Cyprium’s CUTX-101 Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Menkes Disease

 Cyprium’s CUTX-101 Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Menkes Disease

Cyprium’s CUTX-101 Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Menkes Disease

Shots:

  • The US FDA has granted BTD to CUTX-101 for the potential treatment of Menkes disease
  • The FDA has previously ODD, FTD and RPDD to CUTX-101 for the treatment of Menkes disease. Additionally, the EMA has previously granted ODD to CUTX-101
  • The rolling submission of NDA to the US FDA for CUTX-101 is expected to be initiated in Q1’21 and to be completed by the end of the Q2’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Cyprium