Chordia Therapeutics Inc., a clinical-stage biotech company based in Fujisawa, Kanagawa Prefecture, Japan, has announced that rogocekib, its CLK inhibitor aimed at treating Refractory or Relapsed Acute Myeloid Lymphoma (AML), has been granted Orphan Drug Designation by the FDA in the United States. This designation is significant as it provides various developmental and financial benefits, including application fee exemptions, tax reductions, and exclusive market rights for seven years post-approval. These benefits are crucial for the potential commercialization of rogocekib.
Rogocekib is currently undergoing Phase 1/2 clinical trials in the U.S., highlighting Chordia Therapeutics' commitment to advancing novel cancer therapies. In addition to rogocekib, the company is also developing other preclinical assets, such as CTX-439, a CDK12 inhibitor, and GCN2 inhibitors, further demonstrating its dedication to innovative cancer treatment solutions.
