Sage Therapeutics

Sage Therapeutics' lead therapeutic asset, dalzanemdor, failed a Phase II trial for Huntington's disease, leading to discontinuation of its development. This marks the third mid-stage failure for the company, which has seen its stock value drop by over 90% in the past year and a half. Sage's pipeline is now limited, with only one commercial product, Zurzuvae, generating revenue. The company has undergone significant restructuring and layoffs to focus on Zurzuvae's commercialization, but its path to profitability remains uncertain.

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Cerevance’s phase 3 ARISE trial for Parkinson disease has begun dosing with solengepras. Sage Therapeutics discontinued SAGE-718 development after phase 2 DIMENSION study failed to meet end points in Huntington Disease. Neurogene paused high-dose NGN-401 use in Rett syndrome trial due to a serious adverse event.

Sage Therapeutics' Phase II DIMENSION study for dalzanemdor (SAGE-718) failed to meet primary and secondary endpoints in treating cognitive impairment in Huntington’s disease patients, leading to the discontinuation of its development.

Huntington's disease treatments face challenges due to rarity and trial failures, but recent milestones like Wave's WVE-003, Roche-Ionis' tominersen, uniQure's AMT-130, and PTC Therapeutics' PTC518 offer hope. Prilenia's pridopidine is under EMA review, while Annexon's ANX005 and Sage's dalzanemdor faced setbacks. Despite these, cautious optimism remains for effective treatments.

Cybin's CYB003, a deuterated psilocin drug for MDD, showed 12-month efficacy with 100% response rate and 71% sustained remission. The FDA's Breakthrough Therapy Designation supports its potential over existing therapies, with no new adverse events reported. Cybin plans to launch Phase 3 PARADIGM program for global efficacy and safety assessment.

Sage ends dalzanemdor development after Phase II Huntington’s disease trial failure, leaving one commercial drug and three early-stage assets.

Sage Therapeutics halts dalzanemdor development for HD, disappointing the community. HD affects cognition beyond motor symptoms, with new tests like HD-CAB measuring cognitive changes. Dalzanemdor aimed to amplify brain messages for improved cognition but failed to meet clinical endpoints in trials for Parkinson’s, Alzheimer’s, and HD. The DIMENSION study, testing dalzanemdor in HD, also failed, prompting Sage to halt further development. Despite setbacks, trials provide valuable data and insights for future drug development, and over 60 companies continue to work on HD treatments.

Sage Therapeutics halts development of SAGE-718 after failing mid-stage study for Huntington's disease, leaving a bare research pipeline. The company plans restructuring, including layoffs and reprioritization of early-stage projects, following setbacks with SAGE-324 and Zurzuvae. Shares have plummeted, and future profitability remains uncertain.