Cortexyme Stock Plunges On FDA Hold On Atuzaginstat’s IND


The FDA has placed a clinical hold on Cortexyme Inc’s CRTX atuzaginstat (COR388) Investigational New Drug application (IND 134303). 

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  • The Company plans to provide additional updates pending continued engagement with FDA.
  • Cortexyme is immediately implementing a cost reduction program to rationalize operations, providing an expected cash runway through 2024. 
  • Related content: Benzinga’s Full FDA Calendar.
  • The Company intends to prioritize the development of its next-generation gingipain inhibitor, COR588, in Alzheimer’s disease. 
  • COR588 is currently completing a Phase 1 SAD/MAD study, and results are expected in Q2 of 2022. 
  • In addition, Cortexyme plans to explore strategic alternatives for its coronavirus program and non-Alzheimer’s indications for COR388. 
  • In November last year, the Company presented data from Phase 2/3 GAIN Trial of atuzaginstat in Alzheimer’s Disease.
  • The 643-participant 48-week trial failed to meet statistical significance on its co-primary cognitive and functional endpoints in the overall cohort.
  • Price Action: CRTX shares are down 34.0% at $5.98 during the premarket session on the last check Wednesday.

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