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Investing.com - Guggenheim maintained its Buy rating and $26.00 price target on Larimar Therapeutics (NASDAQ:LRMR) following management meetings in New York.
The firm highlighted that FDA safety requirements for Larimar’s nomlabofusp are "much more favorable than standard ICH guidelines," suggesting regulatory comfort with the drug’s safety profile. Larimar is preparing a global Phase III study expected to be operational by the time of its Biologics License Application (BLA) submission, with potential U.S. commercial launch remaining on track for early 2027.
Larimar plans to present open-label extension (OLE) data in September 2025 from 30-40 participants who received at least one dose of nomlabofusp, including those on the 50 mg dose. Management expects to see disease stabilization trends rather than functional improvements given the severity of the enrolled population.
Additional lipid biomarker data is being presented at a cardiovascular conference this week, with Guggenheim noting the FDA specifically identified lipid data as "of particular interest." Data from the pharmacokinetic run-in adolescent study involving 14 participants aged 12-17 is also expected in September 2025.
Guggenheim believes Larimar’s "well-defined regulatory path to BLA and upcoming milestones position the company for meaningful momentum ahead," with the September OLE data and additional lipid data potentially further de-risking the program.
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