Published: 7/27/2026 8:18:16 AM

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Finwire about AcuCort AB: FDA Waives Application Fee for Acucort

FDA has granted the life science company Acucort a renewed Small Business Waiver, which means the company is exempt from the application fee of around SEK 16 million for the planned NDA application. The announcement follows the April agreement with FDA that no additional studies are required before the application. "With both the iPSP agreement and the renewed SBW in place, we are keeping our timeline. If everything goes according to plan, we will submit our NDA application during the year," says CEO Jonas Jönmark. An NDA application is normally processed in about twelve months.

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