Sage Therapeutics, Inc. (SAGE) has received some disappointing news from its partner, Biogen (BIIB). Biogen has terminated its rights related to SAGE-324, an investigational neurology candidate, effective February 17, 2025. This decision follows the failure of a Phase II study on SAGE-324 for treating essential tremor, which did not meet its primary endpoint in July.
Despite this setback, Sage Therapeutics will regain full ownership and rights to SAGE-324. The company plans to explore potential alternative indications for the drug.
The termination of the deal marks a significant shift for both companies. While Sage Therapeutics faces a setback in its essential tremor treatment efforts, it also gains the opportunity to explore new avenues for SAGE-324. Biogen, on the other hand, focuses on other neurological and rare disease treatments.
Sage Therapeutics remains optimistic about its other collaborations with Biogen, particularly in the area of depression treatment. The company currently markets the depression drug Zurzuvae (zuranolone) in partnership with Biogen. Zurzuvae, approved by the FDA in August 2023, is the first and only oral treatment indicated for adults with postpartum depression (PPD).
Sage Therapeutics and Biogen share profits and losses for Zurzuvae’s commercialization in the U.S. In other markets, Biogen handles product sales (excluding Japan, Taiwan, and South Korea) and pays royalties to Sage Therapeutics. The companies are committed to establishing Zurzuvae as a leading therapy for women with PPD.
However, Sage Therapeutics is facing challenges with Zurzuvae’s potential use for treating major depressive disorder. The FDA issued a complete response letter (CRL) in August 2023, indicating that the data presented for a new drug application (NDA) did not provide sufficient evidence of effectiveness for approval. The FDA recommended conducting further clinical studies. Sage Therapeutics is currently evaluating the necessary steps to address the CRL.
This development underscores the complexities of the pharmaceutical industry and the inherent risks associated with clinical trials. While setbacks are a part of the process, the companies continue to innovate and strive for breakthrough treatments. The future remains uncertain for Sage Therapeutics and its pipeline of neurological and psychiatric treatments, but the company remains committed to developing effective therapies for patients in need.
