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AMRX FDA decision: Jun 4, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED

Romidepsin injection solution was approved by the FDA for cutaneous T-cell lymphoma; the approval was announced on June 4, 2026.

Amneal Pharmaceuticals Inc., Romidepsin injection solution · Cutaneous T-cell lymphoma.

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

PDUFA 6/4/26$15.19$11.8112/18/25
Daily close, T-120 (12/18/25) through T+5. Run-up high $15.19 on 2/19/26, low $11.81 on 5/20/26 (T-120 to T-1). FDA decision 6/4/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-04
OutcomeApproved
Drug / candidateRomidepsin injection solution, 27.5 mg/5.5 m
CompanyAmneal Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+5.4%

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