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Why Is Larimar Therapeutics Stock Plunging Despite Positive CTI-1601 Data?

05/11/2021 15:35
  • Larimar Therapeutics Inc (NASDAQ: LRMR) shares are trading lower despite announcing positive topline data from its Phase 1 multiple ascending dose trial evaluating CTI-1601 as a treatment for Friedreich's Ataxia (FA).
  • The data showed that repeated subcutaneous injections of CTI-1601 led to dose-dependent increases in FXN levels from baseline versus the placebo controls.
  • The repeated subcutaneous injections of CTI-1601 were generally well tolerated at doses up to 100mg administered daily for 13 days.
  • According to the company's 10-Q filing for Q1, the results from the non-human primate studies for the CTI-1601 program implied some safety concerns.
  • The company has reported mortality in a 90-day non-human primate study which is believed to be due to bacterial meningitis infection and had no connection with the drug.
  • In addition, mortalities have been observed in the ongoing 180 day-non-human primate study at the highest dose levels.  
  • The company says that it has informed the FDA of these findings and continues to dose non-human primates in the study and continue to collect and evaluate data.  
  • It says that additional non-clinical information may be required before initiating further clinical studies, based on all the information it has from the non-clinical program to date.
  • Price Action: LRMR shares dropped 33.3% at $8.75 during the market trading session on the last check Tuesday.