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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, Inc. (NASDAQ: OCGN) reported its first quarter 2022 results, indicating a cash position of $129.9 million, up from $95.1 million in Q4 2021. Significant milestones include the Phase 1/2 trial for OCU400, with the first patient dosed in March and a second in May. The company expanded its COVAXIN™ marketing rights to cover all of North America, including Mexico. R&D expenses rose to $7.9 million from $2.9 million year-over-year. The net loss was $0.09 per share, compared to $0.04 last year. A conference call is scheduled for further discussion.
Ocugen, Inc. (NASDAQ: OCGN) announced a conference call scheduled for May 6, 2022, at 8:30 a.m. ET, to discuss its first quarter 2022 financial results. The company will issue a pre-market earnings announcement on the same day. Investors can join the call via a toll-free dial-in number or through a webcast available on Ocugen's website for approximately 45 days post-call. Ocugen focuses on developing innovative gene therapies and vaccines aimed at addressing unmet medical needs.
Ocugen, Inc. (NASDAQ: OCGN) announced two significant presentations at the ARVO 2022 Annual Meeting related to its innovative treatments for age-related macular degeneration (AMD) and diabetic macular edema (DME). The company is showcasing its RORA modifier gene therapy, OCU410, aimed at treating dry AMD, and a biologic product candidate, OCU200, for wet AMD and DME. Both presentations highlight promising approaches to combat these vision-threatening conditions, which currently have limited treatment options and affect millions.
Ocugen announced that the independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of its Phase 1/2 clinical trial for OCU400, a modifier gene therapy candidate aimed at treating Retinitis Pigmentosa linked to NR2E3 and RHO mutations. The study recently dosed its first patient, and there were no serious adverse events reported. This therapy has the potential to address multiple retinal diseases with a single product, showcasing Ocugen's innovative approach in gene therapy.
Ocugen (NASDAQ: OCGN) announced that Dr. Shankar Musunuri, Chairman and CEO, will present at NobleCon18, Noble Capital Markets’ Eighteenth Annual Investor Conference on April 21, 2022, at 10:30 AM ET. The event will take place at the Hard Rock Hotel & Casino in Hollywood, Florida. A high-definition video webcast of the presentation will be available the next day on Ocugen’s website and Noble’s conference website. This event highlights Ocugen’s focus on advancing biotechnology and their innovative therapies.
Ocugen has expanded its agreement with Bharat Biotech to include the commercialization of COVAXIN™ in Mexico, granting it rights across North America. The vaccine is already authorized for emergency use in adults in Mexico and is under review for children aged 2-18. Dr. Shankar Musunuri, Ocugen's CEO, expressed optimism about the vaccine's role in combatting COVID-19 in Mexico. COVAXIN™ is noted for its robust immune response and logistical advantages. The agreement retains the same profit-sharing structure as in the U.S.
Ocugen announced that the FDA placed its Phase 2/3 immuno-bridging study for COVAXIN™ on clinical hold due to a voluntary pause in dosing participants. This decision follows the World Health Organization’s inspection of Bharat Biotech's manufacturing facility. The company aims to address the FDA's questions while evaluating these findings. Ocugen remains focused on advancing its innovative therapies and will collaborate with the FDA to resolve the clinical hold for OCU-002.
Ocugen, a biotechnology company, has commenced the Phase 1/2 clinical trial of OCU400 for treating retinitis pigmentosa (RP), marking its first clinical trial in humans for its modifier gene therapy platform. The first patient has been dosed in this observer-blind trial, which aims to evaluate safety and efficacy. RP, affecting approximately two million people globally, currently has no approved therapies. The trial focuses on genetic mutations in the NR2E3 and RHO genes, with potential future expansions to target more mutations.
Ocugen, Inc. (NASDAQ: OCGN) has appointed Dr. Marna C. Whittington to its Board of Directors, effective March 21, 2022. Dr. Whittington, a seasoned financial leader, previously served as CEO of Allianz Global Investors Capital and has held positions at Morgan Stanley and the University of Pennsylvania. Her expertise is expected to bolster Ocugen's growth strategy concerning its gene therapies and vaccine candidates. The announcement follows the departure of Manish Potti, who did not seek reappointment, expressing confidence in the company's future in addressing unmet medical needs.
Ocugen, Inc. (NASDAQ: OCGN) announced the appointment of Jessica Crespo as Chief Accounting Officer and Senior Vice President, Finance, effective March 18, 2022. With over 20 years of experience, Crespo previously served as Vice President, Corporate Controller, and Treasurer at Ocugen. Her responsibilities include financial strategy development and oversight of accounting and reporting functions. Chairman Dr. Shankar Musunuri emphasized her valuable contributions, crucial to sustaining the company’s growth as it advances therapies toward regulatory approval.