26 June 2026 - The FDA has requested additional data related to chemistry, manufacturing, and controls and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability

Sobi today announced that the Company received a complete response letter from the US FDA for the Company’s biologics license application for NASP (nanoencapsulated sirolimus plus pegadricase) for the treatment of adult patients with uncontrolled gout.

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