Friday, November 07, 2025
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Ocugen Reports 3Q25 With Milestones For FY2026. Ocugen reported a 3Q25 loss of $20.1 million or $(0.07) per share and gave updates on its clinical programs. Importantly, all three clinical trials are meeting or beating our expectations for progress toward the BLA filings. We continue to expect “3 filings in 3 years”, with the first approval in mid-2027.
OCU400 Expected To Start Rolling BLA Filing In 1H26. OCU400 received RMAT designation from the FDA, allowing portions of the BLA to be submitted as they are completed rather than waiting to submit the entire BLA at once. The non-clinical portions are planned for submission in early 2026, with clinical trial data submitted in 4Q26. This should start the FDA review earlier and allow for approval in mid-2027.
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