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LLY Gets EU Approval for Alzheimer's Drug & FDA Nod to Cancer Therapy
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Key Takeaways
{\"0\":\"Eli Lilly won EU marketing approval for Kisunla to treat early symptomatic Alzheimer\'s disease.\",\"1\":\"The approval was backed by TRAILBLAZER studies showing Kisunla slowed cognitive and functional decline.\",\"2\":\"The FDA also clears Inluriyo for ER , HER2- breast cancer with ESR1 mutations after prior endocrine therapy.\"}
Eli Lilly and Company (LLY - Free Report) announced that the European Commission (EC) has granted marketing authorization to Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD).
Kisunla is now approved in the European Union for treating early symptomatic AD in adults with mild cognitive impairment (MCI), as well as those with the mild dementia stage of AD, with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
The EU nod was based on data from two late-stage studies, TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6.
Data from the phase III TRAILBLAZER-ALZ 2 study showed that treatment with Kisunla significantly slowed cognitive and functional decline. The dosing will be based on the phase IIIb TRAILBLAZER-ALZ 6 study.
Per management, treatment with Kisunla slows disease progression, which may help patients in preserving cognitive function and independence longer.
Year to date, shares of Eli Lilly have declined 7.4% compared with the industry’s decrease of 0.5%.
Image Source: Zacks Investment Research
Marketed Drugs in the AD Space
Besides Kisunla, another drug approved by the FDA in the AD space is Leqembi, which is developed by Biogen (BIIB - Free Report) /Eisai and was initially approved by the FDA in 2023. Leqembi is also approved in the European Union.
Both Biogen/Eisai’s Leqembi and Lilly’s Kisunla are approved to treat early symptomatic AD, which includes mild cognitive impairment or the dementia stage of the disease. The Biogen/Eisai and Lilly drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD.
Alzheimer’s disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Donanemab is an Aβ targeting therapy. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD.
LLY’s Kisunla has been experiencing a rapid uptake. In the first half of 2025, Kisunla recorded sales worth $70.1 million as the new drug saw a steady launch trajectory.
LLY Gets FDA Nod for Inluriyo
In a separate press release, Eli Lilly announced that the FDA has approved Inluriyo (imlunestrant), an oral estrogen receptor antagonist, for a breast cancer indication.
The regulatory body in the United States approved Inluriyo (200 mg tablets) for treating adult patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.
The company plans to launch Inluriyo in the United States in the coming weeks.
The latest FDA nod was based on data from the phase III EMBER-3 study. Data from the same showed that treatment with Inluriyo monotherapy reduced the risk of progression or death by 38% compared to in patients with ESR1 mutations.
Notably, the Inluriyo label contains a warning and precaution for embryo-fetal toxicity.
Inluriyo is also being evaluated in the phase III EMBER-4 study in the adjuvant setting for treating patients with ER+, HER2– early breast cancer.
LLY’s Zacks Rank & Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.74. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 66.1% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 119% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.
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LLY Gets EU Approval for Alzheimer's Drug & FDA Nod to Cancer Therapy
Key Takeaways
Eli Lilly and Company (LLY - Free Report) announced that the European Commission (EC) has granted marketing authorization to Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD).
Kisunla is now approved in the European Union for treating early symptomatic AD in adults with mild cognitive impairment (MCI), as well as those with the mild dementia stage of AD, with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
The EU nod was based on data from two late-stage studies, TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6.
Data from the phase III TRAILBLAZER-ALZ 2 study showed that treatment with Kisunla significantly slowed cognitive and functional decline. The dosing will be based on the phase IIIb TRAILBLAZER-ALZ 6 study.
Per management, treatment with Kisunla slows disease progression, which may help patients in preserving cognitive function and independence longer.
The FDA approved Kisunla for treating early symptomatic AD last year. The drug is also approved in Japan, China, the United Kingdom and several other countries.
LLY’s Price Performance
Year to date, shares of Eli Lilly have declined 7.4% compared with the industry’s decrease of 0.5%.
Image Source: Zacks Investment Research
Marketed Drugs in the AD Space
Besides Kisunla, another drug approved by the FDA in the AD space is Leqembi, which is developed by Biogen (BIIB - Free Report) /Eisai and was initially approved by the FDA in 2023. Leqembi is also approved in the European Union.
Both Biogen/Eisai’s Leqembi and Lilly’s Kisunla are approved to treat early symptomatic AD, which includes mild cognitive impairment or the dementia stage of the disease. The Biogen/Eisai and Lilly drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD.
Alzheimer’s disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Donanemab is an Aβ targeting therapy. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD.
LLY’s Kisunla has been experiencing a rapid uptake. In the first half of 2025, Kisunla recorded sales worth $70.1 million as the new drug saw a steady launch trajectory.
LLY Gets FDA Nod for Inluriyo
In a separate press release, Eli Lilly announced that the FDA has approved Inluriyo (imlunestrant), an oral estrogen receptor antagonist, for a breast cancer indication.
The regulatory body in the United States approved Inluriyo (200 mg tablets) for treating adult patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.
The company plans to launch Inluriyo in the United States in the coming weeks.
The latest FDA nod was based on data from the phase III EMBER-3 study. Data from the same showed that treatment with Inluriyo monotherapy reduced the risk of progression or death by 38% compared to in patients with ESR1 mutations.
Notably, the Inluriyo label contains a warning and precaution for embryo-fetal toxicity.
Inluriyo is also being evaluated in the phase III EMBER-4 study in the adjuvant setting for treating patients with ER+, HER2– early breast cancer.
LLY’s Zacks Rank & Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.74. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 66.1% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 119% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.