Ocugen, Inc.

Ocugen, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational product OCU410 for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). This designation, supported by positive Phase 2 clinical data, is expected to expedite the regulatory path for OCU410, which is being developed as a one-time gene therapy. The company has aligned with the FDA on the Phase 3 trial design, with initiation expected in Q3 2026 and a BLA filing anticipated in 2028.

Ocugen, Inc. announced it will host a conference call and live webcast on Thursday, August 6, 2026, at 8:30 a.m. ET. The call will cover the company's second quarter 2026 financial results and provide a business update. A pre-market earnings announcement is also scheduled for the same day.

Ocugen, Inc. announced a binding term sheet with Roots Pharmaceutical and Al-Dhow International Holding to license its OCU400 modifier gene therapy for Retinitis Pigmentosa in the Middle East and North Africa (MENA) region. Under the agreement, Ocugen is set to receive up to $4 million in upfront and near-term development milestones, up to $255 million in sales milestones, and a 22% royalty on net sales. Ocugen will also manufacture and supply OCU400. The definitive agreement is anticipated within 90 days, while OCU400 continues its Phase 3 clinical development with a topline readout expected in Q1 2027.

Ocugen, Inc. announced a binding term sheet for a licensing agreement with Roots Pharmaceutical and Al-Dhow International Holding for exclusive rights to OCU400, its gene therapy for Retinitis Pigmentosa, in the Middle East and North Africa (MENA) region. Under the agreement, Ocugen is set to receive up to $4 million in upfront and near-term development milestone payments, along with up to $255 million in sales milestones and a 22% royalty on net sales. Ocugen will also manufacture and supply OCU400, expanding its reach into a region with high prevalence of RP.

Ocugen, Inc. announced it will present on its innovative modifier gene therapy platform at several investor and industry conferences in July 2026. Key presentations include a fireside chat at Piper Sandler Virtual Ophthalmology Day and a panel discussion at the OIS Retina Innovation Summit. Most notably, the company will present OCU410 Phase 2 ArMaDa 1-year results and Phase 1/2 OCU410 quantitative FAF/SD-OCT analysis and safety outcomes at the American Society of Retina Specialists (ASRS) meeting.

Ocugen, Inc. held its 2026 Annual Meeting of Stockholders, where shareholders elected Kirsten Castillo, MBA, and Satish Chandran, Ph.D., as Class III Directors. They also ratified PricewaterhouseCoopers LLP as the independent registered public accounting firm for 2026 and approved, on an advisory basis, the compensation of named executive officers, preferring an annual frequency for future advisory votes. Additionally, Mohamed Genead, M.D., M.Sc., was appointed Chief Medical Officer, effective June 11, 2026, after serving as Acting/Interim CMO.

Ocugen, Inc. announced a change in its accounting leadership. Ramesh Ramachandran resigned as the Chief Accounting Officer, effective May 29, 2026. Following his departure, Rita Johnson-Greene, who currently serves as the company's Chief Financial Officer, was appointed as the principal accounting officer on June 3, 2026.

Ocugen, Inc. announced a change in its Chief Medical Officer role, effective May 8, 2026. Huma Qamar, M.D., MPH, CMI, separated from the company as CMO. Concurrently, Mohamed Genead, M.D., M.Sc., was appointed as the Acting/Interim Chief Medical Officer.

Ocugen, Inc. announced the closing of its private offering of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034, which includes the full exercise of a $15.0 million over-allotment option. The company expects approximately $112.6 million in net proceeds, using $32.7 million to repay an outstanding loan. This financing is anticipated to extend Ocugen's cash runway into 2028, supporting the advancement of three late-stage programs and the goal of filing three BLAs by 2028.

Ocugen, Inc. announced the closing of a private offering of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034, including the full exercise of an option for additional notes. The offering is expected to result in approximately $112.6 million in net proceeds for the company. Ocugen used about $32.7 million of these proceeds to fully repay its outstanding loan with affiliates of Avenue Capital Group, with the remainder allocated for general corporate purposes. This financing extends the company's cash runway into 2028, supporting its goal to advance three late-stage programs and file three Biologics License Applications (BLAs) by 2028.