Usability/Clinical CRL, Human-factors deficiencies (pouch opening, film placement) plus a requested PK study on packaging changes; no CMC or efficacy issues cited.
Price into the decision (T-120)
Daily close, T-120 (8/18/25) through T+5. Run-up high $7.49 on 10/24/25, low $2.95 on 1/30/26 (T-120 to T-1). FDA decision 2/2/26. Historical price action, not a forecast.
Decision facts
FDA decision date2026-02-02
Outcome✗ CRL✓ source-verified
Decision-day move+39.0%
T-120 run-up (low→high)+27.0% ($2.95→$7.49)
CRL reasonUsability/Clinical, Human-factors deficiencies (pouch opening, film placement) plus a requested PK study on packaging changes; no CMC or efficacy issues cited.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=279)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.