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) provided a business update and reported third quarter 2025 results. The company closed a $20M registered direct offering in August and would receive an additional $30M if warrants are fully exercised, and reported $32.9M cash on hand as of September 30, 2025.
Clinical progress includes 50% enrollment in the OCU410ST Phase 2/3 GARDian3 trial with a path toward a 1H 2027 BLA filing and EMA acceptability of a single U.S. trial for MAA submission. OCU400 Phase 3 enrollment is nearing completion with planned BLA/MAA filings in 2026. Ocugen executed an exclusive license for OCU400 in South Korea with upfront/milestone payments and sales milestones projected to reach $180M in the first 10 years and a 25% royalty.
Ocugen (NASDAQ: OCGN) will hold a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 5, 2025 to discuss third quarter 2025 financial results and provide a business update. The company will issue a pre-market earnings announcement the same day.
Dial-in numbers: U.S. (800) 715-9871, international (646) 307-1963; Conference ID: 3029428. The webcast is available in the events section of the Ocugen investor site. A replay and archived webcast will be available for approximately 45 days after the event.
Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, announced its participation in three major industry conferences in October 2025. The company will present at the Cell & Gene Meeting on the Mesa, Chardan's 9th Annual Genetic Medicines Conference, and the 2025 Maxim Growth Summit.
CEO Dr. Shankar Musunuri highlighted the company's goal of achieving three BLAs in the next three years. Executive Vice President Abhi Gupta will present a company update at Meeting on the Mesa, while Dr. Musunuri will participate in panel discussions at the Chardan and Maxim conferences. The events will also include one-on-one meetings with company leadership.
Ocugen (NASDAQ: OCGN) has executed a licensing agreement with Kwangdong Pharmaceutical for the exclusive Korean rights to OCU400, its modifier gene therapy for retinitis pigmentosa (RP). The deal includes upfront fees and near-term development milestone payments of up to $7.5 million, plus potential sales milestones of $180 million or more in the first 10 years of commercialization.
The agreement features 25% royalties on net sales and Ocugen will manufacture the commercial supply. The Korean market represents approximately 7,000 RP patients, about 7% of the U.S. market. Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target U.S. BLA filing in 2026, which Kwangdong will leverage for Korean regulatory approval.
Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, announced its participation in two major industry conferences. CEO Dr. Shankar Musunuri will present at the H.C. Wainwright Global Investment Conference (September 8-10, 2025) in New York and Biotech on Tap 2025 (September 24-26, 2025) in Munich.
At H.C. Wainwright, Dr. Musunuri will participate in a fireside chat on September 8 at 5 p.m. ET. During Biotech on Tap, he will join a panel discussion titled "The FDA Gauntlet: Strategies for a Successful Run at Approval" on September 25 at 3:30 p.m. CET. The company's executive team will also conduct one-on-one meetings to discuss their modifier gene therapy platform.
Ocugen (NASDAQ: OCGN) received positive scientific advice from the European Medicines Agency (EMA) regarding the approval pathway for OCU410ST, its gene therapy treatment for Stargardt disease. The EMA's Committee for Medicinal Products for Human Use (CHMP) has accepted a single U.S.-based trial for Marketing Authorization Application (MAA) submission.
The Phase 2/3 GARDian3 clinical trial will enroll 51 participants, with 34 receiving OCU410ST treatment and 17 serving as controls. The therapy has shown promising Phase 1 results, including 48% slower lesion growth and a statistically significant 2-line/9-letter gain in visual acuity (p=0.031). The company plans to complete enrollment by Q1 2026 and submit a Biologics License Application (BLA) in H1 2027.
The treatment targets approximately 100,000 Stargardt patients in the U.S. and Europe combined, who currently have no approved treatment options.Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has completed its previously announced $20 million registered direct offering. The offering includes 20 million shares of common stock and warrants at $1.00 per share.
The warrants allow purchase of up to 20 million additional shares at $1.50 per share, are immediately exercisable, and expire in two years. The company can call the warrants when the stock's VWAP exceeds $2.50 for at least 5 days in a 30-day period. If fully exercised, the warrants could provide additional proceeds of $30 million.
The offering proceeds are expected to extend Ocugen's cash runway into Q2 2026, or Q1 2027 if warrants are fully exercised.
Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has announced a $20 million registered direct offering of common stock and warrants. The company will sell 20 million shares at $1.00 per share to Janus Henderson Investors.
The offering includes warrants to purchase an additional 20 million shares at an exercise price of $1.50 per share, exercisable immediately and expiring in two years. If fully exercised, these warrants could provide up to $30 million in additional proceeds. The warrants are callable when the stock's VWAP exceeds $2.50 for at least 5 days in a 30-day period.
Ocugen (NASDAQ: OCGN) reported significant progress in Q2 2025 across its gene therapy pipeline. The company initiated dosing in the OCU410ST Phase 2/3 GARDian3 pivotal trial for Stargardt disease and continues actively dosing patients in the OCU400 Phase 3 liMeliGhT trial for retinitis pigmentosa, targeting 2026 BLA filing.
Key developments include a binding term sheet for Korean rights to OCU400 worth up to $11 million in upfront and milestone payments, plus 25% royalties. The company also announced a strategic reverse merger of OrthoCellix with Carisma Therapeutics to unlock value from its NeoCart technology. Financial results show $27.3 million in cash as of June 30, 2025, providing runway into Q1 2026, with a quarterly net loss of $0.05 per share.
The company's OCU410 demonstrated promising Phase 1 results, showing 23% slower geographic atrophy lesion growth and a 2-line gain in visual acuity.Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has announced significant additions to its leadership structure. The company has expanded its Retina Scientific Advisory Board (SAB) with three renowned retinal surgeons: Dr. Jeffrey S. Heier, Dr. Peter K Kaiser, and Dr. Arshad M. Khanani, joining existing members under the leadership of SAB chair Dr. Lejla Vajzovic.
Additionally, Ocugen has strengthened its executive team with two key appointments: Dr. Vijay Tammara as Chief Development Officer, bringing over 32 years of global regulatory leadership and experience with nine Marketing Authorization approvals, and Abhi Gupta as Executive Vice President of Commercial and Business Development, with extensive experience in gene therapy commercialization and a track record at companies like Pfizer and Johnson & Johnson.
These appointments align with Ocugen's strategic goal of pursuing three Biologics License Applications (BLAs) in the next three years.
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