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

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

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  • 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

Click here to­ read the full press release 

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