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

 ­ Ref: GlobeNewswire | Image: Cyprium