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.
Ocugen (NASDAQ: OCGN) announced positive preliminary data from Phase 1 of its OCU410 ArMaDa clinical trial for geographic atrophy (GA). The trial evaluated nine patients across three dose cohorts, with the low-dose group showing 21.4% slower lesion growth compared to untreated eyes. The treatment demonstrated preservation of retinal tissue and improved visual function through low luminance visual acuity (LLVA) tests. OCU410 aims to be a single-dose treatment, potentially offering advantages over current treatments that require multiple injections. The condition affects approximately three million people in the US and Europe combined, with treatment options currently available.
Ocugen reported its Q3 2024 financial results and business updates. The company secured $30 million in debt financing and $35 million in equity financing, extending cash runway into Q1 2026. Their lead gene therapy program OCU400 for retinitis pigmentosa continues Phase 3 enrollment, with expansion into Canada. OCU410 is advancing in Phase 2 trials for geographic atrophy, while OCU410ST received DSMB approval for Phase 2 progression. Total operating expenses were $14.4 million for Q3 2024, compared to $16.1 million in Q3 2023. Cash position stood at $39.0 million as of September 30, 2024.
Ocugen has secured a new $30 million credit facility from Avenue Venture Opportunities Fund. The 4-year facility, fully funded at closing, will support general corporate purposes, capital expenditures, and working capital needs. The funding will primarily support clinical development of three first-in-class modifier gene therapies, including the completion of the OCU400 Phase 3 liMeliGhT clinical trial and preparation for BLA and MAA submissions. With this financing and current cash reserves, Ocugen's cash runway extends into Q1 2026.
Ocugen (NASDAQ: OCGN) announced an upcoming Clinical Showcase on November 12, 2024, at Nasdaq MarketSite in New York City. The event will highlight progress in their gene therapy clinical trials, including updates on the Phase 3 liMeliGhT trial for retinitis pigmentosa, preliminary data from the Phase 1/2 OCU410 ArMaDa trial for geographic atrophy, and progress on the Phase 1/2 OCU410ST GARDian study for Stargardt disease. The showcase will feature company executives, study investigators, and patient participants. Additionally, information about OCU200, a biologic candidate for diabetic macular edema entering Phase 1 trials, will be presented.
Ocugen, Inc. (NASDAQ: OCGN) announced that the Data and Safety Monitoring Board (DSMB) has approved enrollment for the second phase of the Phase 1/2 clinical trial for OCU410ST, a novel modifier gene therapy candidate for Stargardt disease. The DSMB determined the high dose of OCU410ST to be the maximum tolerated dose, with no serious adverse events reported. The trial will proceed to Phase 2 using high and medium doses.
The first phase enrolled nine patients receiving low, medium, or high doses of OCU410ST via subretinal injection. Dr. Charles Wykoff, a lead study investigator, noted that OCU410ST appears to be safe and well-tolerated. Ocugen's Chief Medical Officer, Dr. Huma Qamar, expressed enthusiasm about OCU410ST's potential to be the first one-time novel modifier gene therapy for Stargardt disease, addressing an unmet medical need for an estimated 100,000 patients in the U.S. and Europe.
Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene and cell therapies, biologics, and vaccines, has announced a conference call and live webcast scheduled for November 8, 2024, at 8:30 a.m. ET. The event will cover the company's third quarter 2024 financial results and provide a business update.
Ocugen will release a pre-market earnings announcement on the same day. Participants can join the call using the following details:
- U.S. callers: (800) 715-9871
- International callers: (646) 307-1963
- Conference ID: 9923172
A webcast will be available on the events section of the Ocugen investor site. A replay of the call and archived webcast will be accessible for approximately 45 days after the event.
Ocugen, a biotechnology company focused on gene and cell therapies, biologics, and vaccines, announced its participation in the 2024 Maxim Healthcare Virtual Summit. Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen, will join a panel discussion on Ocular Drug Development on Tuesday, October 15, 2024, from 11 a.m. to noon EDT.
The panel will explore advancements in vision enhancement, disease modification, and vision restoration. Dr. Musunuri expressed excitement about introducing Ocugen's first-in-class modifier gene therapy platform to investors. The summit, presented by Maxim Group , will feature presentations and discussions with CEOs and key management from various healthcare companies, along with industry panels. The event is exclusive to M-Vest members and will take place from October 15 to October 17, 2024.
Ocugen, Inc. (NASDAQ: OCGN) announced that the FDA has lifted the clinical hold on the investigational new drug application for the Phase 1 clinical trial of OCU200, a recombinant fusion protein designed to treat diabetic macular edema (DME). OCU200 targets the integrin pathway and could potentially benefit all DME patients, including those unresponsive to current anti-VEGF therapies.
The trial is a multicenter, open-label, dose-ranging study with three cohorts in the dose-escalation portion and a fourth cohort combining OCU200 with anti-VEGF therapy. DME affects approximately 746,000 people in the United States. Ocugen plans to explore additional indications for OCU200, including diabetic retinopathy and wet age-related macular degeneration, which collectively impact nearly nine million Americans.
Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company, announced that its Chairman, CEO, and Co-founder, Dr. Shankar Musunuri, will present at the 2024 Cell & Gene Meeting on the Mesa on October 7, 2024, at 1:30 p.m. MST in Phoenix, AZ. The presentation will focus on Ocugen's first-in-class modifier gene therapy platform, including:
- OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa
- OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy
- OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease
OCU400 is on track for its 2026 BLA and MAA approval targets. The company's executive team will also conduct one-on-one meetings to discuss business and clinical development strategies. Virtual attendance options are available for the conference.
Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company specializing in gene and cell therapies and vaccines, has announced its participation in Chardan's 8th Annual Genetic Medicines Conference. The event will take place on September 30-October 1, 2024 in New York.
Dr. Arun Upadhyay, Chief Scientific Officer and Head of Research & Development at Ocugen, will engage in an in-person fireside chat on September 30 at 10:30 a.m. ET. The session, moderated by Daniil Gataulin, PhD, Senior Biotech Research Analyst, will focus on Ocugen's modifier gene therapy approach for retinal diseases and the progress of ongoing clinical trials for retinitis pigmentosa, geographic atrophy, and Stargardt disease.
The fireside chat will be accessible via a live video webcast on the Ocugen investor site. Additionally, Ocugen's executive team will conduct one-on-one meetings with investors to discuss the company's business and clinical development strategy.
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