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 email@example.com
(END) Dow Jones Newswires