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Journavx (suzetrigine)

Vertex Pharmaceuticals · $VRTX

Standard Review Fast Track Breakthrough Therapy sNDA

PDUFA Date

December 5, 2026

Time Remaining

256 days

Review Type

Standard (10 mo)

92%

Baseline PoA

Historical sNDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Moderate-to-severe chronic lower back pain (NaV1.8 blocker)

Key Notes

Supplemental NDA expanding Journavx to chronic pain following acute pain approval.

⚠️ 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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