The European Commission cleared its Alzheimer’s drug Kisunla, adding another country to the company’s list where the once-monthly therapy is approved.
Eli Lilly’s stock rose over 1% in pre-market trading on Friday after the European Commission cleared its Alzheimer’s drug Kisunla (donanemab) for use in patients with early symptoms of the disease.
The approval applies to adults with mild cognitive impairment or mild dementia caused by Alzheimer’s who test positive for amyloid buildup and are either ApoE4 heterozygotes or non-carriers.
The TRAILBLAZER-ALZ 2 trial demonstrated that Kisunla slowed disease progression and helped preserve cognitive function, while long-term data suggested that it reduced the risk of advancing to the next disease stage over 18 months.
Lilly said Kisunla is the only amyloid plaque-targeting therapy with evidence supporting treatment completion once amyloid levels are minimized, potentially lowering costs and infusion burden.
Kisunla, already approved in the U.S., Japan, China, the U.K., and other countries, is given once monthly via intravenous infusion. In the EU, the drug is limited to ApoE4 heterozygotes or non-carriers, unlike approvals in some other regions.
Eli Lilly also notched another regulatory win on Thursday after the U.S. Food and Drug Administration approved Inluriyo, its therapy for advanced breast cancer in adults who have already undergone prior treatment.
Lilly’s position also looks more resilient as President Donald Trump unveiled a 100% tariff on branded and patented drugs imported into the U.S. beginning Oct. 1. The policy exempts companies with manufacturing underway in the U.S., which supports Lilly, given its extensive domestic production footprint and investment in American facilities.
On Stocktwits, retail sentiment for Eli Lilly was ‘bullish’ amid ‘high’ message volume.
One user suggested that even with the European Commission’s approval of Kisunla, the stock appeared to be pushed lower during early, low-volume trading, allowing investors to accumulate shares at cheaper levels.
Another user noted their satisfaction at timing the move, saying they were glad to have picked up 150 shares of Eli Lilly during the dip.
Eli Lilly’s stock has declined 6.9% so far in 2025.
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