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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 Receives Orphan Drug Designation from FDA for OCU410ST aimed at treating ABCA4-associated retinopathies, including Stargardt disease, Retinitis Pigmentosa 19, and Cone-Rod Dystrophy 3. This designation highlights the potential of OCU410ST to address a significant gap in treatment options for the approximately 44,000 patients in the U.S. affected by these conditions. The gene therapy utilizes an AAV delivery platform to administer the RORA gene, which plays a crucial role in retinal health. Ocugen plans to submit an IND application in Q2 2023 to start a Phase 1/2 clinical trial, furthering their commitment to innovative treatments in rare retinal diseases.
Ocugen, a biotechnology firm focused on innovative therapies, announced that its CEO, Dr. Shankar Musunuri, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, from 11 a.m. to 11:30 a.m. EDT. The event will be held at the Nasdaq Market Site in New York City.
Dr. Musunuri will discuss the company's advancements, including positive results from the ongoing OCU400 Phase 1/2 trial, and outline expected milestones. Investors can also schedule one-on-one meetings with Ocugen's leadership team during the conference.
A live video webcast of the discussion will be available on Ocugen's investor site.
MALVERN, Pa., April 20, 2023 (GLOBE NEWSWIRE) -- Ocugen (NASDAQ: OCGN) is set to present its innovative modifier gene therapy platform at the ARVO 2023 Annual Meeting from April 23-27, 2023. The therapies include OCU400, targeting retinitis pigmentosa and Leber congenital amaurosis, OCU410 for dry age-related macular degeneration (dry AMD), and OCU410ST for Stargardt disease, along with biomolecule OCU200 for diabetic macular edema (DME). Following positive Phase 1/2 trial results for OCU400, Ocugen aims to share its advancements in treating complex retinal diseases affecting millions globally. Key presentations by Ocugen team members are scheduled throughout the conference, providing crucial insights into their ongoing research and development efforts.
Ocugen, a biotechnology company, announced positive preliminary results from its Phase 1/2 clinical trial for OCU400, aimed at treating retinitis pigmentosa (RP) and Leber Congenital Amaurosis (LCA) associated with specific genetic mutations. The trial enrolled 18 RP subjects and demonstrated a favorable safety profile alongside visual improvements. Key data includes:
- 71.4% of treated eyes experienced at least 1 Lux luminance level improvement in mobility tests.
- 66.7% of low dose cohort eyes showed at least 2 Lux improvement at the 9-month follow-up.
- 100% of treated eyes had stable or improved mobility testing scores.
Ocugen believes these findings validate its modifier gene therapy platform and plans to pursue further long-term data collection and potential Phase 3 trials.
Ocugen Announces Investor Event for OCU400 Data
Ocugen, a biotechnology firm focused on gene and cell therapies, will host an Investor and Analyst Event on April 14, 2023, at 8 a.m. ET. The event aims to share preliminary safety and efficacy data from its ongoing Phase 1/2 trial of OCU400, targeting retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA). Members of the Ocugen leadership team, including CEO Shankar Musunuri and Chief Scientific Officer Arun Upadhyay, will present findings alongside noted experts in the field. Interested parties can join via a webcast or dial-in numbers. A replay will be accessible for 45 days post-event. Ocugen is committed to pioneering innovative therapies for severe retinal diseases.
Ocugen, a biotechnology firm focused on gene therapies, announced that Chief Scientific Officer Dr. Arun Upadhyay will present at the World Vaccine Congress in Washington D.C. on April 5, 2023. He will showcase Ocugen's innovative inhaled vaccine technology aimed at combating COVID-19 and influenza, addressing current vaccine limitations. The company is advancing multiple inhaled vaccine candidates, including OCU500 for COVID-19 and OCU510 for seasonal flu, targeting a significant market with over 170 million doses in the USA alone for the 2022-2023 flu season. This cutting-edge approach aims to enhance mucosal immunity and reduce transmission.
The FDA has approved Ocugen to enroll pediatric patients in its ongoing OCU400 Phase 1/2 trial, targeting those with inherited retinal diseases like RP and LCA. This approval follows the completion of adult patient enrollment. OCU400, a gene-agnostic modifier therapy, aims to treat multiple genetic mutations affecting retinal health, with RP affecting 110,000 and LCA 15,000 individuals in the U.S. The company plans to initiate the Phase 3 trial by the end of 2023, marking significant progress in their clinical endeavors.
Ocugen announced that Dr. Shankar Musunuri, CEO and Co-Founder, will participate in a fireside chat at the 35th Annual Roth Conference from March 12-14, 2023, at the Ritz Carlton in Laguna Niguel, California.
The chat is scheduled for March 13, 2023, at 9 a.m. PDT. Dr. Musunuri will discuss Ocugen's progress and upcoming milestones across its integrated pipeline. Additionally, the leadership team will conduct one-on-one meetings with registered investors during the event. A live video webcast will be available on Ocugen's investor site.
Ocugen, Inc. (NASDAQ: OCGN) announced the appointment of Quan A. Vu as Chief Financial Officer and Chief Business Officer, effective February 1, 2023. Vu's extensive experience in the healthcare sector, including roles at major firms like Morgan Stanley and Goldman Sachs, positions him to enhance Ocugen's financial strategy and business development initiatives. Dr. Shankar Musunuri, Ocugen's CEO, emphasized the integration of finance and business development under Vu's leadership, aiming to attract new partnerships and engage with investors effectively. This leadership change is anticipated to strengthen the company’s financial initiatives and support its clinical milestones.
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