Ocugen reports Bahamas regulatory progress and MENA license for OCU400 in Q3 update
The company also dosed its first patient in a Phase 3 trial of OCU410 for geographic atrophy and said cash on hand extends its runway into 2028.
Ocugen, Inc. (NASDAQ: OCGN) reported third quarter 2026 results and a business update on November 4, 2026. For OCU400, its gene therapy for retinitis pigmentosa, the company said it was granted provisional approval and priority designation from the Longevity and Regenerative Therapies (LARTA) Board of The Bahamas, has an agreement with local partner GARM to manage the process, is progressing site readiness, and expects final approval and potential patient enrollment as early as year-end.1
Ocugen also completed an exclusive OCU400 license agreement for the Middle East and North Africa with Roots Pharmaceutical, under which it is eligible for up to $4 million in combined upfront license fee and development milestone payments, up to $255 million in potential sales milestones, and a 22% royalty on net sales, while retaining responsibility for manufacturing commercial supply.1 This is Ocugen's second regional OCU400 license agreement, following one with Kwangdong Pharmaceutical in South Korea.1 The company said topline data from the 140-patient Phase 3 liMeliGhT trial of OCU400 are expected in the first quarter of 2027, to be followed by a planned Biologics License Application submission, and that Process Performance Qualification batches have been completed to support the BLA and commercial launch supply.1
For OCU410ST in Stargardt disease, Ocugen said topline data from the Phase 2/3 pivotal confirmatory trial, enrolling 63 subjects, are anticipated in the second quarter of 2027, with a planned BLA submission to follow.1
For OCU410 in geographic atrophy, the company announced the first patient dosed in ArMaDa3, a 240-subject global Phase 3 trial randomizing patients 2:1 to a single subretinal injection of OCU410 or untreated control across the U.S., Canada, and Europe, with a primary endpoint of GA lesion growth over 12 months.1 It also presented 12-month Phase 2 ArMaDa2 results, including two podium presentations at AAO 2026.
On finances, Ocugen said cash, cash equivalents, restricted cash, and short-term investments totaled $84.6 million as of September 30, 2026, which the company expects will extend its runway into 2028.1
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