Unverified record. The outcome below was inferred from the share-price reaction around this date. Nobody has confirmed it against an FDA, SEC or company document, and it may be wrong: we have published at least one inferred outcome that turned out to be impossible (see corrections). Treat it as a price observation, not as a regulatory fact. Verified decisions on this site always link a primary source.
pdufa.bio
HomeFDA Decisions › KALV 2025-07-07

KALV FDA Decision outcome unverified · 2025-07-07

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 7/7/25$14.76$7.41/20/25
Daily close, T-120 (1/20/25) through T+5. Run-up high $14.76 on 6/11/25, low $7.4 on 1/22/25 (T-120 to T-1). FDA decision 7/7/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-07-07
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move+25.7%
T-120 run-up (low→high)+38.0% ($10.32→$15.99)
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.

See the full 2026 PDUFA calendar →