Zinger Key Points
- Sage will regain full ownership of SAGE-324 after Biogen terminates their collaboration following disappointing study results.
- The companies will continue to collaborate on Zurzuvae, the FDA-approved treatment for postpartum depression.
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On Thursday, Sage Therapeutics Inc. SAGE announced that Biogen Inc BIIB had terminated its rights under the collaboration and license agreement with Sage, which was specific to the SAGE-324 program.
The companies recently announced negative results from the Phase 2 KINETIC 2 Study of investigational SAGE-324 for the chronic treatment of essential tremor (ET) and discontinued further clinical development of SAGE-324 in ET.
Essential tremor is a neurological disorder that causes involuntary shaking or trembling in certain body parts.
In July, the companies announced results from the Phase 2 KINETIC 2 dose-range study of SAGE-324 (BIIB124) as a potential treatment for essential tremor (ET).
The KINETIC 2 Study did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint, The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) total score.
TETRAS is used to quantify the severity of tremors and their impact on daily living activities.
Given these results, Sage and Biogen will close the ongoing open-label safety study of SAGE-324 in ET and do not plan to conduct further clinical development of SAGE-324 in ET.
Under the terms of the collaboration and license agreement, the termination will be effective on February 17, 2025, and Sage will resume full ownership of the SAGE-324 asset.
Sage plans to continue to evaluate other potential indications, if any, for SAGE-324.
Sage and Biogen will continue to partner on Zurzuvae (zuranolone), the first and only FDA-approved oral treatment for women with postpartum depression.
Price Action: At the last check on Thursday, SAGE stock was up 1.42% at $7.12, and BIIB stock was up 1.77% at $192.42.
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