Ocugen

Despite a downturn in the drug and biotech sector, innovation remains strong, with FDA approvals at a rapid pace. Five promising biotech stocks include MindMed, Beam Therapeutics, Arcellx, Ocugen, and Insmed, each with novel pipeline candidates. These companies, though currently reporting losses, could see significant revenue if their drugs are approved, making them high-risk, high-reward investments for the next 2-3 years.

Ocugen's Chairman, CEO, and Co-Founder, Dr. Shankar Musunuri, will present at the Oppenheimer Movers in Rare Disease Summit on Dec 12, 2024, discussing Ocugen's modifier gene therapies for retinitis pigmentosa and Stargardt disease. The presentation will cover ongoing Phase 3 and Phase 1/2 clinical trials, respectively.

EMA grants orphan medicinal product designation to OCU410ST for treating ABCA4-associated retinopathies, including Stargardt disease. Ocugen plans to pursue an accelerated marketing authorisation application, with Phase 1/2 GARDian trial showing 84% reduction in atrophic lesion growth.

Ocugen's CEO, Dr. Shankar Musunuri, to present at NobleCon20 on Dec 3, 2024, discussing clinical programs and business strategy. The presentation will be webcast and archived for 90 days.

EMA grants orphan medicinal product designation to OCU410ST for treating ABCA4-associated retinopathies, including Stargardt disease. The FDA previously granted orphan drug designation in April 2023. OCU410ST's Phase 1/2 GARDian trial for Stargardt disease completed dosing, with a 6-month data showing an 84% reduction in atrophic lesion growth. Ocugen plans to pursue an accelerated marketing authorization application.

Ocugen, Inc. received orphan medicinal product designation from the EMA for OCU410ST, a treatment for ABCA4-associated retinopathies including Stargardt disease. The designation supports Ocugen's efforts to address these rare eye conditions, offering benefits like protocol assistance and market exclusivity. The FDA previously granted orphan drug designation to OCU410ST in April 2023. Ocugen's ongoing Phase 1/2 trial has shown promising results, with an 84% reduction in atrophic lesion growth in treated eyes. OCU410ST leverages an AAV delivery platform for the RORA gene, targeting Nuclear Hormone Receptors to regulate photoreceptor health.

Ocugen announced EMA's orphan medicinal product designation for OCU410ST, treating ABCA4-associated retinopathies like Stargardt disease. The FDA previously granted orphan drug designation in 2023. OCU410ST's Phase 1/2 GARDian trial showed a 84% reduction in atrophic lesion growth, with favorable safety and tolerability.

Switch Market flag for country-specific data. Right-click on chart for more options. Use up/down arrows to navigate symbols.