Larimar in FDA Pilot Program for Nomlabofusp in Friedreich’s Ataxia

 

• START is a new milestone-driven program designed to accelerate development of novel therapies intended to address an unmet medical need for rare diseases
  
• Nomlabofusp was selected based on potential for clinical benefit in a rare neurodegenerative disease and demonstrated development program readiness
• START pilot program is intended to improve development efficiency through enhanced communication with the FDA
• Nomlabofusp is expected to be one of three CDER programs and one of six total programs selected by the FDA
• BLA submission continues to be targeted for 2H 2025

https://www.globenewswire.com/news-release/2024/05/30/2891132/0/en/Larimar-Therapeutics-Selected-by-FDA-to-Participate-in-START-Pilot-Program-for-Nomlabofusp-in-Friedreich-s-Ataxia.html