pdufa.bio
HomeDecisions › HALO 2026-03-05

HALO FDA decision — Mar 5, 2026

✓ APPROVED

Halozyme Therapeutics Inc. — TECVAYLI (teclistamab-cqyv) and DARZALEX FAS · Relapsed/refractory multiple myeloma (RRMM).

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

PDUFA 3/5/26$81.23$61.879/18/25
Daily close, T-120 (9/18/25) through T+5. Run-up high $81.23 on 2/9/26, low $61.87 on 12/15/25 (T-120 to T-1). FDA decision 3/5/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-05
OutcomeApproved
Drug / candidateTECVAYLI (teclistamab-cqyv) and DARZALEX FAS
CompanyHalozyme Therapeutics Inc.
120-day run-up (T-120→T-1)-9.7%