Neurocrine Biosciences has begun a Phase 2, double‑blind, placebo‑controlled study of NBI‑1117570, an orally administered dual muscarinic M1/M4 receptor agonist, in adults with schizophrenia. The trial, registered as NCT07288333, will enroll roughly 120 patients and will evaluate efficacy through changes in the Positive and Negative Syndrome Scale (PANSS) total score, with safety and tolerability assessed via treatment‑emergent adverse events.
The company will receive a $22.5 million milestone payment from its partner Nxera Pharma, which will be recognized as revenue in the first quarter of fiscal 2026. The payment reflects progress in the collaboration and provides a tangible financial benefit that helps offset the earnings miss reported in the most recent quarter.
This study marks the second NxWave‑designed compound to reach Phase 2 in Neurocrine’s muscarinic agonist portfolio, following the earlier NBI‑1117568 program. The trial expands the company’s schizophrenia pipeline and validates the NxWave discovery platform, which has produced multiple candidates targeting the same receptor family.
Schizophrenia affects roughly 24 million people worldwide, and the U.S. market alone incurs more than $150 billion in annual costs. The unmet need for treatments that address both cognition and psychosis underpins the strategic importance of NBI‑1117570, which targets M1 for cognition and M4 for psychosis.
In Q4 2025, Neurocrine reported revenue of $805.5 million, beating estimates, but earnings per share of $1.88 fell short of the $2.36 consensus. The milestone payment will help mitigate the earnings miss and support the company’s financial position moving forward.
The study began in March 2026 and is expected to complete in August 2027. The data generated will inform future development decisions and could accelerate the company’s path to a new schizophrenia therapy.
The initiation of the Phase 2 trial signals progress toward a potential new treatment for schizophrenia and reinforces Neurocrine’s focus on muscarinic receptor targets. The milestone payment and pipeline expansion position the company to capitalize on the large schizophrenia market.
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