Ocugen Stock Surges 75% Year to Date: What's in Store for 2026?

By Zacks Equity Research | December 29, 2025, 9:53 AM

Ocugen OCGN is making rapid progress in its gene therapy programs for retinal diseases, which have differentiated mechanisms of action. With all three key pipeline programs moving on schedule, Ocugen plans to file three regulatory applications in the next three years.

This has led its stock to rise 75.1% so far in 2025, outperforming the industry’s increase of 20.9%.

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Enrollment is nearing completion in a phase III liMeliGhT study on lead modifier gene therapy candidate, OCU400, to treat retinitis pigmentosa (RP), a rare genetic disorder that can lead to vision loss and blindness. Top-line data from the phase III study is expected in the fourth quarter of 2026. Ocugen expects to file a biologics license application (BLA) and marketing authorization application for OCU400 in 2026, with a rolling BLA submission expected to begin in the first half of 2026. The FDA has granted orphan drug designation to OCU400 for treating RP.

RP disease is associated with mutations in more than 100 genes. Per the company, there is only one approved gene therapy for RP, which targets one of the 100 gene mutations associated with RP. OCU400 has shown the potential to treat multiple gene mutations associated with RP with a one-time subretinal injection.

The phase II/III GARDian3 pivotal confirmatory study for OCU410ST for Stargardt disease is also ongoing. There are no FDA-approved treatments available for Stargardt disease. Interim data from the study is expected in mid-2026, with a BLA filing planned for the first half of 2027.

Ocugen’s other important candidate, OCU410, is being developed in phase II as a one-time gene therapy for treating geographic atrophy (GA), an advanced stage of dry age-related macular degeneration. Data from the phase II study is expected in the first quarter of 2026, with phase III expected to begin in mid-2026.

Currently, patients with GA in the United States have only one option available, an anti-complement therapy, which requires multiple injections and only addresses one aspect of the disease. Ocugen believes that OCU410 addresses multiple aspects of the disease beyond the complement pathway and has the potential to change the treatment paradigm for GA.

It looks like 2026 will be a pivotal year for Ocugen with several key data readouts and regulatory updates planned, as discussed above.

Zacks Rank and Stocks to Consider

Ocugen has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL. ANIP, CRMD and CSTL currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 adjusted EPS have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 52.1% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while EPS estimates for 2026 have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 54.7% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 64 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 47.8% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report
 
CorMedix Inc (CRMD): Free Stock Analysis Report
 
Castle Biosciences, Inc. (CSTL): Free Stock Analysis Report
 
Ocugen, Inc. (OCGN): Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

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