satralizumab news

All news on satralizumab (also known as Enspryng): plants, production capacities, investments and involved companies.

10 September 2026

Roche's Enspryng granted FDA Priority Review for MOGAD

FDA accepted the application for satralizumab for adult and adolescent MOGAD and granted Priority Review with a decision due 10 Jan 2027; EMA validated the MAA, EC decision expected Q3 2027.
10 September 2026

Roche: FDA grants Priority Review for Enspryng in MOGAD

FDA to decide by 10 Jan 2027 on satralizumab for MOGAD after Phase III METEOROID showed 68% relapse risk reduction; EMA validation pending EC decision in Q3 2027.
9 September 2026

Genentech: FDA grants Priority Review for Enspryng in MOGAD

Priority Review follows Phase III METEOROID showing 68% relapse risk reduction; FDA decision expected Jan 10, 2027; EMA validated the MOGAD filing with EC decision due Q3 2027.
31 July 2026

Chugai files for Enspryng indication to prevent relapses in MOGAD in Japan

Regulatory submission seeks approval of satralizumab to prevent relapse in MOG antibody‑associated disease after Phase III showed a 68% risk reduction.
30 June 2026

Roche’s Enspryng wins FDA Priority Review for at‑home subcutaneous TED treatment

FDA accepted an sBLA and granted Priority Review for the first at‑home subcutaneous option for thyroid eye disease; decision expected 15 Oct 2026.

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