Sage Therapeutics is undergoing a significant restructuring, including laying off approximately one-third of its workforce and reprioritizing its early-stage drug pipeline. This decision comes after a series of clinical and regulatory challenges, impacting the company's prospects and necessitating a strategic realignment.
The restructuring involves the departure of five senior executives and will affect approximately 165 employees, with over half from the research division. Sage expects to complete the reorganization by the end of the current quarter, aiming to extend its operating runway.
Zurzuvae's Limited Approval and Market Performance
Last year, Sage and its partner Biogen secured FDA approval for Zurzuvae (zuranolone) for postpartum depression. However, the FDA declined approval for major depressive disorder (MDD) following mixed clinical trial results. This narrower-than-anticipated approval has limited Zurzuvae's market potential. Despite this, prescriptions for the drug increased by over 60% in the second quarter of 2024, with total sales reaching approximately $15 million.
Zurzuvae, a neuroactive steroid (NAS) gamma-aminobutyric acid type A (GABA-A) receptor-positive allosteric modulator, is designed to regulate mood and behavior. GlobalData forecasts predict Zurzuvae will generate $607 million in sales by 2030.
Clinical Trial Failures and Pipeline Reprioritization
Sage has faced recent setbacks in its pipeline development. Dalzanemdor, an experimental drug, failed to demonstrate improvement in mental function compared to placebo in a Phase 2 study for Parkinson's disease. Subsequently, it also fell short in a trial involving individuals with mild dementia due to Alzheimer's disease. Consequently, Sage has decided to discontinue its development for Alzheimer's.
"Sage has navigated choppy waters of late," noted a recent report, highlighting the impact of these clinical failures on the company's strategic direction.
Another Sage drug, licensed to Biogen, also failed in a mid-stage study for essential tremors over the summer.
Sage's remaining hopes for dalzanemdor rest on the Phase II DIMENSION study for Huntington's disease, with data expected by late 2024. The company will now focus its resources on launching Zurzuvae and advancing dalzanemdor for Huntington's disease.
Financial Impact and Future Outlook
The restructuring is intended to allocate available resources towards supporting the commercial launch of Zurzuvae. Sage anticipates incurring costs of $26-28 million in Q4 2024 related to the reorganization. This move aims to strengthen the company’s financial and long-term operational positions, providing flexibility to address immediate priorities.
