The FDA Just Rewrote the Rules for Gene Therapy Approval & Most Investors Haven't Noticed Yet: The Plausible Mechanism Framework and NGS Safety Guidance That Could Reshape Rare Disease Investment

The Plausible Mechanism Framework and the NGS Safety Guidance, published as FDA draft guidances in February and April 2026, create the structural conditions for a fundamentally different approach to gene therapy approval. This episode explains what changed, why it matters, and what the downstream implications are for rare disease investment and gene the…