BiologicsLicenseApplication News & Analysis

Larimar Therapeutics (LRMR) Submits BLA Module for Nomlabofusp Therapy

On June 29, Larimar Therapeutics Inc. (NASDAQ: LRMR) filed the first module of its Biologics License Application (BLA) to the U.S. FDA for its Nomlabofusp therapy, aiming for accelerated approval. The company plans to submit additional modules in the second half of 2026. The therapy demonstrated positive outcomes in an open-label study for treating Friedreich's ataxia, with confirmed sufficient data for application approval based on a new surrogate endpoint. Analyst Christopher Chen from Baird reduced the target price from $7 to $5, indicating a potential upside of over 53% from current levels for investors.