German pharmaceutical giant Bayer (ETR: BAYN) and its wholly owned subsidiary BlueRock Therapeutics LP announced that they have received Fast Track Designation from the US Food and Drug Administration (FDA) for OpCT-001. The investigational therapy, derived from induced pluripotent stem cells (iPSC), is intended for the treatment of primary photoreceptor diseases, a subgroup of hereditary retinal diseases that includes retinitis pigmentosa and rod cone malnutrition.
Partnership and Licensing Agreement
BlueRock Therapeutics, FUJIFILM Cellular Dynamics, and Opsis Therapeutics formed a partnership in 2021. Under this collaboration, BlueRock Therapeutics licensed OpCT-001 from the latter two US-based firms in January 2024. The Fast Track Designation from the FDA is expected to expedite the development and review process for OpCT-001, bringing hope to patients suffering from primary photoreceptor diseases.-Fineline Info & Tech
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