FDA Clears Annovis to Start Pivotal Phase 3 Alzheimer's Studies for Buntanetap

Annovis Bio, Inc.

FDA clearance to proceed with pivotal Phase 3 studies for buntanetap in early Alzheimer's disease.
Two trials: a 6-month symptomatic study and an 18-month disease-modifying study.
A well-executed 6-month trial may support NDA filing within one year of initiation.
No safety concerns raised; FDA confirmed liver enzymes, drug interactions, dose selection acceptable.
CEO Maria Maccecchini says trial initiation planned early 2025.

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