Bayer (BAYRY) Wins FDA Orphan Drug Status for OpCT-001 Eye Treatment

Bayer AG (BAYRY) received U.S. Food and Drug Administration Orphan Drug Designation for OpCT-001 to treat retinitis pigmentosa, the company announced January 22, 2026. The designation for the rare genetic eye disease, affecting 1 in 3,000-4,000 people globally, provides seven-year market exclusivity and development tax credits upon approval. OpCT-001 is a preclinical cell therapy derived from induced pluripotent stem cells, developed by Bayer's BlueRock Therapeutics subsidiary. The treatment targets replacement of damaged retinal cells in the degenerative condition that can cause blindness. The orphan status waives prescription drug user fees and offers protocol assistance, potentially reducing Bayer's development costs. Bayer acquired full ownership of BlueRock in 2019 to expand its cell therapy pipeline.