Titan aggregates company-issued updates, press releases, and regulatory communications that describe the progress of these programs.
Readers following Opus Genetics news can expect coverage of clinical trial milestones for its lead gene therapy candidates, including OPGx-LCA5 for Leber congenital amaurosis type 5 and OPGx-BEST1 for BEST1-related retinal degeneration and Best disease. The company regularly reports on Phase 1/2 and planned pivotal trial activities, safety and efficacy observations, and feedback from the U.S. Food and Drug Administration, such as outcomes of Regenerative Medicine Advanced Therapy (RMAT) meetings and regulatory designations.
News items also highlight pipeline expansion and preclinical work in programs targeting genes such as RHO, CNGB1, RDH12, NMNAT1, and MERTK, as well as partnerships with patient advocacy groups that provide non-dilutive funding and community engagement in rare retinal diseases. In addition, Opus Genetics issues updates on its small-molecule program, Phentolamine Ophthalmic Solution 0.75%, including supplemental New Drug Application plans and Phase 3 trials in presbyopia and low-light visual disturbances following keratorefractive surgery.
Investors and observers can also find corporate and financing announcements, such as registered direct offerings, inducement equity grants under Nasdaq Listing Rule 5635(c)(4), and conference participation at healthcare and ophthalmology events. By reviewing the IRD news page, users can track how Opus Genetics describes the evolution of its ophthalmic gene therapy and drug development pipeline over time.
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.
Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases and small molecule therapies for ophthalmic disorders, has announced its participation in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference.
CEO George Magrath, M.D. will participate in a fireside chat that will be available on demand starting Wednesday, August 13, 2025 at 7:00 a.m. ET. Investors can access the webcast through the Events section of Opus Genetics' website.
Opus Genetics (Nasdaq: IRD) has announced a strategic partnership with the Global RDH12 Alliance to advance OPGx-RDH12, a gene therapy program targeting RDH12-associated Leber congenital amaurosis (RDH12-LCA), a rare inherited retinal disease causing early childhood blindness.
The Alliance, comprising advocacy groups 'RDH12 Fund for Sight' (US) and 'Eyes on the Future' (UK), will provide up to $1.6 million in funding. The partnership includes risk-sharing and performance-based milestones, with plans to file an Investigational New Drug (IND) application with the FDA by late 2025.
The collaboration aims to accelerate the development of this potential treatment for patients with RDH12 mutations, who typically experience visual acuity loss and retinal changes by age two.
Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases, has granted equity inducement awards to two new non-executive employees on June 30, 2025. The awards include 240,000 stock options at an exercise price of $0.94 per share and 150,000 restricted stock units (RSUs).
The stock options will vest over four years, with 25% vesting after one year and the remaining 75% vesting quarterly thereafter. The RSUs will vest in four equal annual installments. These awards were granted under the Company's 2021 Inducement Plan and approved by the Compensation Committee in compliance with Nasdaq Listing Rule 5635(c)(4).
Opus Genetics (NASDAQ:IRD) announced positive topline results from its VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% in treating presbyopia. The study met its primary endpoint with 27.2% of treated participants achieving ≥15-letter improvement in near vision compared to 11.5% on placebo (p<0.0001).
The trial enrolled 545 participants across 40 U.S. sites, demonstrating significant patient-reported benefits and consistent safety profile with no serious adverse events. Key secondary endpoints were also met, showing rapid onset with 20.6% achieving vision improvement within 1 hour on Day 1. The company plans to submit an FDA application in H2 2025.