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.
Arvinas 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 $13.83 on 2/4/26, low $9.82 on 4/29/26 (T-120 to T-1). FDA decision 5/1/26. Historical price action, not a forecast.
Positioning before the decision
On Apr 17, 2026, 14 days before the decision date, at-the-money options priced a move of ±15.4% through May 15, 2026 (the first listed expiry after the decision; ATM implied volatility 70%). The stock closed +6.2% at the first close across the decision and +2.9% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Drug / candidateVEPPANU (vepdegestrant) - (VERITAC-2)
CompanyArvinas Inc.
120-day run-up (T-120→T-1)-1.0%
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 an Arvinas Inc. (ARVN) program. The FDA decision came on May 1, 2026; the FDA's own record of the decision is linked on this page.
How did ARVN stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), ARVN moved -1.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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