Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
Awiqli (insulin icodec-abae) was approved by the FDA on March 26, 2026 to improve glycemic control in adults with type 2 diabetes mellitus, the 10th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Novo Nordisk A/S, Awiqli (insulin icodec-abae) · Type 2 diabetes.
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (10/9/25) through T+5. Run-up high $63.98 on 1/27/26, low $36.33 on 3/25/26 (T-120 to T-1). FDA decision 3/26/26. Historical price action, not a forecast.
Drug / candidateAwiqli (insulin icodec-abae) injection 700 u
CompanyNovo Nordisk A/S
120-day run-up (T-120→T-1)-38.2%
FDA record of the action: the FDA approved on March 26, 2026, per BLA 761326 ORIG-2 (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 Awiqli (insulin icodec-abae) approved by the FDA?
Yes. The FDA approved the application for Awiqli (insulin icodec-abae) on March 26, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind Awiqli (insulin icodec-abae)?
Awiqli (insulin icodec-abae) is a Novo Nordisk A/S (NVO) program. The FDA decision came on March 26, 2026; the FDA's own record of the decision is linked on this page.
How did NVO stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), NVO moved -38.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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