Alzheimer’s disease (AD) drug development remains the highest-stakes arena in biopharma. While the "Alzheimer’s Graveyard" is littered with multi-billion dollar failures, a new era of amyloid and tau-targeting therapies has proven that the regulatory path is navigable but only for those with a disciplined risk architecture. Success in 2026 is driven by Translational Clarity: the ability to prove that biological changes translate into human functional benefit.