By Colin Kellaher

 

Shares of Cortexyme Inc. tumbled sharply in premarket trading Wednesday after the company said the U.S. Food and Drug Administration has placed a full clinical hold on its investigational new drug application for atuzaginstat, its lead small molecule.

The South San Francisco, Calif., clinical-stage biopharmaceutical company said it has implemented a cost-cutting program aimed at allowing continued support for planned clinical milestones and providing an expected cash runway through 2024.

Cortexyme last year said a Phase 2/3 study of atuzaginstat for the treatment of Alzheimer's disease showed a relationship between reduction of P. gingivalis infection and the slowing of cognitive decline but didn't meet statistical significance on its co-primary cognitive and functional endpoints in the overall cohort.

The company said it plans to prioritize development of COR588, its next-generation gingipain inhibitor, in Alzheimer's disease, and that it will explore alternatives for its coronavirus program and non-Alzheimer's indications for atuzaginstat.

Cortexyme said it plans to provide updates on the atuzaginstat clinical hold pending continued engagement with the FDA.

Cortexyme shares, which closed Tuesday at $9.06, were down 29.6% to $6.47 in premarket trading.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

January 26, 2022 08:52 ET (13:52 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
Cortexyme (NASDAQ:CRTX)
Historical Stock Chart
From Apr 2022 to May 2022 Click Here for more Cortexyme Charts.
Cortexyme (NASDAQ:CRTX)
Historical Stock Chart
From May 2021 to May 2022 Click Here for more Cortexyme Charts.