Histogenics Corporation and Ocugen, Inc. announce merger agreement

On April 8, 2019, Histogenics Corporation and Ocugen, Inc. announced that they have entered into a definitive merger agreement under which the stockholders of Ocugen will become the majority owners of Histogenics’ outstanding common stock upon the close of the merger. The proposed merger will result in a combined publicly-traded, clinical-stage biopharmaceutical company operating under the Ocugen name. Ocugen, Inc. is a privately held, clinical-stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases.

Histogenics Corporation and Ocugen, Inc. announce merger agreement

On April 8, 2019, Histogenics Corporation and Ocugen, Inc. announced that they have entered into a definitive merger agreement under which the stockholders of Ocugen will become the majority owners of Histogenics’ outstanding common stock upon the close of the merger. The proposed merger will result in a combined publicly-traded, clinical-stage biopharmaceutical company operating under the Ocugen name. Ocugen, Inc. is a privately held, clinical-stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases.

Who We Are

Histogenics historically focused on the development of restorative cell therapies, including its product candidate, NeoCart, which is an innovative cell therapy that utilizes various aspects of Histogenics’ restorative cell therapy platform to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. In the third quarter of 2018, Histogenics announced that its Phase 3 clinical trial of NeoCart did not meet the primary endpoint of a statistically significant improvement in pain and function in a dual threshold responder analysis one year after treatment as compared to microfracture. Based on the totality of the data, Histogenics initiated a dialogue with the FDA in the third quarter of 2018 to discuss the regulatory path forward for NeoCart. Histogenics’ primary objective in these discussions was to determine whether the FDA would accept a submission of a BLA for NeoCart without data from an additional clinical trial. Histogenics had a constructive dialogue with the FDA, which included requests for, and review of, additional statistical analyses, different subgroup analyses, and secondary endpoints. These additional analyses did not change the conclusion that the NeoCart Phase 3 trial failed to meet its primary and secondary endpoints.

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