Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
VEPPANU (vepdegestrant) was approved by the FDA on May 1, 2026 to treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, the 13th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Pfizer Inc., VEPPANU (vepdegestrant) · Breast cancer.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (11/14/25) through T+5. Run-up high $28.55 on 4/2/26, low $24.39 on 11/18/25 (T-120 to T-1). FDA decision 5/1/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-05-01
OutcomeApproved
Drug / candidateVEPPANU (vepdegestrant) - (VERITAC-2)
CompanyPfizer Inc.
120-day run-up (T-120→T-1)+7.4%
FDA record of the action: the FDA approved on May 1, 2026, per NDA 219835 ORIG-1 (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 VEPPANU (vepdegestrant) approved by the FDA?
Yes. The FDA approved the application for VEPPANU (vepdegestrant) on May 1, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind VEPPANU (vepdegestrant)?
VEPPANU (vepdegestrant) is a Pfizer Inc. (PFE) program. The FDA decision came on May 1, 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 +7.4%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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