Eli Lilly And Co (LLY  ) presented full results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease.

The data were shared at the Alzheimer's Association International Conference and simultaneously published in the Journal of the American Medical Association.

Lilly previously announced that donanemab met the primary and all cognitive and functional secondary endpoints in the Phase 3 study.

Submission to the FDA for traditional approval was completed last quarter, with regulatory action expected by the end of the year.

As previously reported, among participants with low-medium levels of tau (n=1182), donanemab treatment significantly slowed decline by 35% on iADRS and 36% on CDR-SB.

Among all amyloid-positive early symptomatic AD study participants (n=1736), treatment with donanemab significantly slowed decline by 22% on iADRS and 29% on CDR-SB.

In participants with mild cognitive impairment (n=214), donanemab slowed decline by 60% on iADRS and 46% on CDR-SB (for those with mild dementia due to AD, n=534, donanemab slowed decline by 30% on iADRS and 38% on CDR-SB, respectively).

In participants under 75 (n=542), donanemab slowed the decline by 48% on iADRS and 45% on CDR-SB.

In participants aged 75 or greater (n=551), donanemab slowed the decline by 25% on iADRS and 29% on CDR-SB.

In participants with low-medium tau, treatment with donanemab resulted in 47% of participants with no progression at one year on the CDR-SB assessment versus 29% on placebo.

Those participants treated with donanemab also had a 39% lower risk of progressing over the 18-month trial.

Price Action: LLY shares are down 0.63% at $446.63 on the last check Monday.