FDA selects Larimar's nomlabofusp for START pilot program to accelerate FA development

Larimar Therapeutics, Inc.

FDA selects nomlabofusp for START pilot program based on potential clinical benefit and program readiness.
Nomlabofusp is one of three CDER programs selected; BLA submission target remains 2H 2025.
START program offers enhanced ad-hoc FDA communication to expedite pivotal studies and BLA preparation.
Interim data from ongoing open-label extension study expected in Q4 2024.
Nomlabofusp aims to increase frataxin levels, addressing root cause of Friedreich's ataxia.

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