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. (OCGN) is a clinical-stage biopharmaceutical company pioneering gene therapies for retinal diseases and innovative vaccine platforms. This dedicated news hub provides investors and researchers with timely updates on Ocugen’s scientific advancements, regulatory milestones, and strategic initiatives.
Access verified press releases and curated financial news covering clinical trial developments, partnership announcements, and corporate updates. Our repository includes updates on modifier gene therapy programs for conditions like retinitis pigmentosa, inhaled vaccine research, and ocular disorder treatments undergoing regulatory review.
Key content categories include progress reports on Phase I-III trials, FDA designations, intellectual property updates, and financial performance summaries. Bookmark this page for streamlined tracking of OCGN’s advancements in gene editing technologies and mucosal vaccine development.
Ocugen (NASDAQ: OCGN) announced positive 2-year data from its Phase 1/2 clinical trial of OCU400, a novel modifier gene therapy for retinitis pigmentosa (RP). The trial showed that 100% of treated subjects (9/9) demonstrated improvement or preservation in visual function compared to untreated eyes at both one and two years.
Key findings include statistically significant improvement in visual function across multiple mutations (p=0.01), with meaningful improvement of 2-line gain in low-luminance visual acuity. The therapy showed a favorable long-term safety profile with no serious adverse events. OCU400 aims to treat approximately 2 million patients globally (~300,000 in U.S./EU) with a one-time therapy.
The company's Phase 3 OCU400 liMeliGhT clinical trial is ongoing, with BLA submission targeted for first half of 2026.
Ocugen (NASDAQ: OCGN) announced positive safety data from the Data and Safety Monitoring Board (DSMB) review of their OCU410 ArMaDa Phase 1/2 clinical trial for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The DSMB assessed data from 15 Phase 2 subjects, finding OCU410 to be safe and well-tolerated with no serious adverse events reported.
The Phase 2 study involves 45 subjects randomized across two treatment groups and one control group. Unlike current GA treatments requiring 6-12 annual injections, OCU410 aims to be a one-time treatment. The trial showed promising Phase 1 results, including reduced lesion growth, preserved retinal tissue, and improved low luminance visual acuity. The study is being conducted at 13 retinal surgery centers across the U.S., with dosing expected to complete in early 2025.
Ocugen (NASDAQ: OCGN) announced that CEO Dr. Shankar Musunuri will present at the Oppenheimer Movers in Rare Disease Summit on December 12, 2024, at the Westin Grand Central, New York. The presentation will focus on the company's progress in developing modifier gene therapies for inherited retinal diseases.
Dr. Musunuri will discuss two key programs: the Phase 3 OCU400 liMeliGhT clinical trial for retinitis pigmentosa (RP) and the Phase 1/2 OCU410ST GARDian clinical trial for Stargardt disease. The presentation is scheduled for 2:45-3:30 p.m. ET in the Grand Central Ballroom C&D. Company executives will also conduct one-on-one meetings with investors to discuss business and clinical development strategies.
Ocugen (NASDAQ: OCGN) announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, will present at NobleCon20 – Noble Capital Markets' 20th Annual Emerging Growth Equity Conference. The presentation is scheduled for December 3, 2024, at 1:30 p.m. ET at Florida Atlantic University in Boca Raton, FL.
The event will feature a presentation and moderated Q&A session, where Dr. Musunuri will provide updates on Ocugen's clinical programs. The company's executive team will also conduct one-on-one meetings with investors to discuss their business and clinical development strategy for their modifier gene therapy platform.
A video webcast will be available the following day on Ocugen's website, Noble Capital Markets' Conference website, and Channelchek, remaining accessible for 90 days.
Ocugen announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST to treat ABCA4-associated retinopathies including Stargardt disease. The designation offers benefits including protocol assistance, reduced fees, research grants, and 10 years of market exclusivity. Phase 1 dosing of the Phase 1/2 OCU410ST GARDian trial is complete, with the DSMB recommending progression to Phase 2. Preliminary data showed an 84% reduction in atrophic lesion growth in treated eyes versus untreated eyes. The treatment targets approximately 100,000 patients in the U.S. and Europe combined. OCU410ST previously received FDA orphan drug designation in April 2023.
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.
