Daily close, T-120 (10/13/25) through T+5. Run-up high $86.5 on 2/9/26, low $68.94 on 10/14/25 (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 / candidateSPINRAZA (Nusinersen) - (DEVOTE)
CompanyIonis Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+4.5%
FDA record of the action: the FDA approved on March 27, 2026, per NDA 209531 SUPPL-16 (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.
Specialist biotech funds holding IONS, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was SPINRAZA (Nusinersen) approved by the FDA?
Yes. The FDA approved the application for SPINRAZA (Nusinersen) 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 SPINRAZA (Nusinersen)?
SPINRAZA (Nusinersen) is an Ionis Pharmaceuticals Inc. (IONS) program. The FDA decision came on March 27, 2026; the FDA's own record of the decision is linked on this page.
How did IONS stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), IONS moved +4.5%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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