LCA (Landcadia Holdings IV, Inc.) is no longer actively trading.
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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 evaluating OPGx-LCA5, the Company's investigational gene therapy for LCA5-associated inherited retinal disease.

Successful Type B RDEP Meeting confirms FDA alignment on pivotal Phase 3 study design FDA indicates Opus Genetics may submit a BLA based on 6-month efficacy data, with 12-month durability data provided during review Company 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 blindness in patients with inherited retinal diseases (IRDs), today announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) in a Type B Rare Disease Evidence Principles (RDEP) meeting on the design of its registrational Phase 3 clinical trial evaluating OPGx-LCA5 for LCA5-associated IRD, an early-onset severe inherited retinal dystrophy.

Vontier (NYSE: VNT), a leading global provider of critical technologies and solutions to connect, manage and scale the mobility ecosystem, today released its 2

RESEARCH TRIANGLE PARK, N.C., May 04, 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 its investigational LCA5 gene therapy program, OPGx-LCA5, has been accepted into the U.S. Food and Drug Administration's (FDA) Rare Disease Evidence Principles (RDEP) program.

Opus Genetics targets inherited retinal diseases with one-dose AAV gene augmentations. Its lead candidate is OPGx-LCA5, which is moving into Phase 3 enrollment. Interestingly, OPGx-LCA5's Phase 1/2 showed encouraging safety and functional vision improvements and already has important FDA designations. Similarly, OPGx-BEST1 is an early-stage but promising program with supportive preclinical signals. Its 2026 readouts could be a meaningful catalyst.

EL SEGUNDO, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) -- With a mission to positively impact human health, climate change, constraints on natural resources and animal welfare, Beyond Meat, Inc. (NASDAQ: BYND), a leader in plant-based meat, today released its 2024 Corporate Responsibility Report and its Beyond Burger IV Life Cycle Assessment (LCA) study, and announced its first-time submission to CDP (formerly the Carbon Disclosure Project).

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides the potential for an accelerated regulatory pathway to approval of OPGx-LCA5 First participant enrolled in run-in period for planned adaptive Phase 3 trial Company intends to apply for the FDA's new Rare Disease Evidence Principles (RDEP) review process OPGx-LCA5 has the potential to be the first gene therapy and one-time treatment for Leber congenital amaurosis (LCA) type 5 Recent $23 million financing led by Perceptive Advisors and Balyasny Asset Management to advance LCA5 and BEST1 programs and fund current operating plans into second half of 2027 RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies for inherited retinal diseases (IRDs) and small-molecule therapies for other ophthalmic disorders, today announced the successful completion of a Type B Regenerative Medicine Advanced Therapy (RMAT) meeting with the U.S. Food and Drug Administration (FDA) regarding OPGx-LCA5, its gene therapy candidate for Leber congenital amaurosis (LCA) caused by mutations in the LCA5 gene.

Pediatric participants demonstrated large gains in cone-mediated vision; therapy remains well tolerated with no ocular serious adverse events or dose-limiting toxicities Lasting, durable responses observed out to 18 months in adult participants Expected FDA Meeting in Q4 2025 Management to Host Webcast and Conference Call Today at 8:30 A.M. ET RESEARCH TRIANGLE PARK, N.C.
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