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Larimar Therapeutics Reports Second Quarter 2024 Operating and Financial Results
Open label extension (OLE) study is progressing with all 7 sites activated; interim data planned for Q4 2024Selected by Food and Drug Administration (FDA) to
About this update from Larimar Therapeutics, Inc.
[{"type":"text","content":"Open label extension (OLE) study is progressing with all 7 sites activated; interim data planned for Q4 2024Selected by Food and Drug Administration (FDA) to participate in Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program for nomlabofusp Joined TRACK-FA Neuroimaging Consortium as an industry partner; TRACK-FA collects natural history data to establish disease-specific neuroimaging biomarkers for potential use in clinical trialsPlanning initiation of pharmacokinetic (PK) run-in study in adolescents by year-end 2024; plan to transition adolescents into ongoing OLE study upon completion of PK studyPlanning initiation of global confirmatory study by mid-2025 with potential sites in the U.S., Europe, U.K., Canada, and AustraliaBiologics License Application (BLA) filing targeted for 2H 2025 to support accelerated approvalStrong balance sheet of $226.1 million cash, cash equivalents and marketable securities as of June 30, 2024, with projected cash runway into 2026 BALA CYNWYD, Pa., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its second quarter 2024 operating and financial results. “We made significant achievements in our nomlabofusp program this quarter that strongly position us for successful execution across important catalysts over the next 12 months. We were honored to be selected by the FDA to participate in the START pilot program which may be invaluable in helping us achieve our timeline for BLA submission targeted for the second half of 2025 to support accelerated approval. We are actively pursuing clinical sites in the U.S., Europe, U.K. Canada, and Australia in anticipation of initiating a global confirmatory study in mid-2025. We are excited to have recently joined the TRACK-FA Neuroimaging Consortium as an industry partner to support research to define disease-specific neuroimaging biomarkers for potential use in clinical trials.” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “Our OLE study continues to progress with all seven sites now activated and interim data planned for the fourth quarter of this year. We plan to initiate a PK run-in study in adolescents with Friedreich’s ataxia (FA) by year-end...