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Ocugen Announces Early Completion of Dosing in Phase 2/3 Pivotal Confirmatory Trial of OCU410ST for Stargardt Disease GARDian3 trial enrollment and dosing completed (N=63) in less than nine months Topline results expected in 2Q27 with BLA to follow by mid-2027 OCU410ST represents a potential first-in-class, one-time modifier gene therapy for all ABCA4 -associated retinopathies MALVERN, Pa., April 01, 2026 (GLOBE

#OCGN Ocugen Announces Early Completion of Dosing in Phase 2/3 Pivotal Confirmatory Trial of OCU410ST for Stargardt Disease

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Ocugen Provides Business Update with Fourth Quarter and Full Year 2025 Financial Results Ocugen (NASDAQ: OCGN) reported Q4 and full‑year 2025 results and a business update focused on three modifier gene therapy programs targeting BLAs over the next three years.Key developments: completed enrollment (140 patients) in the Phase 3 OCU400 liMeliGhT trial with topline data expected Q1 2027 and a planned rolling BLA in Q3 2026; positive 12‑month OCU410 Phase 2 data (46% lesion growth reduction; p=0.015; N=23); exclusive Korean license for OCU400; $18.9M cash at year‑end and $22.5M financing in Jan 2026 extending runway into Q4 2026.

#OCGN Ocugen Provides Business Update with Fourth Quarter and Full Year 2025 Financial Results

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Ocugen Announces Phase 3 liMeliGhT Enrollment Completion for OCU400, a Novel Modifier Gene Therapy for Broad Retinitis Pigmentosa Ocugen (NASDAQ: OCGN) completed enrollment for the Phase 3 liMeliGhT trial of OCU400 in broad retinitis pigmentosa, randomizing 140 patients 2:1 into treated and untreated control arms. Topline Phase 3 data are expected in 1Q 2027, supporting a planned rolling BLA and potential approval in 2027.Three‑year Phase 1/2 data show durable safety and tolerability, ~2‑line LLVA gain and 88% (7/8) evaluable treated subjects with improvement or preservation versus untreated eyes.

#OCGN Ocugen Announces Phase 3 liMeliGhT Enrollment Completion for OCU400, a Novel Modifier Gene Therapy for Broad Retinitis Pigmentosa

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Ocugen, Inc. Announces Pricing of $22.5 Million Offering of Common Stock Ocugen, Inc. (Nasdaq: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the pricing of its underwritten offering of 15,000,000 shares of its common stock at an offering price of $1.50 per share of

#OCGN Ocugen, Inc. Announces Pricing of $22.5 Million Offering of Common Stock

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Ocugen Stock Is Surging Today: What's Driving The Action? - Ocugen (NASDAQ:OCGN) Ocugen Inc (NASDAQ:OCGN) shares are up on Friday as the company is gaining traction following positive market sentiment.

Ocugen Stock Is Surging Today: What's Driving The Action? Ocugen Inc (NASDAQ:OCGN) shares are up on Friday as the company is gaining traction following positive market sentiment. read more

#benzai #MOON #OCGN #why #it's #moving #Movers #MOON #OCGN #Movers #Benzinga

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Ocugen Announces Positive Preliminary Phase 2 Data from OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration Ocugen, Inc. (Ocugen or the

#OCGN Ocugen Announces Positive Preliminary Phase 2 Data from OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

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Ocugen Announces Publication of Phase 1 GARDian1 Trial Results for OCU410ST Modifier Gene Therapy Ocugen (NASDAQ: OCGN) published peer‑reviewed Phase 1 GARDian1 results for OCU410ST, a modifier gene therapy for Stargardt disease, reporting 12‑month safety, tolerability, and exploratory efficacy data.Key findings in small Phase 1 cohort: 54% reduction in atrophic lesion growth in treated eyes versus fellow eyes, lesion expansion ~50% slower, treated eyes gained an average of +6 letters BCVA versus −1.5 letters in untreated eyes, 100% of treated eyes stabilized or improved, and no drug‑related serious adverse events. Phase 2/3 GARDian3 enrollment is expected to complete in Q1 2026 with a potential BLA filing in H1 2027.

#OCGN Ocugen Announces Publication of Phase 1 GARDian1 Trial Results for OCU410ST Modifier Gene Therapy

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Ocugen Provides Business Update with Third Quarter 2025 Financial Results Conference Call and Webcast Today at 8:30 a.m. ET Phase 2/3 OCU410ST GARDian3 pivotal confirmatory trial is progressing toward 1H 2027 Biologics License Application (BLA) filing with 50% enrollment completed to date European Medicines Agency (EMA) provided acceptability of a single U.S.-based trial

#OCGN Ocugen Provides Business Update with Third Quarter 2025 Financial Results

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$180M+ Sales Milestone Deal: Ocugen Partners with Korean Pharma Giant for Breakthrough Eye Gene Therapy Ocugen licenses OCU400 gene therapy for retinitis pigmentosa to Kwangdong Pharma, including $7.5M upfront, $180M+ in milestones, and 25% royalties. Phase 3 BLA filing targeted for 2026.

#OCGN Ocugen, Inc. and Kwangdong Pharmaceutical Co., Ltd. Complete License Agreement of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

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Ocugen, Inc. Announces $20 Million Registered Direct Offering of Common Stock and Warrants 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.

#OCGN Ocugen, Inc. Announces $20 Million Registered Direct Offering of Common Stock and Warrants

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Ocugen Provides Business Update with Second Quarter 2025 Financial Results 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.

#OCGN Ocugen Provides Business Update with Second Quarter 2025 Financial Results

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Ocugen, Inc. Announces First Patient Dosed in Phase 2/3 GARDian3 Pivotal Confirmatory Trial for OCU410ST—Novel Modifier Gene Therapy Candidate for Stargardt Disease Ocugen (NASDAQ: OCGN) has announced the dosing of its first patient in the Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST, a modifier gene therapy candidate for Stargardt disease. The trial follows encouraging Phase 1 results that showed 48% slower lesion growth and a statistically significant 2-line gain in visual acuity at 12-month follow-up.The Phase 2/3 study will enroll 51 participants, with 34 receiving a one-time subretinal injection of OCU410ST and 17 serving as untreated controls. The therapy targets ABCA4-associated retinopathies, affecting approximately 100,000 patients in the U.S. and Europe. Ocugen plans to submit a Biologics License Application (BLA) in 2027, based on one-year follow-up data.

#OCGN Ocugen, Inc. Announces First Patient Dosed in Phase 2/3 GARDian3 Pivotal Confirmatory Trial for OCU410ST—Novel Modifier Gene Therapy Candidate for Stargardt Disease

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Carisma Therapeutics and OrthoCellix Enter into Definitive Merger Agreement to Create Company Focused on Regenerative Cell Therapies for Orthopedic Diseases Carisma Therapeutics and OrthoCellix have entered into a definitive merger agreement to create a Nasdaq-listed company focused on regenerative cell therapies for orthopedic diseases. The combined entity will prioritize the development of OrthoCellix's Phase 3-ready NeoCart®, an autologous cartilage implant technology for knee cartilage defects. Under the agreement, OrthoCellix will merge with Carisma's subsidiary, with OrthoCellix stockholders and financing participants owning approximately 90% of the combined company, while existing Carisma stockholders will retain 10%. The merger includes a concurrent $25.0 million financing to fund NeoCart's Phase 3 trial. The combined company will be renamed OrthoCellix, Inc. and trade under the ticker 'OCLX'. The transaction is expected to close in second half of 2025, subject to stockholder approvals and regulatory requirements.

#OCGN Carisma Therapeutics and OrthoCellix Enter into Definitive Merger Agreement to Create Company Focused on Regenerative Cell Therapies for Orthopedic Diseases

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Close-up of a human eye with a digital biometric overlay representing advanced ocular technology, referencing Ocugen, Inc.

Close-up of a human eye with a digital biometric overlay representing advanced ocular technology, referencing Ocugen, Inc.

#OCGN signs licensing deal to bring its gene therapy for retinitis pigmentosa to Korea. With $11M in upfront and milestone payments and 25% royalties, the agreement expands global reach for OCU400—offering new hope for patients facing inherited blindness.
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Ocugen, Inc. Announces Signing of Binding Term Sheet for the License of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea Ocugen (NASDAQ: OCGN) has signed a binding term sheet for licensing OCU400, its modifier gene therapy for retinitis pigmentosa (RP), to a leading Korean pharmaceutical company. The agreement includes upfront fees and near-term development milestone payments of up to $11 million, plus sales milestones of $1 million for every $15 million in net sales. Ocugen will receive a 25% royalty on net sales and will manufacture the commercial supply. The deal targets approximately 15,000 RP patients in Korea. OCU400 is currently in Phase 3 clinical development with a planned Biologics License Application filing by mid-2026. This regional licensing strategy aligns with Ocugen's business development approach to partner with established companies while preserving rights in larger markets.

#OCGN Ocugen, Inc. Announces Signing of Binding Term Sheet for the License of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

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Ocugen Announces Rare Pediatric Disease Designation Granted for OCU410ST—Modifier Gene Therapy for the Treatment of Stargardt Disease Ocugen (NASDAQ: OCGN) has received Rare Pediatric Disease Designation (RPDD) from the FDA for OCU410ST, its gene therapy treatment for ABCA4-associated retinopathies, including Stargardt disease. This designation applies to serious diseases affecting children under 18 and fewer than 200,000 people in the U.S. The treatment already holds Orphan Drug designations from both FDA and European Medicines Agency. Approximately 100,000 people in the U.S. and Europe combined are affected by Stargardt disease. If the Priority Review Voucher (PRV) program is reauthorized, Ocugen could receive a voucher worth approximately $100 million. The company plans to begin Phase 2/3 pivotal confirmatory trials soon, targeting a Biologics License Application (BLA) filing in 2027.

#OCGN Ocugen Announces Rare Pediatric Disease Designation Granted for OCU410ST—Modifier Gene Therapy for the Treatment of Stargardt Disease

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Ocugen Provides Business Update with First Quarter 2025 Financial Results Ocugen (NASDAQ: OCGN) reported Q1 2025 financial results and provided updates on its gene therapy pipeline. The company's OCU400 Phase 3 trial for retinitis pigmentosa is progressing well, with potential BLA/MAA filings by mid-2026. Earlier Phase 1/2 data showed significant improvement in visual function. The company plans to initiate OCU410ST Phase 2/3 trial for Stargardt disease by mid-2025. In Q1, Ocugen completed dosing in OCU410 Phase 2 trial for geographic atrophy, showing promising 12-month data. Financially, Ocugen reported cash and restricted cash of $38.1M as of March 31, 2025, with runway into Q1 2026. The company posted a net loss of $0.05 per share, with total operating expenses of $16.0M. All three modifier gene therapies received Advanced Therapy Medicinal Product classification from EMA, potentially accelerating regulatory review.

#OCGN Ocugen Provides Business Update with First Quarter 2025 Financial Results

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Ocugen Provides Business Update with Fourth Quarter and Full Year 2024 Financial Results Ocugen (NASDAQ: OCGN) reported its Q4 and full year 2024 financial results, highlighting significant progress in its gene therapy programs. The company reached FDA alignment for OCU410ST's Phase 2/3 pivotal trial for Stargardt disease, potentially accelerating development by 2-3 years. Positive clinical data was reported across multiple programs:- OCU400 showed statistically significant (p=0.005) improvement in visual function at 2-year follow-up- OCU410 completed Phase 2 dosing with favorable safety profile- OCU410ST demonstrated 52% slower lesion growth and significant visual improvement in Phase 1Financial highlights include:- Q4 2024 R&D expenses: $8.3M (vs $7.8M in Q4 2023)- Q4 2024 net loss: $0.05 per share (vs $0.04 in Q4 2023)- Cash position: $58.8M as of December 31, 2024- Secured $65M in equity/debt financing in H2 2024- Runway extended into Q1 2026

#OCGN Ocugen Provides Business Update with Fourth Quarter and Full Year 2024 Financial Results

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Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST for Stargardt Disease Ocugen (NASDAQ: OCGN) has received FDA alignment to proceed with a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST, their modifier gene therapy candidate for Stargardt disease. The GARDian trial demonstrated promising results, including:- 52% slower lesion growth in treated eyes vs untreated eyes at 6-month follow-up- Statistically significant 2-line improvement in visual function- Favorable safety profile with no serious adverse eventsThe upcoming Phase 2/3 trial will involve 51 subjects, with 34 receiving a single subretinal injection of OCU410ST and 17 serving as untreated controls. The company aims for potential BLA filing by 2027. OCU410ST received orphan drug designations from both FDA and EMA in 2023 and 2024. Stargardt disease affects 44,000 patients in the U.S. with no current treatment options.

#OCGN Ocugen, Inc. Announces FDA Alignment on Phase 2/3 Pivotal Confirmatory Clinical Trial for Modifier Gene Therapy Candidate OCU410ST for Stargardt Disease

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Ocugen Launches Phase 1 Trial for Novel Eye Disease Treatment OCU200 in Diabetic Patients Ocugen begins clinical trials for OCU200, targeting diabetic macular edema. The innovative therapy could help millions who don't respond to current treatments.

#OCGN Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200—a Novel Integrin-Targeting Biologic for Diabetic Macular Edema

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Ocugen's Gene Therapy Shows 100% Success Rate in 2-Year Vision Loss Treatment Trial Revolutionary OCU400 therapy demonstrates complete efficacy in preserving vision for retinitis pigmentosa patients, with significant improvements across multiple mutations in Phase 1/2 trial.

#OCGN Ocugen, Inc. Announces Positive 2-Year Data Across Multiple Mutations from Phase 1/2 Clinical Trial of OCU400 —A Novel Modifier Gene Therapy for Retinitis Pigmentosa

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Ce soir mon club reçoit les Glasgow Rangers en coupe d'Europe. Je suis excité comme un alcoolique bavarois voyageur dans le temps qui assisterait à l'invention de la bière.
#ocgn #OGCNGR

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BREAKING NEWS: ( NASDAQ: #OCGN ) Ocugen CEO to Present at NobleCon20 - Noble Capital Markets' 20th Annual Emerging Growth Equity Conference

#StockMarket #News

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#OCGN Ocugen CEO to Present at NobleCon20 – Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference

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