Daily close, T-120 (10/13/25) through T+5. Run-up high $36.25 on 2/4/26, low $18.95 on 10/31/25 (T-120 to T-1). FDA decision 3/30/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-03-30
OutcomeApproved
Drug / candidatePONLIMSI (denosumab-adet) (biosimilar to Pro
CompanyTeva Pharmaceutical Industries Limited A
120-day run-up (T-120→T-1)+44.0%
FDA record of the action: the FDA approved on March 27, 2026, per BLA 761385 ORIG-1 (FDA letter). The sponsor announced it on March 30, 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 PONLIMSI (denosumab-adet) approved by the FDA?
Yes. The FDA approved the application for PONLIMSI (denosumab-adet) on March 27, 2026, per the FDA's own record. The company announced it on March 30, 2026. The primary source is linked on this page.
Which company is behind PONLIMSI (denosumab-adet)?
PONLIMSI (denosumab-adet) is a Teva Pharmaceutical Industries Limited (TEVA) program. The FDA decision came on March 27, 2026; the FDA's own record of the decision is linked on this page.
How did TEVA stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), TEVA moved +44.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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