Welcome to our dedicated page for Ocugen news (Ticker: OCGN), a resource for investors and traders seeking the latest updates and insights on Ocugen stock.
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.
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Ocugen, Inc. completes dosing in the second cohort of the Phase 1/2 ArMaDa clinical trial for OCU410, a gene therapy for geographic atrophy in dry age-related macular degeneration. The therapy targets approximately 1 million affected individuals in the US.
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Ocugen, Inc. announced that Dr. Shankar Musunuri will participate in a fireside chat at the Emerging Growth Virtual Healthcare Equity Conference. The chat will focus on the Company's recent business and clinical development progress, including FDA clearance for a Phase 3 clinical trial for OCU400, a gene therapy for retinitis pigmentosa.
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Ocugen, Inc. announces positive EMA opinion on OCU400 Phase 3 clinical trial for retinitis pigmentosa, aligning with FDA clearance. EMA's review supports the trial's design and statistical analysis, paving the way for Marketing Authorization Application submission. OCU400, a gene therapy, targets RP patients with RHO gene mutations and gene agnostic mutations. The positive opinion from EMA streamlines the approval process, potentially reducing time and costs for EU marketing authorization, with OCU400 on track for BLA and MAA approvals by 2026.
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Ocugen, Inc. announces FDA clearance for Phase 3 clinical trial of OCU400 gene therapy for retinitis pigmentosa, a significant milestone in the treatment of RP patients. The trial includes 150 participants with a gene-agnostic approach and aims to address unmet medical needs in RP treatment.
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Ocugen, Inc. receives DSMB approval to proceed with medium dose cohort dosing in the Phase 1/2 ArMaDa clinical trial for OCU410, establishing low dose as safe and tolerable. No serious adverse events reported, marking a significant milestone in the clinical development of OCU410.
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Ocugen, Inc. announces alignment with FDA for broad retinitis pigmentosa indication in Phase 3 clinical trial of OCU400 gene therapy program. The company also received RMAT designation for OCU400. Ocugen provided a general business update for 2023 and highlighted progress on modifier gene therapy programs for blindness diseases. The Phase 1/2 study results for RP patients were recognized by the FDA. OCU410 and OCU410ST gene therapy programs for GA and Stargardt disease are enrolling patients. Ocugen's mucosal vaccine candidate, OCU500, was chosen for NIAID Project NextGen initiative. The Company's regenerative cell therapy platform, NeoCart, is on track for a Phase 3 trial. Financially, Ocugen plans to restate its financial statements for 2022 and 2023 but expects no impact on cash position or projections. Cash, cash equivalents, and investments totaled $39.5 million as of December 31, 2023. The company had 256.6 million shares of common stock outstanding as of that date.
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Ocugen, Inc. announces that the Data Safety and Monitoring Board (DSMB) has approved proceeding with the medium dose of OCU410ST in the OCU410ST clinical trial for Stargardt disease. The favorable safety and tolerability profile of OCU410ST allows for evaluation of higher doses, addressing the unmet medical need for Stargardt patients.
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Ocugen, a biotechnology company, will host a conference call to provide a business update with financials for 2023. The call will take place on April 2, 2024, at 8:30 a.m. ET. Dial-in numbers and webcast details are provided for participation.
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Ocugen, Inc. appoints Dr. Huma Qamar as Chief Medical Officer (CMO) to lead clinical development. Dr. Qamar's rich background in clinical research and expertise in various therapeutic areas positions Ocugen well for future success.
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Ocugen completes dosing in the first cohort of Phase 1/2 ArMaDa clinical trial for OCU410, a gene therapy candidate for geographic atrophy.
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FAQ
What is the current stock price of Ocugen (OCGN)?
The current stock price of Ocugen (OCGN) is $0.7743 as of December 20, 2024.
What is the market cap of Ocugen (OCGN)?
The market cap of Ocugen (OCGN) is approximately 223.7M.
What does Ocugen, Inc. specialize in?
Ocugen specializes in discovering, developing, and commercializing novel gene and cell therapies, as well as vaccines aimed at improving health and offering hope to patients worldwide.
What are Ocugen's key projects?
Ocugen's key projects include OCU400 for retinitis pigmentosa, OCU410 for geographic atrophy, and OCU410ST for Stargardt disease. These therapies focus on modifying gene functions to treat retinal diseases.
What recent achievements has Ocugen accomplished?
Recent achievements include EMA and FDA clearance for the OCU400 Phase 3 clinical trial and inclusion in the Russell 3000® Index, signifying its market relevance and growth potential.
How does OCU400 work?
OCU400 is a gene-agnostic modifier gene therapy that uses the NR2E3 gene to reset altered cellular gene networks, aiming to improve retinal health in patients with retinitis pigmentosa.
What is the significance of Ocugen's modifier gene therapy platform?
Ocugen's modifier gene therapy platform is designed to treat multiple retinal diseases with a single product by addressing broader genetic conditions, offering hope to patients with complex inherited retinal disorders.
What are the target conditions for OCU410?
OCU410 targets geographic atrophy (GA), an advanced stage of dry age-related macular degeneration, by addressing multiple pathways involved in the disease such as lipid metabolism, inflammation, and oxidative stress.
How does OCU410ST aim to treat Stargardt disease?
OCU410ST uses the RORA gene delivered via an AAV platform to regulate pathways linked to Stargardt disease, targeting factors like oxidative stress and inflammation to preserve photoreceptor cells in the retina.
What is the impact of Ocugen's inclusion in the Russell 3000® Index?
Inclusion in the Russell 3000® Index enhances Ocugen's visibility within the investment community, supports long-term shareholder value, and broadens its shareholder base.
What steps has Ocugen taken to ensure the success of its clinical therapy programs?
Ocugen has received regulatory clearances for pivotal clinical trials, engaged in continuous safety and efficacy assessments, and is leveraging strategic partnerships to support its entire pipeline.
Where can I learn more about Ocugen's latest news and developments?
For the latest news and updates about Ocugen, visit their official website at www.ocugen.com and follow them on X and LinkedIn.
Ocugen, Inc.
Nasdaq:OCGN
OCGN Rankings
OCGN Stock Data
223.70M
287.21M
1.41%
27.53%
18.67%
Biotechnology
Biological Products, (no Disgnostic Substances)
United States of America
MALVERN