Neurocrine Biosciences has received U.S. Food and Drug Administration acceptance of an Investigational New Drug application to begin a Phase 2 trial of NBI-1117567, targeting cognitive impairment in Alzheimer's disease. That clearance triggers a $10mn milestone payment, worth about ¥1.59bn at the disclosed exchange rate, owed to Nxera Pharma (TSE: 4565) under its licensing deal with Neurocrine. The company said it will book the full amount as revenue in the third quarter of the fiscal year ending December 2026.
NBI-1117567 is an oral muscarinic M1-preferring (M1/M4) selective receptor agonist developed on Nxera's in-house NxWave discovery platform. It is the third muscarinic compound from the Nxera-Neurocrine collaboration to reach Phase 2 testing or later, following Direclidine (NBI-1117568), an M4 agonist now in Phase 3, and NBI-1117570, an M1/M4 dual agonist already in Phase 2.
The two companies signed a strategic research, development and licensing agreement in November 2021 covering a broader pipeline of subtype-selective muscarinic M1, M4 and M1/M4 agonists aimed at schizophrenia, dementia and other neuropsychiatric conditions. Neurocrine funds global development costs for the portfolio, with one exception: Nxera keeps development and marketing rights for the M1 agonist across all indications in Japan, while Neurocrine holds an option to co-develop and co-market it there. Nxera is entitled to further R&D funding, development, filing and sales milestones worth up to $2.6bn in total, plus sales royalties, as the wider program advances.
The cash is not new money for investors to price in. Nxera said the milestone's effect on full-year results was already folded into the consolidated earnings forecast it published on February 13, 2026. The disclosure covers only IND acceptance, a regulatory greenlight to begin testing, not any read on whether the drug will work in patients.