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Ocugen, Inc. (NASDAQ: OCGN) is a pioneering biotechnology company that focuses on discovering, developing, and commercializing novel gene and cell therapies, as well as vaccines aimed at improving health and offering hope to patients worldwide. The company's innovative efforts are concentrated on addressing rare and underserved ocular disorders.
Ocugen's core business revolves around a robust clinical pipeline which includes:
- OCU400: A groundbreaking gene-agnostic modifier gene therapy for retinitis pigmentosa (RP), currently in Phase 3 clinical trials. It leverages the nuclear hormone receptor gene NR2E3 to reset altered cellular gene networks and improve retinal health.
- OCU410: A potential one-time gene therapy for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). This therapy targets multiple pathways involved in the disease, including lipid metabolism, inflammation, oxidative stress, and the complement system.
- OCU410ST: Another modifier gene therapy in Phase 1/2 clinical trials for Stargardt disease, the most common form of inherited macular degeneration. It utilizes the AAV delivery platform for the RORA gene to regulate pathways linked to the disease.
Recent milestones include positive feedback from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the OCU400 Phase 3 liMeliGhT clinical trial, as well as the inclusion of Ocugen in the Russell 3000® Index, highlighting its market presence and growth potential.
Ocugen's commitment to innovative therapies is evident through its modifier gene therapy platforms designed to fulfill unmet medical needs related to inherited retinal diseases such as RP, Leber congenital amaurosis, and Stargardt disease. Additionally, the company is advancing research in infectious diseases to bolster public health and orthopedic diseases to meet unmet medical needs.
For the latest updates and detailed information about Ocugen, Inc., visit their official website at www.ocugen.com and follow them on X and LinkedIn.
Ocugen (NASDAQ: OCGN), a biotechnology company, will join the Russell 3000® Index, effective June 28, 2024, as per FTSE Russell's preliminary reconstruction. This inclusion highlights Ocugen's strong pipeline of gene and cell therapies, including the Phase 3 liMeliGhT trial of OCU400 for retinitis pigmentosa. The Russell 3000® Index tracks the performance of the largest 3,000 U.S. companies. Ocugen's addition could enhance its visibility among investors and broaden its shareholder base.
The Russell 3000® Index represents approximately 96% of the U.S. equity market and serves as a benchmark for $10.5 trillion in assets. Ocugen aims to leverage this inclusion to boost long-term shareholder value.
Ocugen announced that its Chief Scientific Officer, Arun Upadhyay, PhD, will present at the International Society for Cell & Gene Therapy's 2024 Annual Meeting in Vancouver, Canada. The presentation will focus on OCU400, a modifier gene therapy for retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA), targeting over 100 genetic mutations. The presentation will discuss safety and efficacy data from a Phase 1/2 clinical trial. The OCU400 Phase 3 liMeliGhT trial is progressing and aims for BLA and MAA approvals by 2026.
Ocugen has completed dosing in the second cohort of its Phase 1/2 GARDian clinical trial for the gene therapy OCU410ST, aimed at treating Stargardt disease. This milestone enables the company to advance to higher doses in the dose-escalation study. So far, six patients have been dosed, with three more to receive high doses in the final phase. The ongoing trial is crucial, as Stargardt disease lacks FDA-approved treatments, affecting around 100,000 people in the U.S. and Europe. Preliminary safety and efficacy data from Phase 1 will be shared soon, with a trial update expected in Q3 2024.
Ocugen (NASDAQ: OCGN) has reported its Q1 2024 financial results and provided a business update. The company is advancing its OCU400 gene therapy, with Phase 3 trials underway and aiming for 2026 BLA and MAA approvals. The gene therapy targets retinitis pigmentosa (RP), a condition affecting 300,000 people in the U.S. and Europe. Additionally, Ocugen is developing treatments for dAMD and Stargardt disease. Financially, Ocugen reported $26.4 million in cash and equivalents as of March 31, 2024, with a net loss per share of $0.05, an improvement from $0.08 in Q1 2023. Total operating expenses decreased from $18.5 million in Q1 2023 to $13.2 million in Q1 2024.
Ocugen, a biotechnology company, has announced the distribution of newly designated Series C Preferred Stock to holders of its common stock. Each outstanding share of common stock will receive one one-thousandth of a share of Series C Preferred Stock. The Series C Preferred Stock will vote together with the common stock on certain proposals and will have 1,000,000 votes per share. Shares not present at the shareholders meeting will be automatically redeemed with no voting power. The Series C Preferred Stock will be uncertificated and non-transferable except in connection with a transfer of common stock.
Ocugen, Inc. announced that its senior executives will present at two investor conferences in May 2024, highlighting the Company's gene and cell therapy clinical development progress, including the OCU400 Phase 3 clinical trial for retinitis pigmentosa. Dr. Shankar Musunuri and Dr. Huma Qamar will participate in the events.
Ocugen, Inc. will host a conference call on May 14, 2024, to discuss first quarter 2024 financial results and business updates. The company is focused on gene and cell therapies and vaccines. Attendees can join via dial-in numbers or webcast. A replay will be available on the investor site.
Ocugen, a biotechnology company, announced Dr. Arun Upadhyay, CSO, will present at the Retina World Congress on modifier gene therapy. The company's abstract on gene therapy for retinitis pigmentosa has been accepted. Their Phase 3 clinical trial for OCU400 is progressing towards BLA and MAA approval by 2026.
Ocugen Announces OCU400—Modifier Gene Therapy—Phase 1/2 Data Presentation at Retinal Cell and Gene Therapy Innovation Summit 2024
Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN) has announced that Benjamin Bakall, MD, PhD, Director of Clinical Research at Associated Retina Consultants and Clinical Assistant Professor at the University of Arizona, College of Medicine—Phoenix will present data from the OCU400 Phase 1/2 clinical trial at the Retinal Cell and Gene Therapy Innovation Summit being held on May 3, 2024 in Seattle, WA. The presentation will be about the safety and efficacy of Nuclear Hormone Receptor-Based Gene Modifier Therapy in Phase 1/2 Clinical Trials for Retinitis Pigmentosa.
The OCU400 Phase 3 liMeliGhT clinical trial is ongoing and is expected to meet the Company’s 2026 BLA and MAA approval targets. RP affects nearly 300,000 people in the U.S. and EU, and there is currently a significant unmet need for patients with this condition. Dr. Bakall believes that this approach can offer a new therapeutic option to address retinitis pigmentosa.
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