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SAGE.US
id: 1545
Sage Therapeutics ($SAGE) Failed Drug Launch and Misleading FDA Guidance Case
S.D. New York
Court1:25-cv-02498
Case number04/12/2021
Class period Start07/23/2024
Class period End05/27/2025
Lead Plaintiff motion deadline- $SAGE investors filed a lawsuit against Sage Therapeutics for misleading statements about its drug pipeline, including zuranolone, and the likelihood of FDA approval.
- After announcing the rejection of zuranolone for MDD and cutting its pipeline, $SAGE dropped 53.6% in just three days.
- $SAGE investors can join this case to be notified about potential recovery.
Case Details:
Between April 12, 2021, and July 23, 2024, Sage Therapeutics promoted its drug zuranolone as a key treatment for major depressive disorder (MDD) and postpartum depression (PPD). Executives consistently assured investors that zuranolone’s clinical data supported FDA approval for both uses and emphasized the drug’s long-term potential.
But on August 4, 2023, Sage announced that while the FDA approved zuranolone for PPD, it rejected the application for MDD, citing concerns about sustained efficacy and safety. Since MDD had been presented as zuranolone’s primary market opportunity, the news triggered a sharp selloff. $SAGE fell 53.6% in just three days.
Less than a year later, in July 2024, Sage announced it would halt development of two other pipeline drugs—SAGE-718 and SAGE-324— after disappointing trial results. These back-to-back failures raised serious concerns about the company's drug development strategy and prior disclosures.
Based on these events, $SAGE investors filed a lawsuit against Sage Therapeutics, claiming the company:
- It misled investors about zuranolone’s chances of approval for MDD and downplayed regulatory risks.
- It overstated the commercial potential of SAGE-718 and SAGE-324.
- It concealed internal setbacks that led to major product failures.
Investors believe Sage withheld key risks about its pipeline to maintain investor confidence.
Case Status
Lead Plaintiff Appointment
Alleged Offence
Misleading Statements,
Breach of Fiduciary duty
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
07/24/2024
Filing date
03/26/2025
Lead Plaintiff Deadline
05/27/2025