FDA Decision
On 29 June 2026, the U.S. Food and Drug Administration issued a Complete Response Letter for Swedish Orphan Biovitrum AB’s (Sobi) biologics license application for NASP – a nano‑encapsulated sirolimus plus pegadricase therapy intended for uncontrolled gout. The FDA requested additional information on chemistry, manufacturing and controls and cited deficiencies at the contract manufacturing facilities, but did not raise any safety or efficacy concerns.
Market Reaction
Following the FDA communication, Sobi’s shares on the Stockholm exchange fell nearly 3%, trading down 2.5% at SEK 454.5. The decline contrasted with a modest 0.3% rise in Sweden’s benchmark OMX Stockholm 30 index, making Sobi one of the weaker performers on the market that day.
Product Profile
NASP is an investigational therapy administered as an infusion once every four weeks, designed to lower uric acid levels in adult patients whose uncontrolled gout remains poorly managed despite existing treatments. Approval of NASP would place it in direct competition with Amgen Inc.’s Krystexxa, which is currently the sole FDA‑approved therapy for uncontrolled gout.
Company Response
Sobi indicated that it will meet with the FDA to discuss the agency’s feedback, outline a path toward resubmission, and collaborate with its manufacturing partners to remediate the identified deficiencies.