IRD

Opus Genetics Virtual R&D Science Forum Scheduled for Tuesday, June 16, 2026, at 10:00 am ET Upcoming Data Readout for Cohort 1 of OPGx-BEST1 Gene Therapy Study Expected in September 2026 LCA5 Accepted to FDA’s Rare Disease Evidence Principles (RDEP) Program and Enrolling Pivotal Trial RDH12, MERTK and RHO Programs Expected to Advance to Clinical Testing in the Next 12 Months Cash Runway into 2029 Expected to Support Multiple Clinical Inflection Points, Potential Product Approvals and Opportunities for Priority Review Vouchers RESEARCH TRIANGLE PARK, N.C., May 12, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. “With encouraging momentum across both our LCA5 and BEST1 gene therapy programs, Opus Genetics is entering a defining stretch where we believe our precision targeted approach can reshape what’s possible for patients with inherited retinal diseases,” said George Magrath, M.D., Chief Executive Officer of Opus Genetics. “Our upcoming BEST1 Cohort 1 clinical data and June R&D Science Forum will provide key opportunities to showcase the depth and maturity of our science and pipeline. Backed by a strong balance sheet and disciplined capital strategy, we are well-positioned to advance our lead programs toward pivotal trials, and accelerate our earlier‑stage RDH12, MERTK, and RHO programs into the clinic.” Pipeline Updates Research & Development (R&D) Science Forum Opus Genetics plans to host an R&D Science Forum on Tuesday, June 16, 2026, from 10:00 am – 12:00 pm ET, with management and key opinion leaders (KOLs) highlighting earlier-stage gene therapy programs entering clinical testing and IRD global market opportunities. Registration for the event will be available on the Events page of the Opus Genetics website. OPGx-BEST1 Enrollment completed in Cohort 1 of the Phase 1/2 trial (BIRD-1) including participants with both dominant and recessive forms of BEST disease, with the final participant scheduled for dosing this month. Baseline demographics were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeti...

Certara, Inc. (CERT) came out with quarterly earnings of $0.09 per share, missing the Zacks Consensus Estimate of $0.11 per share. This compares to earnings of $0.14 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -20.57%. A quarter ago, it was expected that this company would post earnings of $0.11 per share when it actually produced earnings of $0.09, delivering a surprise of -18.18%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Certara, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $106.92 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 1.22%. This compares to year-ago revenues of $106 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Certara shares have lost about 28.4% since the beginning of the year versus the S&P 500's gain of 8.1%. While Certara has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Certara was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) st...

- Favorable early safety and initial efficacy data from BEST1 program highlighted at premier gathering of global retinal experts with additional data expected mid-year 2026 - - Reauthorization of FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program provides opportunity for Opus’ deep pipeline in rare inherited retinal diseases - - FDA Prescription Drug User Fee Act (PDUFA) date in October 2026 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia - - Funding from prominent healthcare investors expected to extend cash runway into 2028 - RESEARCH TRIANGLE PARK, N.C., March 10, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the year ended December 31, 2025, and provided a corporate update. “We are delivering a steady cadence of data and milestones across our pipeline,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “With positive clinical results from both our BEST1 and LCA5 gene therapy programs, new funding for our MERTK program and an upcoming FDA PDUFA date for Phentolamine Ophthalmic Solution 0.75% in presbyopia, we are advancing therapies with both scientific promise and compelling commercial potential. The reauthorization of the U.S. Rare Pediatric Disease Priority Review Voucher program further strengthens our work, reinforcing long‑term incentives that support sustainable investment in rare gene therapy development. With multiple catalysts ahead and a capital‑efficient operating model, we believe Opus is positioned to create significant long‑term value for shareholders.” Pipeline Updates OPGx-BEST1 – Gene Therapy for BEST1-Related IRD Recruitment is ongoing at multiple U.S. sites with two participants treated to date in the Phase 1/2 trial (BIRD-1) that includes patients with both dominant and recessive forms of BEST disease. Positive initial three-month data from the first (sentinel) participant presented at Macula Society The data demonstrated that OPGx-BEST1 was well tolerated with no ocular inflammation, no ocular or treatment-related adverse events, and no dose limiting toxicities observed to date. Early signals of functional vision improvement were o...

- Positive 3-month pediatric and 18-month adult clinical data from OPGx-LCA5 Phase 1/2 trial support the potential for restoring cone-mediated vision - - Successful FDA RMAT meeting provides the potential for an accelerated regulatory pathway to approval for OPGx-LCA5 - - OPGx-BEST1 gene therapy program underway with recruitment ongoing in Phase 1/2 trial for the treatment of BEST1 disease - - Supplemental New Drug Application submission planned by year-end 2025 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia - - Strengthened capital position from recent equity offering and non-dilutive funding from patient advocacy groups - RESEARCH TRIANGLE PARK, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. “We have taken critical steps in advancing our pipeline, including the positive data and successful outcome of our recent FDA meeting regarding our LCA5 program and the opening of recruitment in our BEST1 Phase 1/2 clinical trial,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “We look forward to continuing this momentum into next year, when we expect multiple data readouts across several programs. The financing we recently completed reinforces the strong support from existing shareholders and new prominent healthcare investors and provides us with financial resources to expedite the path toward multiple approvals.” Pipeline Updates OPGx-LCA5 – Gene Therapy for Leber Congenital Amaurosis (LCA) In September 2025, positive data was reported from the six participants treated to date in an open-label, Phase 1/2 clinical trial. Large gains in cone-mediated vision with improvements across multiple measures of visual function were observed in the three pediatric participants treated over three months. In the three adult participants, responses have been observed out to 18 months, underscoring the potential durability of the treatment response. OPGx-LCA5 has been well tolerated with no ocular serious adverse events or dose-limiting toxicities to date. Successful completion of a Type B Regenerativ...

The market expects Opus Genetics, Inc. (IRD) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +51.7%. Revenues are expected to be $2.77 million, down 28.4% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 4.55% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A po...

It's been a pretty great week for Opus Genetics, Inc. (NASDAQ:IRD) shareholders, with its shares surging 12% to US$1.20 in the week since its latest second-quarter results. Revenues came in at US$2.9m, a whole 32% below what the analysts were forecasting. Losses were a (relative) bright spot by comparison, with a per-share (statutory) loss of US$0.12 substantially smaller than what was expected. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Opus Genetics after the latest results. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Taking into account the latest results, the current consensus, from the four analysts covering Opus Genetics, is for revenues of US$14.3m in 2025. This implies a measurable 7.4% reduction in Opus Genetics' revenue over the past 12 months. Losses are predicted to fall substantially, shrinking 50% to US$0.49. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$17.3m and losses of US$0.84 per share in 2025. So there's been quite a change-up of views after the recent consensus updates, withthe analysts making a serious cut to their revenue forecasts while also reducing the estimated losses the business will incur. See our latest analysis for Opus Genetics The analysts have cut their price target 11% to US$6.00per share, suggesting that the declining revenue was a more crucial indicator than the forecast reduction in losses. The consensus price target is just an average of individual analyst targets, so - it could be handy to see how wide the range of underlying estimates is. Currently, the most bullish analyst values Opus Genetics at US$8.00 per share, while the most bearish prices it at US$5.00. Analysts definitely have varying views on the business, but the spread of estimates is not wide enough in our view to suggest that extreme outcomes could await Opus Genetics shareholders. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. We would h...

- Positive 12-month Phase 1/2 clinical data in adult cohort and early pediatric clinical data support potential for meaningful vision restoration with OPGx-LCA5 - - FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5 - - Positive topline results reported from VEGA-3 and LYNX-2 Phase 3 trials with Phentolamine Ophthalmic Solution 0.75% - - OPGx-BEST1 on track to enter Phase 1/2 trial in H2 2025 for the treatment of bestrophin-1 related inherited retinal disease - - Non-dilutive funding from patient advocacy groups secured to advance multiple early-stage gene therapy programs - RESEARCH TRIANGLE PARK, N.C., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. “We’ve made significant progress across our pipeline, with multiple clinical and regulatory milestones achieved this quarter,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “Receiving RMAT designation for our OPGx-LCA5 program underscores the strength of our clinical data and the urgent need for effective gene therapies to treat inherited retinal diseases. We are encouraged by the sustained functional vision improvements observed in adult patients in our clinical trial to date and the early signs of efficacy in the pediatric cohort. In parallel, our advancement of OPGx-BEST1 toward the clinic and the nomination of two additional development candidates in partnership with the Retinal Degeneration Fund and the Global RDH12 Alliance highlight the breadth of our IRD pipeline.” “Beyond gene therapy, the positive readouts from our two Phase 3 Phentolamine trials represent a major step toward our goal of bringing a new treatment option to millions of patients living with vision challenges. With several upcoming key milestones, including new clinical data, a supplemental New Drug Application (sNDA) submission, and the launch of a pivotal study, we remain focused on execution to deliver transformative treatments to patients with significant unmet needs,” Dr. Magrath concluded. Pipeline Updates OPGx-LCA5 – Gene Therapy for...

It's been a good week for Opus Genetics, Inc. (NASDAQ:IRD) shareholders, because the company has just released its latest quarterly results, and the shares gained 7.7% to US$1.02. Revenues of US$4.4m crushed expectations, although expenses increased commensurately, with statutory losses hitting US$0.24 per share, -17% above what the analysts expected. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. We've discovered 4 warning signs about Opus Genetics. View them for free. Taking into account the latest results, the current consensus from Opus Genetics' three analysts is for revenues of US$15.4m in 2025. This would reflect a decent 13% increase on its revenue over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 39% to US$0.78. Before this latest report, the consensus had been expecting revenues of US$13.3m and US$0.81 per share in losses. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. Check out our latest analysis for Opus Genetics Yet despite these upgrades, the analysts cut their price target 31% to US$7.33, implicitly signalling that the ongoing losses are likely to weigh negatively on Opus Genetics' valuation. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. Currently, the most bullish analyst values Opus Genetics at US$8.00 per share, while the most bearish prices it at US$6.00. With such a narrow range of valuations, the analysts apparently share similar views on what they think the business is worth. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. We wo...

Revenue: US$4.37m (up 155% from 1Q 2024). Net loss: US$8.19m (loss widened by 15% from 1Q 2024). US$0.24 loss per share. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 34%. Earnings per share (EPS) missed analyst estimates by 17%. Looking ahead, revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 7.7% from a week ago. What about risks? Every company has them, and we've spotted 4 warning signs for Opus Genetics (of which 1 can't be ignored!) you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

ARVO presentation highlights 12-month results from Phase 1/2 study that support potential of OPGx-LCA5 gene therapy to restore meaningful vision Pediatric cohort of LCA5 study ongoing with initial multi-patient data anticipated in Q3 2025 OPGx-BEST1 on track for IND filing and initiation of Phase 1/2 trial with early data expected in Q1 2026 Leading healthcare investors provide funding to deliver on key milestones RESEARCH TRIANGLE PARK, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biopharmaceutical company developing important new therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders (“Opus” or the “Company”), today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. “Opus is off to a strong start in 2025, with progress across our two product portfolios – the inherited retinal disease platform and the phentolamine eye drop franchise,” said George Magrath, M.D., Chief Executive Officer. “We reported positive 12-month data from the Phase 1/2 trial of OPGx-LCA5 for the treatment of Leber congenital amaurosis 5 (LCA5), an inherited disease which leads to severe vision loss from infancy. The evidence of durable efficacy in adult patients is very encouraging, with the treatment benefits previously seen at 6 months now sustained out to one year. We are now enrolling pediatric patients and are encouraged by the meaningful improvement in visual function and early safety profile observed in the first of these patients at one month.” Dr. Magrath continued, “We believe that the initial success with our lead IRD program, OPGx-LCA5, has the potential to translate to the rest of our pipeline, which includes gene therapy candidates for six additional IRDs. We plan to initiate a Phase 1/2 study with our BEST-1 program later this year with early data expected in the first quarter of 2026. “In the phentolamine eye drop pipeline, we look forward to near-term clinical data readouts from the Phase 3 data trials in dim light vision disturbances and in presbyopia. We ended the first quarter with a strong cash position, having completed a successful financing with leading institutional healthcare investors who share our confidence in the Company’s strategic direction,” concluded Dr. Magrath. Strategic Highlights Opus’s pipeline incl...

Improvements in subjective and objective measures of efficacy observed at six months persisted for one year in patients with severe vision impairment from inherited retinal degeneration due to mutations in the LCA5 gene Administration of OPGx-LCA5 by subretinal injection was well tolerated by study participants RESEARCH TRIANGLE PARK, N.C., May 05, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders (“Opus” or the “Company”), today announced one-year results from adult patients treated in the ongoing Phase 1/2 Study of its lead gene therapy candidate OPGx-LCA5. These results were presented yesterday at the 2025 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), taking place May 4 – 7, 2025 in Salt Lake City, Utah. The presentation, entitled “Recovery of Cone-Mediated Vision in a Severe Ciliopathy after Gene Augmentation: One Year Results of a Phase I/II Trial for LCA5-LCA,” was delivered by Dr. Tomas Aleman of the Scheie Eye Institute, University of Pennsylvania. “The preliminary data emerging from this Phase 1/2 study of OPGx-LCA5 are very encouraging. We are pleased to see evidence of durable efficacy, with the treatment benefits observed at six months being sustained out to one year,” said Dr. Aleman. “Unquestionable gains in cone-mediated vision (daytime) confirmed one year after treatment have been associated with improvements in patients’ reading vision and ability to recognize objects, which are meaningful to these patients with severely impaired visual function. These findings support continued development of this gene therapy, which offers potentially groundbreaking opportunities, as we look forward to enrolling additional patients into the study.” George Magrath, M.D., Chief Executive Officer of Opus Genetics, added, “Presentation of the 12-month data at ARVO underscores the growing interest in this program, and if approved, OPGx-LCA5 could potentially offer a life changing treatment for these patients. The new data, while in a limited number of adults patients, give us even more conviction that our initial success with OPGx-LCA5 has the potential to translate to the rest of our pipeline, which contains gene therapy treatments for six...

Celebrations may be in order for Opus Genetics, Inc. (NASDAQ:IRD) shareholders, with the analysts delivering a significant upgrade to their statutory estimates for the company. The analysts greatly increased their revenue estimates, suggesting a stark improvement in business fundamentals. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Following the upgrade, the current consensus from Opus Genetics' three analysts is for revenues of US$17m in 2025 which - if met - would reflect a substantial 57% increase on its sales over the past 12 months. The loss per share is anticipated to greatly reduce in the near future, narrowing 37% to US$0.80. Yet prior to the latest estimates, the analysts had been forecasting revenues of US$13m and losses of US$0.99 per share in 2025. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. View our latest analysis for Opus Genetics Despite these upgrades, the analysts have not made any major changes to their price target of US$10.33, implying that their latest estimates don't have a long term impact on what they think the stock is worth. Looking at the bigger picture now, one of the ways we can make sense of these forecasts is to see how they measure up against both past performance and industry growth estimates. We can infer from the latest estimates that forecasts expect a continuation of Opus Genetics'historical trends, as the 57% annualised revenue growth to the end of 2025 is roughly in line with the 52% annual revenue growth over the past five years. By contrast, our data suggests that other companies (with analyst coverage) in a similar industry are forecast to see their revenues grow 8.2% per year. So it's pretty clear that Opus Genetics is forecast to grow substantially faster than its industry. The highlight for us was that the consensus reduced its estimated losses this year, perhaps suggesting Opus Genetics is moving incrementally towards profitability. Fortunately, analysts also upgraded their revenue estimates, and our data indicates sales are expected to perform better than the wider market. The lack of change in the price target is puzzling, but with a serious upgrade t...