Cortexyme Shares Slide Premarket as FDA Puts Hold on Atuzaginstat
January 26 2022 - 9:07AM
Dow Jones News
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)
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