Opus Genetics Stock Price, News & Analysis

Opus Genetics (Nasdaq: IRD) announced a registered direct offering to raise approximately $23 million in gross proceeds, led by Perceptive Advisors and Balyasny Asset Management with participation from Nantahala Capital.

The company will sell 3,827,751 common shares at $2.09 per share and issue pre-funded warrants to purchase up to 7,177,033 shares at $2.0899 each (exercise price $0.0001), immediately exercisable. Expected close date is November 7, 2025. Proceeds are targeted to advance the LCA5 and BEST-1 gene therapy programs and for working capital. Based on current plans, cash is expected to fund operations into the second half of 2027, excluding any proceeds from callable warrants or milestone payments.

Opus Genetics (Nasdaq: IRD) reported a successful Type B RMAT meeting with the FDA supporting advancement of OPGx-LCA5 toward a pivotal adaptive Phase 3 trial for LCA5-related Leber congenital amaurosis.

The FDA provided constructive feedback on CMC and pivotal trial design, acknowledged unmet need, and affirmed regulatory flexibility; Opus plans to seek the FDA’s new RDEP review. Six late-stage participants in Phase 1/2 showed clinically meaningful vision improvements. The company enrolled the first participant in a planned run-in period, expects dosing after validated commercial CMC in H2 2026, and topline data ~one year later. Recent $23M financing funds operations into H2 2027.

Opus Genetics (Nasdaq: IRD) announced on Nov 4, 2025 that its Compensation Committee approved inducement equity awards under the 2021 Inducement Plan for two new hires in compliance with Nasdaq Listing Rule 5635(c)(4).

The grants consist of stock options: 175,000 shares to James Farrell, Executive Director of Business Development, and 189,448 shares to a non-executive employee. Options have an exercise price equal to the fair market value on the grant date and vest over four years: 25% at the one-year milestone (based on hire or grant date as specified) with the remaining 75% vesting quarterly thereafter, subject to acceleration or forfeiture under each award agreement.

Opus Genetics (Nasdaq: IRD) was featured on Good Morning America on Nov 3, 2025 for its investigational gene therapy OPGx-LCA5 targeting LCA5-related inherited retinal disease. The segment highlighted participant Lindsey Rambo and described the therapy's approach of delivering a functional LCA5 gene to retinal cells to restore photoreceptor function and partial vision.

The story coincides with ongoing Phase 1/2 trials, multiple active clinical programs for LCA5 and BEST1, a newly activated site at the Retina Foundation of the Southwest, and support from RD Fund and Foundation Fighting Blindness.

Opus Genetics (Nasdaq: IRD) announced that Ash Jayagopal, PhD, MBA, Chief Scientific and Development Officer, will present a corporate update at Chardan's 9th Annual Genetic Medicines Conference on Tuesday, October 21, 2025 at 12:00 p.m. ET. The company noted a live and archived webcast will be available via the Opus Genetics investor website under Events.

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.