Seelos Therapeutics Shares Gain On FDA Approval To Add SLS-005 Regimen In HEALEY ALS Trial

Seelos Therapeutics Shares Gain On FDA Approval To Add SLS-005 Regimen In HEALEY ALS Trial
  • The Sean M. Healey & AMG Center for ALS at Mass General received approval from the FDA and the Mass General Brigham Institutional Review Board to add SLS-005 (trehalose injection, 90.5 mg/ML for intravenous infusion) as an additional regimen in the HEALEY ALS Platform Trial.  
  • HEALEY ALS Trial Design Committee worked with Seelos Therapeutics Inc SEEL to include SLS-005’s pivotal Phase 2b/3 trial in amyotrophic lateral sclerosis (ALS) on the platform.
  • The drug received Orphan Drug Designation for ALS from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).
  • Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the blood-brain barrier, stabilizes proteins and, activates autophagy, which is the process that clears material from cells. 
  • The HEALEY ALS Platform Trial is designed to evaluate multiple investigational treatments simultaneously.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: SEEL stock is up 20.4% at $2.29 during the market session on the last check Tuesday.

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