Sage Therapeutics’ SAGE phase II study evaluating its neuropsychiatric candidate, dalzanemdor (SAGE-718), for treating cognitive impairment (CI) associated with Huntington’s Disease (HD) failed to meet the primary endpoint.
The double-blind, placebo-controlled DIMENSION study evaluated the effects of dalzanemdor in participants with CI associated with HD.
Top-line data from the study showed that dalzanemdor failed to demonstrate a statistically significant difference from baseline compared to placebo on the Symbol Digit Modalities Test, a measure of cognitive function, at day 84. This was the primary endpoint of the study.
The stock hit its 52-week low on the pipeline setback. Year to date, shares of Sage Therapeutics have plunged 77.3% compared with the industry’s decline of 8.5%.
Image Source: Zacks Investment Research
More on SAGE's DIMENSION Study
The analyses of secondary endpoints from the DIMENSION study also failed to demonstrate statistically significant or clinically meaningful differences in patients treated with dalzanemdor versus placebo.
Treatment with dalzanemdor was generally well-tolerated and no new safety signals were reported.
Following the disappointing data from the DIMENSION study, SAGE decided to stop further development of dalzanemdor.
The company also decided to stop the ongoing PURVIEW study, which is an open-label safety study evaluating dalzanemdor for treating participants with HD.
An inherited disorder, HD, causes nerve cells (neurons) in brain parts to gradually break down and die. CI is one of the most under-recognized aspects of HD. Currently, no treatment options are available to improve HD-related cognitive effects.
SAGE's Earlier Setback in the Development of Dalzanemdor
Last month, Sage Therapeutics announced that the phase II LIGHTWAVE study, which evaluated dalzanemdor for treating mild cognitive impairment (MCI) and mild dementia in Alzheimer’s Disease (AD), failed to meet the primary endpoint.
Following this, the company decided to stop further development of dalzanemdor for the AD indication.
Previously, dalzanemdor failed in the phase II PRECEDENT study, which investigated the candidate in patients with MCI associated with Parkinson’s disease (PD).
SAGE has stopped further development of dalzanemdor for the PD indication as well.
Owing to the string of pipeline setbacks related to the development of dalzanemdor, SAGE decided to stop the development of the candidate for all the indications.
SAGE's Zacks Rank & Key Picks
Sage Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.6%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 18.3%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 31.8%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
Research Chief Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
This company targets millennial and Gen Z audiences, generating nearly $1 billion in revenue last quarter alone. A recent pullback makes now an ideal time to jump aboard. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.
Free: See Our Top Stock And 4 Runners UpSage Therapeutics, Inc. (SAGE) : Free Stock Analysis Report
Spero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report
Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report
Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report
To read this article on Zacks.com click here.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
