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Opus Genetics, Inc. (NASDAQ:IRD) reported on September 9 that all five low-dose BIRD-1 participants showed clinically meaningful improvement on at least one visual-function measure after treatment with investigational gene therapy OPGx-BEST1. The open-label Phase 1/2 cohort included three participants with Best vitelliform macular dystrophy followed for three months and two with autosomal recessive bestrophinopathy followed […]
Healthcare stocks were lower late Wednesday afternoon with the NYSE Healthcare Index and the State S
Researchers observed structural improvements in the retina in four of five patients being evaluated in a Phase 1/2 study
Opus Genetics (NASDAQ:IRD) reported positive low-dose Cohort 1 data from its Phase 1/2 BIRD-1 trial of OPGx-BEST1, alongside FDA alignment on potential pivotal endpoints and a development path that could lead to Phase 3 participant dosing in 2027. Key Investor TakeawaysAll five low-dose participants showed clinically meaningful improvement in at least one measure of visual function, while four of five showed structural retinal improvements.
OPGx-BEST1 demonstrated a favorable safety and tolerability profile with no serious adverse events or dose-limiting toxicities observed All five participants demonstrated clinically meaningful improvement in visual function, with structural improvements observed in four participants FDA aligned on ≥3 decibels microperimetry improvement in conjunction with patient reported outcomes as a potential pivotal endpoint Clinically meaningful best-corrected visual acuity improvements in 3 of 5 participan
Topline data from Phase 1/2 Cohort 1 of OPGx-BEST1 gene therapy program to be presented during investor conference call and webcast on September 9 at 8:00 a.m. ET Full clinical dataset and additional analyses evaluating key measures of visual function to be presented at upcoming medical meetings RESEARCH TRIANGLE PARK, N.C., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (“Opus” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and
Opus Genetics Inc (NASDAQ:IRD) shares rose 5. 9% in pre-market trading ahead of the scheduled release of three-month topline data from Cohort 1 of its OPGx-BEST1 Phase 1/2 clinical trial.
Nirav Jhaveri, Chief Financial Officer Nirav Jhaveri, Chief Financial Officer Mr. Jhaveri has over 25 years of experience in capital markets, corporate finance, business development and investor relations, including more than 15 years in the biotech sector MIAMI, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the Com
RESEARCH TRIANGLE PARK, N.C., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs) (the “Company”), today announced that the Compensation Committee of its Board of Directors approved equity awards under the Company’s 2021 Inducement Plan, as amended, as a material inducement to employment to three non-executive employees w
Opus Genetics, Inc. (IRD) delivered earnings and revenue surprises of +6.67% and -75.03%, respectively, for the quarter ended June 2026. Do the numbers hold clues to what lies ahead for the stock?
OPGx-BEST1 Cohort 1 Topline Data Expected in Second Week of September 2026 Enrollment Completed in LCA5 Registrational Trial with Dosing Planned for Q4 2026 RDH12, MERTK and RHO Programs Advancing with Upcoming Initiation of Clinical Testing Cash Runway into 2029 Expected to Support Multiple Clinical Inflection Points and Opportunities for Priority Review Vouchers RESEARCH TRIANGLE PARK, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”),
Topline six-month efficacy data expected by end of 2027 Phase 3 study follows FDA alignment on registrational trial design through Rare Disease Evidence Principles (RDEP) program Opus Genetics may submit a BLA based on 6-month efficacy data, with 12-month durability data provided during review RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to
Cohort 1 Topline Data Expected in the Second Week of September 2026RESEARCH TRIANGLE PARK, N.C., July 09, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company”, “Opus Genetics” or “Opus”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today provided updates on its ongoing OPGx-BEST1 Phase 1/2 clinical trial (BIRD-1) targeting BEST-1 associated IRDs. Opus expects
Successful Type B RDEP Meeting confirms FDA alignment on pivotal Phase 3 study designFDA indicates Opus Genetics may submit a BLA based on 6-month efficacy data, with 12-month durability data provided during reviewCompany expects to initiate Phase 3 dosing in 4Q 2026 RESEARCH TRIANGLE PARK, N.C., July 06, 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
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