• Ocugen is advancing OCU400 to address all gene mutations associated with retinitis pigmentosa (RP) with a single, one-time injection.
• The company is looking to make a rolling Biologics License Application for OCU400. 
• In a previous study, all subjects treated with OCU400 showed improvement or preservation in visual function compared to untreated eyes after two years.

Shares of Ocugen Inc. (OCGN) rose nearly 5% on Wednesday after the company said that it plans to start seeking the approval of the U.S. Food and Drug Administration (FDA) for its experimental therapy, OCU400, starting this year.

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Ocugen is advancing OCU400 to address all gene mutations associated with retinitis pigmentosa (RP) with a single, one-time injection.

“We plan to begin the rolling submission for the OCU400 Biologics License Application this year and potentially provide a treatment option for the 98% of RP patients for whom no therapy exists,” the company said in a post on LinkedIn.

About Retinitis pigmentosa

Retinitis pigmentosa (RP) is a group of rare, inherited genetic disorders causing slow, progressive retinal degeneration and vision loss, typically starting with night blindness and peripheral vision loss (tunnel vision) in childhood or young adulthood. Ocugen estimates the condition affects about 300,000 people in the U.S. and Europe combined.

In a previous study including 18 subjects, OCU400 demonstrated sustained favorable safety and tolerability. All the treated subjects showed improvement or preservation in visual function compared to untreated eyes after two years, the company said.

In November, the company said that it is looking to initiate an application to the FDA for approval of the therapy in the first half of 2026. Ocugen is looking to make a rolling Biologics License Application, an FDA-approved process that allows pharmaceutical companies to submit completed sections or modules of their application for review as they are finished, rather than waiting to submit the entire document at once.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around OCGN stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.

OCGN stock has more than tripled over the past 12 months. 

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