FDA grants Orphan Drug Designation to BlueRock Therapeutics’ investigational cell therapy OpCT-001

Designation is for treating retinitis pigmentosa, one of the most common types of inherited retinal disorders characterized by the loss of photoreceptor cells  OpCT-001 is an iPSC-derived investigational cell therapy being clinically tested to treat retinitis pigmentosa  Berlin, Germany, and Cambridge, MA, USA January 22, 2026 – Bayer AG and its wholly owned, independently […]

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BlueRock Therapeutics investigative cell therapy bemdaneprocel for treating Parkinson’s disease receives Pioneering Regenerative Medical Product designation in Japan

Designation enables preferred procedural treatment and review consultation by Japan’s Ministry of Health, Labor and Welfare  Parkinson’s disease affects approximately 10 million people worldwide and 250,000 in Japan  Berlin, Germany and Cambridge, MA, USA, December 17, 2025 – Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy […]

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BlueRock Therapeutics advances investigational cell therapy bemdaneprocel for treating Parkinson’s disease to registrational Phase III clinical trial

Phase III exPDite-2 trial follows completion and discussion of Phase I trial data with US FDA under Regenerative Medicine Advanced Therapy (RMAT) designation  exPDite-2 is a randomized, sham surgery-controlled double-blind trial assessing efficacy and safety of bemdaneprocel in people living with moderate Parkinson’s disease  […]

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Cell Therapy and Vision Loss: A Primer on Primary Photoreceptor Diseases

Inherited retinal diseases (IRDs) represent a diverse and complex group of genetic disorders affecting the retina—the light-sensitive layer of tissue at the back of the eye. Within the IRD umbrella are primary photoreceptor diseases, which specifically cause photoreceptor degradation or dysfunction. These cells are […]

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