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0.028225806451613 0.0322580645161291 0.0564516129032259 0.0564516129032259 0.0604838709677419 0.0604838709677421 0.0120967741935485 0.0120967741935485
Stock impact report

Larimar Therapeutics Provides Nomlabofusp Development Update and Reports Fourth Quarter and Full Year 2024 Financial Results

Larimar Therapeutics, Inc. (LRMR) 
Company Research Source: GlobeNewswire
FDA stated in written correspondence for a START pilot program meeting that it is open to considering skin FXN concentration as a reasonably likely surrogate endpoint in support of an accelerated approvalFDA recommended measuring skin FXN concentrations to support evidence of effectiveness for accelerated approval pathway and acknowledged submitted data appear sufficient to support relationship between increased skin FXN concentrations and relevant tissues such as heart, dorsal root ganglia and skeletal muscleLarimar is continuing discussions with FDA on the adequacy of the safety data set to support BLA submission BLA seeking accelerated approval targeted for submission by year-end 2025FDA and EMA feedback obtained on global Phase 3 study protocol; study planned to initiate in mid-2025Topline 50 mg dose data from the OLE study and available data from the adolescent cohort of the PK run-in study planned for program update in September 2025Strong balance sheet of $183.5 million cash, c Show less Read more
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