Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis

July 9, 2021 Auto Bot regulatory 0

Shots:

  • The FDA has granted FTD to LYS-GM101 for the Treatment of GM1 Gangliosidosis. The company has recently initiated an adaptative-design clinical trial evaluating the efficacy & safety of LYS-GM101 in 16 patients with GM1 gangliosidosis across the US & EU
  • The P-II/III clinical trial for MPS IIIA is ongoing, following collaboration with Sarepta whereas Sarepta will hold exclusive commercial rights to LYS-SAF302 in the US & EU & Lysogene will maintain commercial exclusivity in the EU
  • The FDA has granted RPDD in 2016 & ODD in 2017 for LYS-GM101. Lysogene has also entered into an exclusive WW license agreement with SATT Conectus for LYS-GM101 to treat Fragile X syndrome

Click here to read full press release/ article | Ref: Businesswire | Image: Lysogene

The post Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis first appeared on PharmaShots.