Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
AVLAYAH (Tividenofusp alfa) was approved by the FDA on March 24, 2026 to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II), the 8th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Daily close, T-120 (10/8/25) through T+5. Run-up high $22.74 on 2/3/26, low $14.41 on 11/13/25 (T-120 to T-1). FDA decision 3/25/26. Historical price action, not a forecast.
Drug / candidateAVLAYAH (Tividenofusp alfa) - (COMPASS)
CompanyDenali Therapeutics Inc.
120-day run-up (T-120→T-1)+40.6%
FDA record of the action: the FDA approved on March 24, 2026, per BLA 761485 ORIG-1 (FDA letter). The sponsor announced it on March 25, 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 DNLI, 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 AVLAYAH (Tividenofusp alfa) approved by the FDA?
Yes. The FDA approved the application for AVLAYAH (Tividenofusp alfa) on March 24, 2026, per the FDA's own record. The company announced it on March 25, 2026. The primary source is linked on this page.
Which company is behind AVLAYAH (Tividenofusp alfa)?
AVLAYAH (Tividenofusp alfa) is a Denali Therapeutics Inc. (DNLI) program. The FDA decision came on March 24, 2026; the FDA's own record of the decision is linked on this page.
How did DNLI stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), DNLI moved +40.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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