• Nippon Shinyaku published an FY2025 earnings call transcript attended by President Toru Nakai, Director Takanori Edamitsu, Director Kazuyuki Iwata, Director Keiichi Kuwano.
• Forecast revenue JPY 200 billion for FY2026, up 17.1% YoY; operating profit seen at JPY 38 billion, up 7.1% YoY.
• CAP-1002 partner Capricor sued to terminate the US marketing agreement; management expects FDA decision by Aug. 22, targets US launch before year-end.
• Management said CAP-1002 is not economically viable under the current contract due to US price-reporting mechanics; proposed a PLD model amendment.
• RGX-121 FDA clinical hold lifted; REGENXBIO appealed a February Complete Response Letter; timing remains under discussion with the FDA.

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