StreetInsider.com News Articles

Ocugen doses first patient in Phase 3 gene therapy trial for dry AMD

Tue, 01 Sep 2026 07:02:16 -0400

Ocugen, Inc. (NASDAQ: OCGN) announced that the first patient has been dosed in its global Phase 3 registrational trial, ArMaDa3, evaluating OCU410, a gene therapy candidate for geographic atrophy (GA) secondary to dry age-related macular degeneration.

The trial is a multicenter, randomized, controlled study enrolling 237 subjects, randomized 2:1 to a single subretinal injection of OCU410 or an untreated control arm. Sites are located in the United States, Canada, Europe, and Latin America. A Biologics License Application filing is anticipated in 2028.

The U.S. Food and Drug Administration granted OCU410 Regenerative Medicine Advanced Therapy designation on July 29, 2026, based on Phase

Ocugen Announces First Patient Dosed in Phase 3 Registrational Trial of OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Tue, 01 Sep 2026 07:02:00 -0400

The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)
U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority review
Phase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028
OCU410 is designed as a one-time subretinal gene therapy that addresses multiple disease pathways, offering a differentiated approach from approved complement inhibitors in the U.S. which address individual disease pathways and require ongoing intravitreal

Ocugen Announces First Patient Dosed in Phase 3 Registrational Trial of OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Tue, 01 Sep 2026 07:02:00 -0400

The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)
U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority review
Phase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028
OCU410 is designed as a one-time subretinal gene therapy that addresses multiple disease pathways, offering a differentiated approach from approved complement inhibitors in the U.S. which address individual disease pathways and require ongoing intravitreal

Ocugen to Participate in Upcoming September Investor and Industry Conferences

Tue, 25 Aug 2026 07:02:00 -0400

MALVERN, Pa., Aug. 25, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Company will present on its innovative modifier gene therapy platform at upcoming investor and industry conferences in September 2026.

Citi 2026 Biopharma Back to School Conference
Location: JW Marriott Essex House, New York City, NY
Date: Wednesday, September 9, 2026
Time: 3:40–4:15 p.m. ET
Format: Fireside Chat
Presenter: Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen

H.C. Wainwright 28th Annual Global Investment Conference
Location: Lotte New York Palace, New

Ocugen to Participate in Upcoming September Investor and Industry Conferences

Tue, 25 Aug 2026 07:02:00 -0400

H.C. Wainwright 28th Annual Global Investment Conference
Location: Lotte New York Palace, New

Form DEFA14A Ocugen, Inc.

Fri, 14 Aug 2026 06:05:00 -0400

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Form DEFA14A Ocugen, Inc.

Fri, 14 Aug 2026 06:05:00 -0400

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Form SCHEDULE 13G/A Ocugen, Inc. Filed by: Janus Henderson Group Ltd.

Thu, 13 Aug 2026 12:42:00 -0400

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Form SCHEDULE 13G/A Ocugen, Inc. Filed by: Janus Henderson Group Ltd.

Thu, 13 Aug 2026 12:42:00 -0400

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Form SCHEDULE 13G Ocugen, Inc. Filed by: STATE STREET CORP

Fri, 07 Aug 2026 10:29:00 -0400

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Form SCHEDULE 13G Ocugen, Inc. Filed by: STATE STREET CORP

Fri, 07 Aug 2026 10:29:00 -0400

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Form 10-Q Ocugen, Inc. For: Jun 30

Thu, 06 Aug 2026 12:15:00 -0400

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Form 10-Q Ocugen, Inc. For: Jun 30

Thu, 06 Aug 2026 12:15:00 -0400

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Form 8-K Ocugen, Inc. For: Aug 06

Thu, 06 Aug 2026 08:31:00 -0400

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Form 8-K Ocugen, Inc. For: Aug 06

Thu, 06 Aug 2026 08:31:00 -0400

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Ocugen (OCGN) Misses Q2 EPS by 2c

Thu, 06 Aug 2026 07:53:31 -0400

Ocugen (NASDAQ: OCGN) reported Q2 EPS of ($0.07), $0.02 worse than the analyst estimate of ($0.05). Revenue for the quarter came in at $1.48 million versus the consensus estimate of $833.29 thousand.

For earnings history and earnings-related data on Ocugen (OCGN) click here.

Ocugen Provides Business Update with Second Quarter 2026 Financial Results

Thu, 06 Aug 2026 07:02:00 -0400

Conference Call and Webcast Today at 8:30 a.m. ET

Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter
Granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility for priority review and accelerated approval
Signed a binding term sheet with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, to negotiate an exclusive license for OCU400 in retinitis pigmentosa (RP) across the Middle East and North

Ocugen Provides Business Update with Second Quarter 2026 Financial Results

Thu, 06 Aug 2026 07:02:00 -0400

Conference Call and Webcast Today at 8:30 a.m. ET

Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter
Granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility for priority review and accelerated approval
Signed a binding term sheet with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, to negotiate an exclusive license for OCU400 in retinitis pigmentosa (RP) across the Middle East and North

Ocugen to Participate in Upcoming August Investor Conferences

Fri, 31 Jul 2026 07:02:00 -0400

MALVERN, Pa., July 31, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Company will present on its innovative modifier gene therapy platform at upcoming investor conferences in August 2026.

Oppenheimer 4^th Annual Biotech in the Berkshires Summit

Location: Miraval Resort, Lenox, MA
Date: Tuesday, August 4, 2026
Time: 12:30–1:10 p.m. ET
Session Title: Beyond the Readout: Building Durable Value in Rare Diseases & Gen Meds
Format: Panel discussion
Panelists: Shankar Musunuri, Pratik Shah, Ram

Ocugen to Participate in Upcoming August Investor Conferences

Fri, 31 Jul 2026 07:02:00 -0400

Oppenheimer 4^th Annual Biotech in the Berkshires Summit

Form DEFA14A Ocugen, Inc.

Thu, 30 Jul 2026 16:37:00 -0400

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Form DEFA14A Ocugen, Inc.

Thu, 30 Jul 2026 16:37:00 -0400

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Form DEF 14A Ocugen, Inc. For: Sep 21

Thu, 30 Jul 2026 16:31:00 -0400

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Form DEF 14A Ocugen, Inc. For: Sep 21

Thu, 30 Jul 2026 16:31:00 -0400

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Form SCHEDULE 13G Ocugen, Inc. Filed by: BlackRock, Inc.

Wed, 29 Jul 2026 15:21:00 -0400

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