- 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
Dr. Russell Clayton, Chief Medical Officer of Larimar added, “Participating in the START program enables increased communication with the FDA to help expedite the progression of our nomlabofusp development program to the pre-BLA meeting stage. This is important to patients who are continuing to live with this devastating disease.”