Opus Genetics

IRD

時価総額 $3.19億

FDA expands the approved use of phentolamine ophthalmic solution 0.75% to include age-related near vision impairment, which affects millions of adults in the United States Approval supported by positive results from pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary efficacy endpoints RESEARCH TRIANGLE PARK, N.C., Oct. 16, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults.

OPGx-BEST1 showed improved retinal sensitivity in 75% of evaluable participants in the initial low-dose Cohort 1 of the Company's Phase 1/2 clinical trial, supporting further clinical development New BEST1 data analyses link retinal structure to visual function, enabling focus on regions most likely to respond to treatment OPGx-LCA5 demonstrated sustained improvements in visual acuity and light sensitivity through 24 months in adults, with encouraging results in pediatric participants through six months in the Company's Phase 1/2/3 clinical trial Phase 3 clinical trial dosing for OPGx-LCA5 expected in the fourth quarter of 2026 RESEARCH TRIANGLE PARK, N.C., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), presented clinical findings from its OPGx-BEST1 and OPGx-LCA5 gene therapy programs at Retina in Rio 2026 in Rio de Janeiro, Brazil.

RESEARCH TRIANGLE PARK, N.C., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), announced today that management will present at the Chardan Annual Healthcare Conference on Tuesday, October 20, 2026 at 10:00 a.m.

Opus Genetics receives a Buy rating following >30% stock surge on positive Phase 1/2 data for OPGx-BEST1 in BEST1-related retinal diseases. OPGx-BEST1 showed clinically meaningful visual improvements and strong safety in all Cohort 1 patients, with greater gains in less advanced disease. IRD's pipeline targets large, underserved markets with no approved therapies; cash runway extends into 2029, supporting ongoing pivotal studies.

Opus Genetics, Inc. (IRD) Discusses Topline Results From Cohort 1 of BEST1 Phase I/II Gene Therapy Trial Transcript

Opus Genetics, Inc. (NASDAQ:IRD) stock is surging on Wednesday after the company reported positive three- and six-month results from the low-dose first cohort of its Phase 1/2 BIRD-1 trial of OPGx-BEST1.

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 participants and retinal sensitivity improvements on microperimetry observed in 3 of 4 evaluable participants Cohort 2 over-enrolled, with dosing expected to be completed in Q4 2026 and topline 3-month data expected in Q2 2027 Cash runway into 2029 expected to support multiple clinical inflection points and opportunities for priority review vouchers Webcast and conference call today at 8:00 a.m. ET with management and Key Opinion Leader and retinal specialist, Mark Pennesi, M.D.

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.

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 who were not previously employees or directors of the Company.

Opus Genetics, Inc. (IRD) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.15. This compares to a loss of $0.12 per share a year ago.