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%
FDA record of the action: the FDA approved on March 5, 2026, per BLA 761291 SUPPL-18 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was TECVAYLI (teclistamab-cqyv) approved by the FDA?
Yes. The FDA approved the application for TECVAYLI (teclistamab-cqyv) on March 5, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind TECVAYLI (teclistamab-cqyv)?
TECVAYLI (teclistamab-cqyv) is a Halozyme Therapeutics Inc. (HALO) program. The FDA decision came on March 5, 2026; the FDA's own record of the decision is linked on this page.
How did HALO stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), HALO moved -9.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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