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ADMA FDA decision: May 4, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

ADMA Biologics Inc, ASCENIV (RI-002) · Primary humoral immunodeficiency (PI) to pediatric.

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

PDUFA 5/4/26$20.38$8.2911/17/25
Daily close, T-120 (11/17/25) through T+5. Run-up high $20.38 on 12/18/25, low $8.29 on 3/27/26 (T-120 to T-1). FDA decision 5/4/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-04
OutcomeApproved
Drug / candidateASCENIV (RI-002)
CompanyADMA Biologics Inc
120-day run-up (T-120→T-1)-27.5%

Questions

Was ASCENIV (RI-002) approved by the FDA?

Yes. The FDA approved the application for ASCENIV (RI-002) on May 4, 2026. The primary source is linked on this page.

Which company is behind ASCENIV (RI-002)?

ASCENIV (RI-002) is a ADMA Biologics Inc (ADMA) program. The FDA decision came on May 4, 2026; the company's own announcement is linked on this page.

How did ADMA stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), ADMA moved -27.5%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.