Ocugen Inc Stock Price, News & Analysis

Ocugen (NASDAQ: OCGN), a biotechnology company specializing in gene therapies for blindness diseases, has scheduled a conference call and live webcast for Friday, May 9, 2025, at 8:30 a.m. ET. The event will cover the company's first quarter 2025 financial results and provide business updates.

The company will release its earnings announcement before the market opens on May 9. Investors can join via phone using U.S. dial-in (800) 715-9871 or international dial-in (646) 307-1963 with Conference ID 1773288. A webcast will be available on Ocugen's investor site, with a replay accessible for approximately 45 days after the event.

Ocugen announced upcoming presentations of its modifier gene therapy platform at two major ophthalmology events: The ARVO 2025 Annual Meeting in Salt Lake City (May 4-8) and Retina World Congress in Ft. Lauderdale (May 8-11). The company will showcase three key therapies:

• OCU400 for retinitis pigmentosa (Phase 3 LiMeliGhT trial)
• OCU410ST for Stargardt disease (Phase 2/3 pivotal trial)
• OCU410 for geographic atrophy (Phase 2 ArMaDa trial)

CEO Dr. Shankar Musunuri confirmed plans to file three Biologics License Applications/Marketing Authorization Applications within three years. The presentations include clinical trial updates, safety data, and efficacy results across multiple sessions. Dr. Huma Qamar, Chief Medical Officer, will lead the company showcase at Eyecelerator and participate in panel discussions at both events.

Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, announced its participation in the 2025 Cell & Gene Meeting on the Mediterranean in Rome, Italy from April 15-17, 2025.

Dr. Shankar Musunuri, Chairman, CEO, and Co-founder, will present on the panel 'Commercializing ATMPs: Moving from Innovation to Market Success' on April 15 at 10:45 a.m. CEST. The presentation will highlight Ocugen's modifier gene therapy platform and its potential to offer one-time treatments for major blindness diseases.

The company's gene therapy portfolio includes:

• OCU400 for retinitis pigmentosa
• OCU410ST for Stargardt disease
• OCU410 for geographic atrophy

Ocugen (NASDAQ: OCGN) announced positive safety data from the first cohort of its Phase 1 clinical trial for OCU200, a novel fusion protein designed to treat diabetic macular edema (DME). The Data and Safety Monitoring Board (DSMB) has approved proceeding with the second cohort after reviewing safety data from the initial group.

The trial is structured as a multicenter, open-label, dose-escalation study across three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). Patients receive two intravitreal injections six weeks apart with a 6-month follow-up period. No serious adverse events related to OCU200 have been reported.

OCU200, combining tumstatin and transferrin proteins, targets approximately 12 million people in the US and 130 million worldwide affected by DME, diabetic retinopathy (DR), and wet age-related macular degeneration. The company aims to complete the Phase 1 trial in H2 2025, particularly addressing the 30-40% of DME patients who don't respond to current anti-VEGF therapies.

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 1

Financial 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

Ocugen (NASDAQ: OCGN) has received positive ATMP classification from EMA's Committee for Advanced Therapies for two gene therapy candidates: OCU410 for Geographic Atrophy (GA) and OCU410ST for Stargardt disease.

Key highlights:

• OCU410 Phase 2 dosing is complete, with Phase 3 trials planned for next year, targeting MAA/BLA filings in 2028
• FDA endorsed OCU410ST Phase 2/3 pivotal trial, with potential submissions in 2027
• Preliminary 9-month OCU410 data showed 44% slower lesion growth and 2-line improvement in visual function
• OCU410ST 6-month data demonstrated 52% slower lesion growth and statistically significant visual improvement

Both therapies utilize AAV platform delivering RORA gene through a single subretinal injection. GA affects 2-3 million people in US/Europe, while Stargardt disease impacts 100,000 people, with no approved treatments in Europe.

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 events

The 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.

Ocugen (NASDAQ: OCGN), a biotechnology company specializing in gene and cell therapies, biologics, and vaccines, has scheduled a conference call and live webcast for Wednesday, March 5, 2025, at 8:30 a.m. ET. The event will cover the company's fourth quarter and full year 2024 financial results along with business updates.

The company will release its earnings announcement before the market opens on the same day. Investors can join via phone using the toll-free number (800) 715-9871 for U.S. callers or (646) 307-1963 for international participants, with Conference ID 5045393. A webcast will be available on Ocugen's investor site, with a replay accessible for approximately 45 days after the event.

Ocugen (NASDAQ: OCGN) has completed dosing in the Phase 2 portion of its Phase 1/2 ArMaDa clinical trial for OCU410, a novel gene therapy for geographic atrophy (GA), an advanced form of dry age-related macular degeneration (dAMD). The trial enrolled 51 subjects randomized into treatment and control arms.

The Phase 1/2 study (N=60) showed promising results with a 44% slower lesion growth in treated eyes versus untreated eyes at 9 months, and a clinically meaningful 2-line improvement in visual function. The therapy demonstrated a favorable safety profile with no serious adverse events.

OCU410 is designed as a one-time treatment, targeting multiple disease pathways, unlike current U.S. treatments that require monthly or bi-monthly injections. The trial is being conducted at 14 leading retinal surgery centers across the U.S., with Phase 3 studies planned for 2026 and potential BLA/MAA filings by 2028.