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ATHA Stock Tanks as Alzheimer's Study Fails to Meet Primary Goal
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Shares of Athira Pharma, Inc. (ATHA - Free Report) plunged 72.2% in after-hours trading on Sep 3 after the company announced disappointing top-line data from the phase II/III LIFT-AD study evaluating its pipeline candidate, fosgonimeton, for the treatment of mild-to-moderate Alzheimer’s disease (AD).
The LIFT-AD study investigated once-daily fosgonimeton (40 mg) subcutaneous injection versus placebo over a treatment period of 26 weeks in mild-to-moderate AD patients.
The study did not meet the primary endpoint which was the Global Statistical Test (GST), a combination of results from measures of cognition and function.
The study also failed to meet the key secondary endpoints of changes in cognition and function, plasma biomarkers of neurodegeneration, protein pathology and neuroinflammation.
Shares of Athira have increased 16.4% so far this year compared with the industry’s growth of 0.6%.
Image Source: Zacks Investment Research
However, in pre-specified subgroups of patients with moderate AD or who are carriers of the APOE4 gene, cognition and function improved or stabilized in patients who received fosgonimeton compared to placebo.
Also, in prespecified biomarker analyses, cognition and function, the two key measures of GST, directionally favored treatment with fosgonimeton over placebo.
Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain.
Fosgonimeton, a potentially first-in-class, small molecule drug candidate, is designed to modulate the neurotrophic hepatocyte growth factor system to protect and maintain neuronal health and function in Alzheimer’s disease patients.
Other Players in the AD Market
Biogen (BIIB - Free Report) and partner Eisai’s Leqembi was approved by the FDA for early AD in the United States in July 2023.
BIIB believes Leqembi has the potential to generate blockbuster sales as there remains a massive unmet need for AD.
In July 2024, the FDA approved Eli Lilly’s (LLY - Free Report) Kisunla (donanemab) for treating early symptomatic AD in the United States.
LLY’s Kisunla is the second drug on the market to treat AD, the first being Leqembi.
Apart from LLY and BIIB, several other companies like Prothena Corporation, AC Immune and Cassava Sciences are also developing their respective therapies for Alzheimer's disease.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
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ATHA Stock Tanks as Alzheimer's Study Fails to Meet Primary Goal
Shares of Athira Pharma, Inc. (ATHA - Free Report) plunged 72.2% in after-hours trading on Sep 3 after the company announced disappointing top-line data from the phase II/III LIFT-AD study evaluating its pipeline candidate, fosgonimeton, for the treatment of mild-to-moderate Alzheimer’s disease (AD).
The LIFT-AD study investigated once-daily fosgonimeton (40 mg) subcutaneous injection versus placebo over a treatment period of 26 weeks in mild-to-moderate AD patients.
The study did not meet the primary endpoint which was the Global Statistical Test (GST), a combination of results from measures of cognition and function.
The study also failed to meet the key secondary endpoints of changes in cognition and function, plasma biomarkers of neurodegeneration, protein pathology and neuroinflammation.
Shares of Athira have increased 16.4% so far this year compared with the industry’s growth of 0.6%.
Image Source: Zacks Investment Research
However, in pre-specified subgroups of patients with moderate AD or who are carriers of the APOE4 gene, cognition and function improved or stabilized in patients who received fosgonimeton compared to placebo.
Also, in prespecified biomarker analyses, cognition and function, the two key measures of GST, directionally favored treatment with fosgonimeton over placebo.
Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain.
Fosgonimeton, a potentially first-in-class, small molecule drug candidate, is designed to modulate the neurotrophic hepatocyte growth factor system to protect and maintain neuronal health and function in Alzheimer’s disease patients.
Other Players in the AD Market
Biogen (BIIB - Free Report) and partner Eisai’s Leqembi was approved by the FDA for early AD in the United States in July 2023.
BIIB believes Leqembi has the potential to generate blockbuster sales as there remains a massive unmet need for AD.
In July 2024, the FDA approved Eli Lilly’s (LLY - Free Report) Kisunla (donanemab) for treating early symptomatic AD in the United States.
LLY’s Kisunla is the second drug on the market to treat AD, the first being Leqembi.
Apart from LLY and BIIB, several other companies like Prothena Corporation, AC Immune and Cassava Sciences are also developing their respective therapies for Alzheimer's disease.
Zacks Rank & Another Stock to Consider
Athira currently carries a Zacks Rank #2 (Buy).
A top-ranked stock in the biotech sector is Illumina, Inc. (ILMN - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.