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ENGN FDA Decision CRL · 2025-11-11

Mislabel — LEGEND clinical CR-rate data, BLA not filed

Price into the decision (T-120)

$8.53$3.62
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-11-11
Outcome✗ CRL⚠ label corrected
Decision-day move+46.8%
T-120 run-up (low→high)+154.0% ($3.31→$9.35)
CRL reasonMislabel — LEGEND clinical CR-rate data, BLA not filed
Primary sourceView filing ↗
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