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JAGX FDA decision: Apr 29, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
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Canalevia-CA1 was approved by the FDA for chemotherapy-induced diarrhea (CID) in dogs; the approval was announced on April 29, 2026.

Jaguar Health Inc., Canalevia-CA1 · Chemotherapy-induced diarrhea (CID) in dogs.

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

PDUFA 4/29/26$63.175$8.43511/12/25
Daily close, T-120 (11/12/25) through T+5. Run-up high $63.175 on 11/25/25, low $8.435 on 4/28/26 (T-120 to T-1). FDA decision 4/29/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-29
OutcomeApproved
Drug / candidateCanalevia-CA1
CompanyJaguar Health Inc.
120-day run-up (T-120→T-1)-85.7%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was Canalevia-CA1 approved by the FDA?

Yes. The approval of the application for Canalevia-CA1 was announced on April 29, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.

Which company is behind Canalevia-CA1?

Canalevia-CA1 is a Jaguar Health Inc. (JAGX) program. The company announced the FDA decision on April 29, 2026; the primary source is linked on this page.

How did JAGX stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), JAGX moved -85.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.