#41

FDA Lifts Clinical Hold on NUZ-001

  • U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®’s lead investigational therapy for ALS
  • Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025
  • IND supported by robust preclinical safety data and comprehensive manufacturing and quality information from the previously signed Elanco licensing agreement
  • Expedites NUZ-001 as a platform molecule with pipeline expansion potential for other neurodegenerative diseases
  • Positions Neurizon for accelerated regulatory pathways and future partnering opportunities
2 Likes
#42

FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial

Highlights:

  • FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol
  • This marks the official entry of NUZ-001 as Regimen I in the HEALEY ALS Platform Trial
  • Next steps include obtaining single IRB approval, site initiations and clinical start-up activities ahead of commencement of patient enrollment expected early in 2026
  • Milestone strengthens Neurizon’s pathway toward advancing a potential new treatment for ALS
2 Likes