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 […]
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 […]
Investigational cell therapy bemdaneprocel continues to demonstrate a favorable safety profile at 36 months in Phase I trial participants Secondary clinical efficacy endpoints related to motor outcomes remain stable compared to 24 months and continue to show positive trends from baseline Data were presented […]
BlueRock announced that the first patient has received randomized treatment in the pivotal Phase III clinical trial, exPDite-2, of bemdaneprocel, an investigational cell therapy for Parkinson’s disease.
Cambridge MA, USA, APRIL 16, 2025 – BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced the publication of the 18-month data from its Phase 1 exPDite clinical trial for bemdaneprocel in the journal Nature. “The […]
Berlin, Germany, and Cambridge, MA, USA February 27, 2025 – Bayer AG and BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for […]
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 […]
Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating individuals living with Parkinson’s disease At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high […]
OpCT-001 is the first iPSC-derived investigational cell therapy to be clinically tested for treating primary photoreceptor diseases Primary photoreceptor diseases are a subgroup of inherited retinal disorders that affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision […]
Regenerative Medicine Advanced Therapy (RMAT) designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated with no major safety issues through 18 months Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s […]
