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SAGE's Dalzanemdor Fails to Meet Goal in Alzheimer's Disease Study
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Shares of Sage Therapeutics, Inc. (SAGE - Free Report) were down 4.3% on Oct. 8 after the company announced disappointing top-line data from the phase II LIGHTWAVE study, which evaluated its neuropsychiatric candidate, dalzanemdor (SAGE-718) for treating mild cognitive impairment (MCI) and mild dementia in Alzheimer’s Disease (AD). The stock continued to lose another 2.8% in the after-market hours.
The double-blind, placebo-controlled LIGHTWAVE study evaluated the effects of dalzanemdor in participants with MCI or mild dementia due to AD.
Data from the study showed that treatment with dalzanemdor failed to demonstrate a statistically significant difference from baseline as compared to placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at day 84. This was the primary endpoint of the 12-week LIGHTWAVE study.
Year to date, shares of Sage Therapeutics have plunged 70.3% compared with the industry’s decline of 5.2%.
Image Source: Zacks Investment Research
Per management, the analyses of data from the LIGHTWAVE study also did not indicate any meaningful differences versus placebo in the other exploratory endpoints, such as RBANS total score or MoCA total score. Treatment with dalzanemdor was generally well-tolerated and no new safety signals were reported.
Following the disappointing data from the LIGHTWAVE study, SAGE decided to stop further development of dalzanemdor in AD.
SAGE's Earlier Setback in Parkinson's Study
In April 2024, Sage Therapeutics reported top-line data from the phase II PRECEDENT study, which investigated dalzanemdor in patients with MCI associated with Parkinson’s disease (PD).
The study failed to achieve its primary endpoint of demonstrating a statistically significant difference from baseline in participants treated with dalzanemdor compared to placebo. Per the company, the analyses of data also did not indicate any meaningful differences versus placebo in the other exploratory endpoints, such as SCOPA-Cog.
Back then, management also pointed out that more than half of the total study participants experienced treatment-emergent adverse events (TEAEs) ranging from mild to moderate in severity.
Based on these results, SAGE decided not to pursue the development of dalzanemdor in PD indication.
SAGE's Other Study on Dalzanemdor
Dalzanemdor is currently being evaluated as a potential treatment for patients with cognition dysfunction associated with Huntington’s disease (HD) across three ongoing clinical studies – two phase II studies (DIMENSION and SURVEYOR) and a phase III study (PURVIEW).
Top-line data from the phase II DIMENSION study is expected later this year.
In June 2024, SAGE announced that the phase II SURVEYOR study evaluating dalzanemdor as a potential treatment for patients with cognition dysfunction caused by HD met its primary endpoint.
Now that Sage Therapeutics has faced a couple of setbacks with the AD and PD indications for dalzanemdor, the successful development of the candidate for the HD indication remains the key focus area for the company.
SAGE's Rank & Stocks to Consider
Sage Therapeutics currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.69 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have increased 3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have increased from 35 cents to 49 cents. Earnings per share estimates for 2025 have improved from 53 cents to 64 cents. Year to date, shares of ADMA have surged 358.4%.
ADMA’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 105.63%.
In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 cents to 27 cents. Year to date, shares of ALNY have rallied 41.7%.
ALNY’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 108.53%.
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SAGE's Dalzanemdor Fails to Meet Goal in Alzheimer's Disease Study
Shares of Sage Therapeutics, Inc. (SAGE - Free Report) were down 4.3% on Oct. 8 after the company announced disappointing top-line data from the phase II LIGHTWAVE study, which evaluated its neuropsychiatric candidate, dalzanemdor (SAGE-718) for treating mild cognitive impairment (MCI) and mild dementia in Alzheimer’s Disease (AD). The stock continued to lose another 2.8% in the after-market hours.
The double-blind, placebo-controlled LIGHTWAVE study evaluated the effects of dalzanemdor in participants with MCI or mild dementia due to AD.
Data from the study showed that treatment with dalzanemdor failed to demonstrate a statistically significant difference from baseline as compared to placebo on the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test score at day 84. This was the primary endpoint of the 12-week LIGHTWAVE study.
Year to date, shares of Sage Therapeutics have plunged 70.3% compared with the industry’s decline of 5.2%.
Image Source: Zacks Investment Research
Per management, the analyses of data from the LIGHTWAVE study also did not indicate any meaningful differences versus placebo in the other exploratory endpoints, such as RBANS total score or MoCA total score. Treatment with dalzanemdor was generally well-tolerated and no new safety signals were reported.
Following the disappointing data from the LIGHTWAVE study, SAGE decided to stop further development of dalzanemdor in AD.
SAGE's Earlier Setback in Parkinson's Study
In April 2024, Sage Therapeutics reported top-line data from the phase II PRECEDENT study, which investigated dalzanemdor in patients with MCI associated with Parkinson’s disease (PD).
The study failed to achieve its primary endpoint of demonstrating a statistically significant difference from baseline in participants treated with dalzanemdor compared to placebo. Per the company, the analyses of data also did not indicate any meaningful differences versus placebo in the other exploratory endpoints, such as SCOPA-Cog.
Back then, management also pointed out that more than half of the total study participants experienced treatment-emergent adverse events (TEAEs) ranging from mild to moderate in severity.
Based on these results, SAGE decided not to pursue the development of dalzanemdor in PD indication.
SAGE's Other Study on Dalzanemdor
Dalzanemdor is currently being evaluated as a potential treatment for patients with cognition dysfunction associated with Huntington’s disease (HD) across three ongoing clinical studies – two phase II studies (DIMENSION and SURVEYOR) and a phase III study (PURVIEW).
Top-line data from the phase II DIMENSION study is expected later this year.
In June 2024, SAGE announced that the phase II SURVEYOR study evaluating dalzanemdor as a potential treatment for patients with cognition dysfunction caused by HD met its primary endpoint.
Now that Sage Therapeutics has faced a couple of setbacks with the AD and PD indications for dalzanemdor, the successful development of the candidate for the HD indication remains the key focus area for the company.
SAGE's Rank & Stocks to Consider
Sage Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , ADMA Biologics, Inc. (ADMA - Free Report) and Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) , each 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 ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.69 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have increased 3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have increased from 35 cents to 49 cents. Earnings per share estimates for 2025 have improved from 53 cents to 64 cents. Year to date, shares of ADMA have surged 358.4%.
ADMA’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 105.63%.
In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per share estimates for 2025 have narrowed from 34 cents to 27 cents. Year to date, shares of ALNY have rallied 41.7%.
ALNY’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 108.53%.