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 (IRD) is a clinical-stage biotechnology company pioneering gene therapies and small molecule treatments for inherited retinal diseases. This page serves as the definitive source for verified updates on clinical trials, regulatory milestones, and therapeutic advancements in ocular medicine.
Investors and researchers will find comprehensive coverage of the company's AAV-based gene therapies targeting conditions like Leber congenital amaurosis, alongside non-genetic solutions such as Phentolamine Ophthalmic Solution. Our curated news collection provides essential insights into trial progressions, partnership announcements, and strategic developments.
Key updates include Phase 1/2 clinical trial results, FDA regulatory interactions, and innovations in retinal disease treatment approaches. All content is rigorously vetted to ensure accuracy and relevance for stakeholders monitoring advancements in ophthalmic biotechnology.
Bookmark this page for real-time updates on Opus Genetics' mission to address unmet needs in retinal degeneration through cutting-edge therapeutic development. Regularly refreshed content ensures you maintain strategic awareness of critical developments in this specialized medical sector.
Opus Genetics (Nasdaq: IRD) announced on Dec 16, 2025 that its Compensation Committee approved an inducement equity award under the 2021 Inducement Plan to a newly hired non-executive employee in compliance with Nasdaq Listing Rule 5635(c)(4). The award consists of options to purchase 50,000 shares of common stock with an exercise price equal to the fair market value on the grant date.
The options vest over four years: 25% at one year and the remaining 75% in quarterly installments, subject to acceleration or forfeiture per the award agreement.
Opus Genetics (Nasdaq: IRD) announced that CEO George Magrath, M.D. will present at the J.P. Morgan 2026 Healthcare Conference on Thursday, January 15, 2026 at 8:15 a.m. PT.
The company is a clinical-stage biopharmaceutical developer of gene therapies for inherited retinal diseases. A live and archived webcast will be available on Opus Genetics' investor website under Events.
Opus Genetics (Nasdaq: IRD) announced that an Independent Data Monitoring Committee issued a positive recommendation to continue the Phase 1/2 BEST1 (BIRD-1) trial after a pre-specified safety review.
The IDMC reviewed one-month safety data from the sentinel participant in the multi-center, adaptive, open-label, dose-exploring study of OPGx-BEST1 in Best disease and recommended advancing enrollment and dosing without modification, enabling dosing of the next four participants.
The company framed the outcome as an encouraging early safety signal that supports continued clinical evaluation of OPGx-BEST1 for Best disease.
Opus Genetics (Nasdaq: IRD) announced on Dec 2, 2025 that its Compensation Committee approved inducement equity awards under the company’s 2021 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The awards were granted to two new non-executive employees as options to purchase an aggregate of 124,000 shares of common stock. The options have an exercise price equal to the fair market value on the grant date and vest over four years: 25% at one year and the remaining 75% in quarterly installments, subject to acceleration or forfeiture as set in each award agreement.
Opus Genetics (Nasdaq: IRD) announced management will participate in two investor conferences in early December 2025. Ash Jayagopal, PhD, MBA, Chief Scientific and Development Officer, will appear in a fireside chat at BTIG 5th Annual Ophthalmology Day (Virtual) on December 1, 2025 at 1:00 p.m. ET. George Magrath, M.D., Chief Executive Officer, will appear in a fireside chat at Piper Sandler 37th Annual Healthcare Conference on December 2, 2025 at 10:00 a.m. ET in New York.
A link to the live and archived webcast for the Piper Sandler presentation is available on Opus Genetics' Investors > Events web page.
Opus Genetics (Nasdaq: IRD) announced dosing of the first participant in the OPGx-BEST1 Phase 1/2 gene therapy trial for Best disease on Nov 13, 2025. The one-time subretinal injection therapy targets BEST1-mutant retinal pigment epithelium cells. The trial is led by Dr. Mark Pennesi with surgical teams at Retina Consultants of Texas. Initial clinical data are expected in Q1 2026.
Opus Genetics (Nasdaq: IRD) reported Q3 2025 results and a corporate update on Nov 12, 2025. Key clinical highlights include positive 3-month pediatric and 18-month adult data from the OPGx-LCA5 Phase 1/2 trial and a successful FDA RMAT meeting that could enable an accelerated pathway. The company opened enrollment for OPGx-BEST1 and plans dosing for a Phase 3 LCA5 portion in H2 2026 with topline ~one year later.
Financially, cash was $30.8M at Sept 30, 2025 plus ~$23.0M raised post-quarter (cash >$50M) expected to fund operations into H2 2027; Q3 revenue was $3.1M and net loss was $17.5M (Q3 2025).
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.
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