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zilebesiran

Alnylam Pharmaceuticals · $ALNY

Priority Review Fast Track Breakthrough Therapy NDA

PDUFA Date

September 15, 2026

Time Remaining

175 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical NDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Hypertension (RNA interference — twice-yearly injection)

Key Notes

RNAi therapy reducing blood pressure with twice-yearly dosing. Potential paradigm shift in HTN treatment.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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