Nxera reports H1 revenue of JPY 18.91 billion, returns to profit

Nxera Pharma reported stronger results for the six months ended 30 June 2026, with revenue rising to JPY 18,910 million (US$119.6 million) and the company moving from losses a year earlier to operating profit, pre-tax profit and net profit. The company said the increase was driven mainly by eight R&D milestone events in the current quarter versus five in the prior corresponding period, while lower R&D and SG&A spending reflected maturing clinical programs, a more streamlined R&D focus and targeted cost reductions. Chris Cargill, President and CEO of Nxera, said momentum from the first quarter continued through the second quarter, with steadily rising Japan revenue from PIVLAZ and QUVIVIQ. He also highlighted regulatory progress for vamorolone in South Korea, where the MFDS (South Korea drug regulator) granted Orphan Drug Designation and GIFT designation, a fast-track review pathway, to support quicker patient access ahead of a planned Marketing Authorization Application (drug approval filing) in 2026. Operationally, Nxera said it signed a licensing agreement with Santhera Pharmaceuticals for vamorolone, marketed internationally as AGAMREE, across Japan, South Korea, Australia and New Zealand. Daridorexant also advanced in South Korea after positive Phase 3 topline data in adults and elderly patients with insomnia disorder, and an MAA was submitted to the MFDS on 4 March 2026. In Taiwan, commercial partner Holling Bio-Pharma Corp. received approval from the TFDA (Taiwan drug regulator) for QUVIVIQ 25 mg and 50 mg in adult insomnia, with launch expected during 2026. Partnered programs added materially to revenue. Nxera received US$22.5 million from Neurocrine Biosciences after first-patient dosing in a Phase 2 schizophrenia study of NBI-1117570, while additional milestones came from Centessa Pharmaceuticals-linked orexin receptor 2 agonist programs, Lilly under a diabetes and metabolic diseases collaboration, and AbbVie under a neurological diseases discovery alliance. Nxera also signed a license agreement with a newly established company, NewCo, around a GPCR-targeted program (drug program aimed at cell-surface receptors), taking an equity stake and securing rights to up to US$275 million in milestones plus tiered royalties, while retaining commercialization rights in Japan and certain Asia-Pacific territories. The company said Lilly's completed acquisition of Centessa Pharmaceuticals on 24 June 2026 further underlined the value of Nxera-developed assets because Nxera retains the right to future milestone and royalty payments from the jointly created orexin receptor agonist pipeline. Backed by what it described as continuing momentum and a robust financial position, Nxera said it remains focused on sustained growth and value creation in the second half of 2026.

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