18 July 2019 - LifeMax Laboratories today announced that the FDA granted rare paediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.
If a new drug application for LM-030 is approved, LifeMax may be eligible to receive a rare paediatric disease priority review voucher, which can be redeemed to obtain priority review for any subsequent NDA or biological license application and can be sold or transferred.