CRTX - Cortexyme plunges 24% after FDA clinical hold on atuzaginstat study in Alzheimer's

Cortexyme (CRTX) tanks 24% premarket after receiving a letter from the FDA stating that a partial clinical hold has been placed on atuzaginstat (COR388) impacting the open-label extension ((OLE)) phase of the company’s Phase 2/3 study, the GAIN Trial (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease).Under the hold, no new participants will be enrolled in the OLE and current OLE participants will be discontinued.Participants in the fully enrolled (N=643) double-blind, placebo-controlled phase of the GAIN Trial will continue to receive study drug at their assigned dose, with top-line results in Q4. The partial clinical hold was initiated following the review of hepatic adverse events in the atuzaginstat trial by the FDA. These events have been reversible and without any known long-term adverse effects for the participants.Cortexyme will continue to collaborate with the FDA on the overall development program for atuzaginstat.

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Cortexyme plunges 24% after FDA clinical hold on atuzaginstat study in Alzheimer’s