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. develops ophthalmic therapies for inherited retinal diseases as a clinical-stage biopharmaceutical company. Its pipeline includes AAV-based gene therapy programs led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RHO, CNGB1, RDH12, NMNAT1 and MERTK.
Company news commonly covers clinical and preclinical data, FDA regulatory interactions, scientific conference presentations, financing arrangements and annual financial results. Updates also include ophthalmic small-molecule development tied to Phentolamine Ophthalmic Solution 0.75% and collaboration activity related to that asset.
Opus Genetics (Nasdaq: IRD) secured a strategic financing facility with Oberland Capital that provides up to $155 million of primarily non-dilutive capital, including an $35 million initial tranche and a concurrent $5 million equity investment at $4.48 per share.
With ~$100 million pro forma cash, Opus says this extends runway into 2029 to complete pivotal OPGx-LCA5 and OPGx-BEST1 studies and to advance three earlier-stage programs toward clinical testing in 2026–2027.
Opus Genetics (Nasdaq: IRD) was named to Fast Company’s World’s Most Innovative Companies 2026 list in the Biotech category on March 24, 2026. The recognition highlights Opus Genetics’ patient-centered gene therapy work, including programs OPGx-BEST1 and OPGx-LCA5 targeting inherited retinal diseases.
The company emphasized its novel patient engagement approach and progress across a differentiated pipeline aimed at restoring vision and preventing blindness in ultra-rare IRDs.
Opus Genetics (Nasdaq: IRD) reported 2025 results and a corporate update on March 10, 2026. Key highlights include $45.1M cash at year-end and subsequent ~$25.0M private placement, implying $70.1M aggregate resources expected to fund operations into H1 2028.
Clinical progress: positive early safety and efficacy signals from OPGx-BEST1 (12-letter BCVA gain; 23% CST reduction), Phentolamine sNDA accepted with PDUFA date Oct 17, 2026, LYNX-3 topline H1 2026, OPGx-LCA5 pivotal dosing expected H2 2026, and funding secured for OPGx-MERTK development.
Opus Genetics (Nasdaq: IRD) announced management will present at three investor conferences in March 2026: Leerink Global Healthcare (Mar 10, 3:00 p.m. ET, Miami), Citizens Life Sciences (Mar 11, 2:50 p.m. ET, Miami), and RBC Capital Markets Global Ophthalmology (Mar 25, 11:45 a.m. ET, virtual).
Links to webcasts are available on the company's Investors > Events webpage.
Opus Genetics (Nasdaq: IRD) reported 3-month sentinel participant data for its Phase 1/2 OPGx-BEST1 gene therapy for BEST1-related retinal disease.
The treated 63-year-old participant showed no ocular inflammation, no treatment-related adverse events, and no dose-limiting toxicities. Efficacy signals included a 12-letter BCVA gain and 23% central subfield thickness (CST) reduction at three months. Full Cohort 1 data expected mid-year 2026.
Opus Genetics (Nasdaq: IRD) announced the FDA has accepted the supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a PDUFA goal date of October 17, 2026.
Phase 3 trials VEGA-2 and VEGA-3 met primary and all key secondary endpoints with no treatment-related serious adverse events. RYZUMVI is already approved in the U.S. for pharmacologic mydriasis, and Opus has a global U.S. commercialization license with Viatris. VEGA-3 data will be presented at ASCRS (April 2026) and ARVO (May 2026).
Opus Genetics (Nasdaq: IRD) agreed to a $25.0 million private placement of 7,374,632 shares of Series B Non‑Voting Convertible Preferred Stock at $3.39 per share. The preferred stock is expected to automatically convert one-for-one into common stock, subject to shareholder approval to increase authorized shares.
The financing is led by Adage Capital Management with participation from Trails Edge Capital Partners and Marshall Wace, is expected to close on February 18, 2026, and proceeds will fund gene therapy programs, working capital and general corporate purposes. Opus Genetics expects year-end 2025 pro forma cash of $70 million, which it says should fund operations into the first half of 2028.
Opus Genetics (Nasdaq: IRD) announced leadership participation in multiple ophthalmology and industry conferences in February 2026, presenting clinical and manufacturing updates.
Events include CCOI (Feb 3-4, Hong Kong), APAO (Feb 5-8, Hong Kong), Advanced Therapies Week (Feb 11, San Diego) and Macula Society (Feb 27, San Diego).
Opus Genetics (Nasdaq: IRD) launched a clinical trial for OPGx-MERTK, an AAV-based gene therapy for MERTK-related retinitis pigmentosa, with funding from Abu Dhabi’s Healthcare Research and Innovation Fund.
Cleveland Clinic Abu Dhabi will serve as the clinical site and clinical development activities are expected to commence in 2026. The program targets a disease affecting an estimated 60,000 patients worldwide and addresses an area with no approved treatments.
Opus Genetics (Nasdaq: IRD) reviewed 2025 progress and outlined 2026 catalysts across its ophthalmic gene therapy pipeline. Key near-term milestones include 3-month cohort data from the Phase 1/2 BEST1 trial expected mid-2026, initiation of pivotal Phase 3 dosing for LCA5 in the second half of 2026 after positive Phase 1/2 results, and an sNDA submission for a partnered presbyopia treatment with a regulatory decision anticipated by end of 2026. The company reported cash and cash equivalents of $30.8M as of Sept 30, 2025 and raised ~$23.0M in a subsequent registered direct offering, giving a cash runway into the second half of 2027 based on current plans. Multiple programs may qualify for Rare Pediatric Disease designation and other expedited pathways.