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 (IRD) reported positive low‑dose Cohort 1 data from its Phase 1/2 BIRD‑1 trial of OPGx‑BEST1 in BEST1‑related retinal disease and alignment with FDA on a potential pivotal endpoint.
All five participants treated at 1.5 x 10⁹ vg/eye showed clinically meaningful visual function improvements, with structural retinal improvements in four. Best‑corrected visual acuity improved in 3 of 5 participants, low‑luminance visual acuity and contrast sensitivity each improved in 2 of 5, and 3 of 4 evaluable participants showed improved retinal sensitivity on microperimetry. No serious adverse events, dose‑limiting toxicities, intraocular inflammation, or notable lab/vital‑sign issues were observed; all treatment‑related adverse events were mild or moderate. The FDA agreed that ≥3 dB microperimetry improvement anchored to patient‑reported outcomes may serve as a pivotal endpoint, supporting planning for Phase 3 dosing in 2027. Cohort 2 at 4.5 x 10⁹ vg/eye has over‑enrolled to eight participants, with dosing completion expected in Q4 2026 and 3‑month topline data in Q2 2027. The company expects its cash runway to extend into 2029.
Opus Genetics (IRD) will present topline data from Cohort 1 of its Phase 1/2 OPGx-BEST1 gene therapy study during an investor conference call and webcast on Wednesday, September 9, 2026, at 8:00 a.m. ET.
The company will later share the full clinical dataset and additional analyses on visual function at multiple ophthalmology meetings, including Euretina Innovation Spotlight on September 30, 2026, Euretina 2026 on October 4, 2026, Retina in Rio on October 14, 2026, and a FLORetina presentation. These sessions will cover initial clinical results, structure-function correlations in BEST1-related retinopathy, and related gene augmentation findings in inherited retinal diseases.
Longeveron (NASDAQ: LGVN) appointed Nirav Jhaveri, CFA, as Chief Financial Officer, principal financial officer and principal accounting officer, joining the executive leadership team and succeeding Marie Washburn, who returns to her prior role as Corporate Controller.
According to Longeveron, Jhaveri brings over 25 years of experience in capital markets, corporate finance, business development and investor relations, including more than 15 years in the biotech sector and prior CFO roles at Opus Genetics (Nasdaq: IRD), Insilico Medicine (HKEX: 3696.HK) and Journey Medical (Nasdaq: DERM). The company also highlighted ongoing development of its stem cell therapy laromestrocel, with top-line data from a Phase 2b trial in HLHS expected in September 2026.
Opus Genetics (Nasdaq: IRD) reported that its Board’s Compensation Committee approved equity awards under the company’s 2021 Inducement Plan, as amended, as a material inducement to hiring three new non-executive employees. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4).
The equity awards consist of options to purchase an aggregate of 310,000 shares of Opus Genetics common stock, with an exercise price equal to the fair market value on the grant date. The options vest over four years: 25% on the one-year anniversary of each hire date, and the remaining 75% in quarterly installments thereafter, subject to possible acceleration or forfeiture under the applicable award agreements.
Opus Genetics (Nasdaq: IRD) reported second quarter 2026 license and collaborations revenue of $0.8 million, down from $2.9 million a year earlier, and a net loss of $8.1 million, or $0.08 basic and $0.14 diluted per share. R&D expenses rose to $11.2 million from $6.0 million, while G&A expenses were $6.0 million versus $5.8 million.
As of June 30, 2026, cash and cash equivalents were $88.8 million, and the company expects existing cash plus potential note funding to support operations into 2029. Opus Genetics completed Cohort 1 enrollment in its OPGx‑BEST1 Phase 1/2 trial with 3‑month topline data targeted for the second week of September 2026 and finalized the registrational Phase 3 OPGx‑LCA5 trial design with enrollment complete and dosing planned for Q4 2026. Additional gene therapy programs targeting RDH12, MERTK and RHO are expected to enter clinical testing between Q4 2026 and the second half of 2027.
Opus Genetics (Nasdaq: IRD) announced completion of patient enrollment in its registrational Phase 3 trial of OPGx-LCA5, an investigational gene therapy for LCA5-associated inherited retinal disease. The study design was developed with the U.S. FDA and aligned through the Rare Disease Evidence Principles (RDEP) program.
According to Opus Genetics, the one-time subretinal therapy is being evaluated for safety and efficacy using a six-month run-in period where patients serve as their own control. Dosing is expected to begin in Q4 2026, with topline six-month efficacy data targeted by year-end 2027, potentially supporting a Biologics License Application with 12-month durability data submitted during review. OPGx-LCA5 holds FDA Rare Pediatric Disease, Orphan Drug, and RMAT designations and may qualify for a Rare Pediatric Disease Priority Review Voucher upon approval.
Opus Genetics (Nasdaq: IRD) outlined a detailed timeline for its OPGx-BEST1 Phase 1/2 BIRD-1 trial in BEST1-associated inherited retinal diseases. Three-month topline data from five Cohort 1 participants are expected in the second week of September 2026, followed by data presentation at EURETINA in October.
Cohort 1 evaluates safety and tolerability at 1.5E9 vg/eye, with structural and functional endpoints, IDMC review, potential progression to a higher-dose Cohort 2, and possible pivotal expansion depending on subretinal fluid reduction. An investor relations quiet period will begin July 15, 2026.
Opus Genetics (Nasdaq: IRD) reported FDA alignment on the Phase 3 registrational trial design for OPGx-LCA5 in LCA5-associated inherited retinal disease. The eight-patient study includes a six-month run-in and targets a ≥7 dB retinal sensitivity improvement. Dosing is expected to start in 4Q 2026, with potential BLA submission based on six-month data.
Opus Genetics (Nasdaq: IRD), a clinical-stage gene therapy company for inherited retinal diseases, will join the Russell 3000®, Russell 2000® and Russell Microcap® Indexes when the U.S. market opens on June 29, 2026, following the June 2026 Russell indexes reconstitution.
Membership is based on market-capitalization rankings determined by FTSE Russell and lasts until the next semi-annual reconstitution. Russell US indexes are widely used as benchmarks, with about $12.2 trillion in assets benchmarked to them as of June 2025.
Opus Genetics (Nasdaq: IRD) outlined progress across five inherited retinal disease gene therapy programs and its commercial opportunity. Four clinical data readouts are expected in 2027, and three new programs (RDH12, MERTK, RHO) are planned to enter clinical testing within 12–18 months.
According to Opus Genetics, OPGx-LCA5 and OPGx-BEST1 are in Phase 1/2 trials, with pivotal LCA5 preparations underway. The company expects its cash runway to extend into 2029, supporting multiple clinical inflection points and potential product approvals.