Logo

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

Share this

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

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

  Ref: Businesswire | Image: Lysogene

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions