Cortexyme Stock Plunges On FDA Hold On Atuzaginstat's IND
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- CRTX
The FDA has placed a clinical hold on Cortexyme Inc's (NASDAQ: CRTX) atuzaginstat (COR388) Investigational New Drug application (IND 134303).
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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