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DNLI FDA decision — Mar 25, 2026

✓ APPROVED

Denali Therapeutics Inc. — AVLAYAH (Tividenofusp alfa) - (COMPASS) · Hunter syndrome MPS II.

Run-up into the decision (T-120 → T+5)

PDUFA 3/25/26$22.74$14.4110/8/25
Daily close, T-120 (10/8/25) through T+5. Run-up high $22.74 on 2/3/26, low $14.41 on 11/13/25 (T-120 to T-1). FDA decision 3/25/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-25
OutcomeApproved
Drug / candidateAVLAYAH (Tividenofusp alfa) - (COMPASS)
CompanyDenali Therapeutics Inc.
120-day run-up (T-120→T-1)+40.6%