Tokyo, Japan and Cambridge, UK, 13 February 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) provides an update on operational activities and reports its consolidated results for the fourth quarter and 12 months ended 31 December 2025. The full report can be viewed here.
Christopher Cargill, President and CEO of Nxera Pharma, commented: “2025 was a year of disciplined execution and strategic progress for Nxera, as we continued to build a more focused, resilient and scalable biopharmaceutical business with a growing commercial footprint in Japan and a maturing pipeline.
“In doing so, we further strengthened our commercial foundations in Japan and the broader APAC region, with PIVLAZ® for the prevention of cerebral vasospasm after aneurysmal subarachnoid haemorrhage firmly established as the standard of care in Japan. We made continued progress with QUVIVIQ™ for insomnia, including manufacturing enhancements to support increasing demand and improve long-term profitability. We also expanded our late- and commercial-stage portfolio through targeted business development, most notably with the licensing of vamorolone for Duchenne Muscular Dystrophy from Swiss specialty pharmaceutical company Santhera as well as new regional partnerships for daridorexant.
“Across our pipeline, 2025 delivered important clinical and strategic milestones. Our partners continued to advance multiple programs into later-stage development, generating approximately US$35 million in milestone payments. Importantly, Neurocrine’s initiation of Phase 3 studies with NBI-‘568 marked a significant step forward for our most advanced neuroscience asset from a portfolio of muscarinic agonists discovered by Nxera and licensed to Neurocrine.
“At the same time, we took decisive steps to sharpen our focus and enhance our path to profitability, implementing a targeted restructuring and prioritizing programs and platforms with the greatest long-term potential for value creation. These were hard decisions and were not taken lightly but are crucial to positioning Nxera for future success. I am very grateful for the important contributions made by all our employees over the last 12 months towards this goal. These steps included regaining full rights to our GPR52 agonist program, following which Nxera plans to explore all strategic opportunities for this promising clinical asset. In addition, we launched a new proprietary pipeline in obesity and metabolic disease, leveraging the full power of our NxWave™ platform to address important areas of emerging patient need in this highly attractive commercial space.
“As we enter 2026, Nxera is well positioned with multiple upcoming clinical and regulatory catalysts and a clear strategic focus. I am extremely proud of what our teams have delivered during the year, and I am confident in our ability to build on this momentum as we continue to advance innovative medicines for patients in Japan and around the world.”
Operational Highlights for Q4 2025
- Growth in PIVLAZ® (clazosentan sodium) 150mg sales continued in Japan
Clear standard of care in Japan with neurosurgeons for prevention of cerebral vasospasm in patients with aneurysmal subarachnoid haemorrhage (aSAH)
Market share increased from 69% in 2024 to 74% in 2025
Q4 2025 net sales of JPY 4,545 million (US$30.4 million), FY 2025 net sales of JPY 13,511 million (US$90.3 million), representing 6.8% growth vs FY 2024.
Approval obtained for a partial change to the QUVIVIQ™ manufacturing and marketing authorization, including approval for an additional manufacturing site in Asia for QUVIVIQ™ 25 and 50 mg, to ensure stable supply for increasing demand in Japan and the broader APAC region
Expected to improve profitability through manufacturing cost reductions
QUVIVIQ™ was launched in December 2024 under a commercial agreement with Shionogi
FY 2025 net sales of JPY 4,327 million (US$28.9 million), representing 223.9% growth vs FY 2024
- Nxera’s partner Cancer Research UK presented data from the successfully completed Phase 1 clinical trial of HTL’732 at the European Society for Medical Oncology Congress (ESMO) 2025
HTL’732 was well-tolerated, confirmed target engagement and demonstrated encouraging early efficacy in two distinct tumor types when administered in combination with the immune checkpoint inhibitor atezolizumab
The Phase 1 trial met the key objectives and identified a …