Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
AMBELVIST (gadoquatrane) was approved by the FDA on June 12, 2026 to detect and visualize lesions with abnormal vascularity, in conjunction with MRI, the 21st novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Bayer AG ADR, AMBELVIST (gadoquatrane) · Contrast-enhanced magnetic resonance imaging (MRI).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (12/29/25) through T+5. Run-up high $14.4 on 2/19/26, low $9.88 on 6/2/26 (T-120 to T-1). FDA decision 6/15/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-06-15
OutcomeApproved
Drug / candidateAMBELVIST (gadoquatrane)
CompanyBayer AG ADR
120-day run-up (T-120→T-1)-0.1%
FDA record of the action: the FDA approved on June 12, 2026, per NDA 219627 ORIG-1 (FDA letter). The sponsor announced it on June 15, 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 AMBELVIST (gadoquatrane) approved by the FDA?
Yes. The FDA approved the application for AMBELVIST (gadoquatrane) on June 12, 2026, per the FDA's own record. The company announced it on June 15, 2026. The primary source is linked on this page.
Which company is behind AMBELVIST (gadoquatrane)?
AMBELVIST (gadoquatrane) is a Bayer AG ADR (BAYRY) program. The FDA decision came on June 12, 2026; the FDA's own record of the decision is linked on this page.
How did BAYRY stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), BAYRY moved -0.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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