This section highlights FDA-related milestones and regulatory updates for drugs developed by Sage Therapeutics (SAGE).
Over the past two years, Sage Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SAGE-324 and SAGE-718. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SAGE-324 (BIIB124) - FDA Regulatory Timeline and Events
SAGE-324 (BIIB124) is a drug developed by Sage Therapeutics for the following indication: For the Treatment of Essential Tremor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SAGE-324 (BIIB124)
- Announced Date:
- July 24, 2024
- Indication:
- For the Treatment of Essential Tremor
Announcement
Sage Therapeutics, Inc. and Biogen Inc. announced topline results from the Phase 2 KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET).
AI Summary
Sage Therapeutics and Biogen recently announced top-line results from the Phase 2 KINETIC 2 dose-range study evaluating SAGE-324 (BIIB124) as a potential treatment for essential tremor (ET). The study compared multiple doses of the drug with a placebo over a three‐month period, and the main goal was to assess changes in tremor severity using the Essential Tremor Rating Assessment Scale’s Performance Subscale.
The results showed no statistically significant dose-response relationship, and there were no significant differences between any SAGE-324 dose and placebo on the primary endpoint. As a result, both companies have decided to close the ongoing open-label safety study for ET and will not continue clinical development of SAGE-324 in this condition. Future development may focus on exploring other potential indications.
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SAGE-718 - FDA Regulatory Timeline and Events
SAGE-718 is a drug developed by Sage Therapeutics for the following indication: In the Treatment of Mild Cognitive Impairment in Parkinson's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SAGE-718
- Announced Date:
- November 20, 2024
- Indication:
- In the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Announcement
Sage Therapeutics, Inc announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Huntington's Disease (HD).
AI Summary
Sage Therapeutics recently released topline results from the Phase 2 DIMENSION Study evaluating dalzanemdor (SAGE-718) in participants with cognitive impairment linked to Huntington’s disease. The study, which lasted 12 weeks and included 189 participants in a double-blind, placebo-controlled trial, did not achieve its primary endpoint. Specifically, dalzanemdor failed to show a statistically significant improvement on the Symbol Digit Modalities Test (SDMT) at Day 84 compared to placebo. Additionally, secondary endpoint analyses did not reveal any meaningful differences between the dalzanemdor and placebo groups. Despite being generally well-tolerated and presenting only mild to moderate side effects without new safety issues, these results have led Sage Therapeutics to discontinue further development of dalzanemdor. This decision reflects the company’s commitment to prioritizing effective treatment options and reallocating resources toward other promising research areas in brain health.
Read Announcement- Drug:
- SAGE-718
- Announced Date:
- October 8, 2024
- Indication:
- In the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Announcement
Sage Therapeutics, Inc announced topline results from LIGHTWAVE, a 12-week, Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor (SAGE-718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD).
AI Summary
Sage Therapeutics, Inc. recently announced topline results from the LIGHTWAVE study, a 12-week Phase 2 randomized, double-blind, placebo-controlled trial that evaluated the effects of dalzanemdor (SAGE‑718) in participants with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s Disease. The primary outcome, based on the WAIS‑IV Coding Test score at Day 84, did not show a statistically significant improvement from baseline when comparing dalzanemdor with placebo. Although the drug was generally well‑tolerated and no new safety signals were observed, the results did not support further development of dalzanemdor for Alzheimer’s Disease.
Sage Therapeutics now plans to focus on additional research in Huntington’s Disease, with topline data from the Phase 2 DIMENSION Study expected later this year, as the company continues its search for effective treatments for cognitive impairments.
Read Announcement- Drug:
- SAGE-718
- Announced Date:
- June 11, 2024
- Indication:
- In the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Announcement
Sage Therapeutics announced The study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington's Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo.
AI Summary
Sage Therapeutics announced topline results from its Phase 2 SURVEYOR Study aimed at assessing cognitive differences in Huntington’s Disease (HD). The study met its primary endpoint by showing a statistically significant difference in the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and those with HD before any treatment was given. This finding underlines the substantial cognitive impairment in HD patients compared to healthy individuals.
In the second part of the study, participants with HD were treated with either dalzanemdor (SAGE-718) or placebo over a 28‐day period. Dalzanemdor was generally well-tolerated, with no new safety concerns observed. These results highlight the urgent need for treatment options that address cognitive deficits in HD and support further research into the potential benefits of dalzanemdor.
Read Announcement- Drug:
- SAGE-718
- Announced Date:
- June 11, 2024
- Indication:
- In the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Announcement
Sage Therapeutics announced today topline results from the Phase 2 SURVEYOR Study.
AI Summary
Sage Therapeutics today announced topline results from the Phase 2 SURVEYOR Study focused on cognitive impairment in Huntington’s Disease (HD). The study met its primary endpoint by showing a statistically significant difference in the HD-Cognitive Assessment Battery (HD-CAB) composite scores at baseline when comparing healthy participants to those with HD. This result emphasizes the substantial cognitive challenges faced by individuals with HD before any treatment. In the second part of the study, participants with HD received either dalzanemdor (SAGE-718) or placebo. Dalzanemdor was generally well-tolerated, with no new safety signals reported, suggesting the treatment is safe for this population. These findings underscore the urgent need for treatments that address the cognitive aspects of HD and support further research into dalzanemdor’s potential benefits for individuals living with this challenging condition.
Read Announcement- Drug:
- SAGE-718
- Announced Date:
- April 17, 2024
- Indication:
- In the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Announcement
Sage Therapeutics, Inc. announced topline results from PRECEDENT, a double-blind, placebo-controlled Phase 2 study of the investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson's Disease (PD).
AI Summary
Sage Therapeutics recently announced topline results from the PRECEDENT study, a Phase 2, double-blind, placebo-controlled trial evaluating the investigational oral medication dalzanemdor (SAGE‑718) in people with mild cognitive impairment in Parkinson’s disease. The study did not meet its primary endpoint, as dalzanemdor did not show statistically significant improvement over placebo on the WAIS‑IV Coding Test at Day 42.
Despite this outcome, the medicine was generally well-tolerated, and no new safety signals were observed during the trial. Sage Therapeutics expressed disappointment in the results, noting the significant impact of cognitive decline on patients and families. They emphasized that these findings are specific to Parkinson’s disease and do not necessarily reflect the drug’s potential in other neurodegenerative conditions. Topline data from Phase 2 studies in Huntington’s and Alzheimer’s diseases are expected later this year.
Read Announcement- Drug:
- SAGE-718
- Announced Date:
- April 17, 2024
- Indication:
- In the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Announcement
Sage Therapeutics, Inc announced that Topline data readouts from the Phase 2 studies in Huntington's disease and Alzheimer's disease are expected later this year
AI Summary
Sage Therapeutics announced recent topline results from its Phase 2 PRECEDENT study in people with mild cognitive impairment related to Parkinson’s disease. Although the study did not meet its primary endpoint of showing significant improvements compared to placebo, the drug dalzanemdor (SAGE-718) was generally well-tolerated and no new safety concerns were observed.
Looking ahead, the company is turning its focus toward other neurodegenerative diseases. Sage Therapeutics expects topline data readouts from its ongoing Phase 2 studies in Huntington’s disease and Alzheimer’s disease later this year. These forthcoming results will be important in determining the potential of dalzanemdor for treating cognitive symptoms in these conditions and will help guide the future direction of the drug’s development program.
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