Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
HYMPAVZI (marstacimab) was approved by the FDA on June 5, 2026 for hemophilia A or B.
Pfizer Inc., HYMPAVZI (marstacimab) · Hemophilia A or B.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (12/22/25) through T+5. Run-up high $28.55 on 4/3/26, low $24.88 on 12/31/25 (T-120 to T-1). FDA decision 6/8/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-06-08
OutcomeApproved
Drug / candidateHYMPAVZI (marstacimab)
CompanyPfizer Inc.
120-day run-up (T-120→T-1)+0.7%
FDA record of the action: the FDA approved on June 5, 2026, per BLA 761369 SUPPL-3 (FDA letter). The sponsor announced it on June 8, 2026. 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 HYMPAVZI (marstacimab) approved by the FDA?
Yes. The FDA approved the application for HYMPAVZI (marstacimab) on June 5, 2026, per the FDA's own record. The company announced it on June 8, 2026. The primary source is linked on this page.
Which company is behind HYMPAVZI (marstacimab)?
HYMPAVZI (marstacimab) is a Pfizer Inc. (PFE) program. The FDA decision came on June 5, 2026; the FDA's own record of the decision is linked on this page.
How did PFE stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), PFE moved +0.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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