IRD

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 Com

8-K - Opus Genetics, Inc. (0001228627) (Filer)

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 NEWSWIR

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. ET. A link to the live and archived webcast may be accessed on Opus Genetics’ website under the Investors section: Events. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness

4 - Opus Genetics, Inc. (0001228627) (Issuer)

4 - Opus Genetics, Inc. (0001228627) (Issuer)

8-K - Opus Genetics, Inc. (0001228627) (Filer)

DENVER, Sept. 10, 2026 (GLOBE NEWSWIRE) -- The biotech tape delivered a brutal reminder of one of the sector’s oldest rules: even a fundamentally strong company can get caught in the crossfire when a major drugmaker suffers a pipeline setback. Yesterday, a setback at Novartis (NYSE:NVS) sent ripples across the biotech space, pressuring companies whose own clinical and corporate announcements remained decidedly positive. The resulting selloff highlighted just how quickly investors can shift from company-specific fundamentals to broader sector risk. For smaller biotech names, that indiscriminate pressure can be painful, but it can also create potentially compelling rebound setups when posit

DENVER, Sept. 09, 2026 (GLOBE NEWSWIRE) -- (247marketnews.com) -- Across different corners of the market, the latest developments are putting investors’ attention back on tangible catalysts: NeOnc Technologies Holdings (NASDAQ:NTHI) is pairing fresh institutional capital with encouraging NEO100 clinical data; Opus Genetics (NASDAQ:IRD) is advancing OPGx-BEST1 toward potential pivotal development after positive early data and FDA feedback; bioAffinity Technologies (NASDAQ:BIAF) removed its Nasdaq compliance overhang while continuing to commercialize CyPath Lung; Tenon Medical (NASDAQ:TNON) eliminated roughly $5.16 million of convertible-note obligations ahead of maturity. NeOnc Raises $15

8-K - Opus Genetics, Inc. (0001228627) (Filer)

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

4 - Opus Genetics, Inc. (0001228627) (Issuer)

4 - Opus Genetics, Inc. (0001228627) (Issuer)

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 prevent blindness in patients with inherited retinal diseases (IRDs), today announced plans to present topline clinical data from Cohort 1 of its Phase 1/2 study of OPGx-BEST1 during an investor c

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 Company has appointed Nirav Jhaveri, CFA, to the Company’s executive leadership team in the role of Chief Financial Officer ("CFO"), principal financial officer and principal accounting officer. He succeeds Marie Washburn who stepped into the role following the retirement of the

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. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). The equity awards were granted in the form of options

EFFECT - Opus Genetics, Inc. (0001228627) (Filer)

SCHEDULE 13G/A - Opus Genetics, Inc. (0001228627) (Subject)

SCHEDULE 13G/A - Opus Genetics, Inc. (0001228627) (Subject)

S-3 - Opus Genetics, Inc. (0001228627) (Filer)

10-Q - Opus Genetics, Inc. (0001228627) (Filer)

8-K - Opus Genetics, Inc. (0001228627) (Filer)

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"), 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

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 restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the last patient has been enrolled in its registrational Phase 3 clinical trial evalu

TD Cowen initiated coverage of Opus Genetics with a rating of Buy