Post by Sara Mallatt

Name: uniQure: The FDA did a 180 — again 🔄 Last week, the FDA reversed course on uniQure's AMT-130 gene
Uploaded: 2026-06-26T17:39:27.150Z
Channel: Sara Mallatt
Description: uniQure: The FDA did a 180 — again 🔄 Last week, the FDA reversed course on uniQure's AMT-130 gene therapy for Huntington's disease, clearing the way for a near-term approval filing. Same drug the FD

Director of Healthcare Research @AlphaSense | Equity Research | Primary Insights | Leader of Global Teams

uniQure: The FDA did a 180 — again 🔄 Last week, the FDA reversed course on uniQure's AMT-130 gene therapy for Huntington's disease, clearing the way for a near-term approval filing. Same drug the FDA embraced, rejected, and has now embraced again — a wild ride for a therapy showing a remarkable 75% slowing of disease progression. This matters beyond uniQure. New FDA leadership is signaling a more flexible posture toward rare disease gene therapies — the fastest-growing segment of the biologics market. Biotech stocks rallied on the news, further fueled by still-surging IPO and M&A activity. Liquidity is building. Let's keep an eye on it. 👇 Access my full research note here: https://lnkd.in/eB7gD-Ym

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