| Drug / Therapy | SAGE-718 |
| Indication | Huntington's disease cognitive impairment |
| Decision Type | PDUFA |
| Conditions | Huntington's disease cognitive impairment |
| Interventions | SAGE-718 |
Sage Therapeutics (SAGE) operates in the Neuroscience sector. The current BTS Score is 50 (Grade: C).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The PDUFA date for SAGE-718 by Sage Therapeutics (SAGE) is scheduled for August 18, 2026. This is the target date for the FDA to make a decision on this application.
SAGE-718 is being developed by Sage Therapeutics for the treatment of Huntington's disease cognitive impairment. It is under FDA review.
If SAGE-718 receives FDA approval, Sage Therapeutics (SAGE) would be able to market the drug in the United States for Huntington's disease cognitive impairment. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for SAGE on DilutionWatch at dilutionwatch.com/stock/SAGE.html.
You can view the full BiotechSigns company profile for Sage Therapeutics (SAGE) at biotechsign.com/app/company/SAGE, which includes the BTS Score, signal history, clinical trial data, and insider trading activity.
This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSigns is not a registered investment advisor.