Ocugen secures licensing deal and outlines OCU400 timeline

Biotech company Ocugen has entered into a licensing agreement for the Middle East and North Africa regions, involving partners Roots Pharmaceutical and Al-Dhow International Holding. The deal includes an upfront payment and development-related milestones totaling up to $4 million, with potential revenue-based milestone payments reaching $255 million. Additionally, Ocugen will receive a 22 percent royalty on net sales while maintaining responsibility for manufacturing and delivery.

The company is focusing on its gene therapy candidate, OCU400. Ocugen plans to submit a Biologics License Application (BLA) in the United States by the second quarter of 2027, with topline data expected in the first quarter of that year.

Separately, the company has postponed an extraordinary general meeting regarding a proposal to increase the number of authorized common shares by 250 million. This capital increase is intended to secure financing for ongoing clinical studies.