Thursday, March 05, 2026
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.
FY2026 Reported With Important Milestones Ahead. Ocugen reported a loss for 4Q25 of $17.7 million or $(0.06) per share, with a FY2025 loss of $67.8 million or $(0.23) per share. Cash on December 31, 2025, was $18.6 million, not including $22.5 million from a common stock offering in January 2026. Importantly, the company confirmed several clinical trial milestones had been achieved or were on schedule for announcement later in 2026. This maintains the goal of submitting three BLAs for three products during the next three years.
Topline Data From OCU400 Expected In March 2027. The Phase 3 liMeliGhT trial testing OCU400 for retinitis pigmentosa (RP) has completed enrollment. The patients have a 1-year evaluation after treatment, with top-line data expected during March 2027. Ocugen plans to begin a rolling BLA submission with the Manufacturing and Preclinical Data sections later in 2026. The Phase 3 data and clinical sections are expected to be filed shortly after the final analysis. The full filing is expected to be completed in 1Q27. We anticipate 6-month review, with FDA approval received in Fall 2027.
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