Enspryng (satralizumab) was approved by the FDA for adults with thyroid eye disease (TED); the approval was announced on October 15, 2026.
Genentech says Enspryng is the first and only at-home subcutaneous treatment for thyroid eye disease, given every four weeks during maintenance. It is the second indication for Enspryng, an IL-6 receptor inhibitor, after neuromyelitis optica spectrum disorder in 2020.
Genentech announced on October 15, 2026 that the FDA had approved Enspryng for adults with thyroid eye disease (Genentech's announcement). The goal date was October 15, 2026, under priority review (Genentech, June 29, 2026). The release does not state the day the FDA acted, and the FDA's letter for BLA 761149 had not been posted on Drugs@FDA when this page was published, so pdufa.bio holds no FDA record of the action day yet and computes no early or late margin. The approval rests on the Phase III SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828) studies, identically designed and placebo-controlled, 258 patients in 19 countries. Per Genentech, SatraGO-1 did not meet its pre-specified primary endpoint at week 24; SatraGO-2 showed a proptosis response of 52.9% with Enspryng versus 23.4% on placebo and diplopia reduction of 60.7% versus 25.8% in patients with active TED, with consistent results in the overall population. Genentech reported no new safety signals. A further Enspryng decision is pending: MOGAD, with a goal date of January 10, 2027 (Enspryng MOGAD PDUFA date).
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Genentech press release, October 15, 2026
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Yes. The sponsor announced on October 15, 2026 that the FDA had approved the application for Enspryng (satralizumab-mwge); the announcement does not state the day the FDA acted. The primary source is linked on this page.
Enspryng (satralizumab-mwge) is a Roche Holding AG (Genentech) (RHHBY) program. The company announced the FDA decision on October 15, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), RHHBY moved +7.8%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
Yes. Genentech announced on October 15, 2026 that the FDA approved Enspryng (satralizumab-mwge) for adults with thyroid eye disease (TED), its goal date. Genentech describes it as the first and only at-home subcutaneous treatment for TED. pdufa.bio holds no FDA record of the action day yet; the FDA's letter had not been posted on Drugs@FDA when this page was published.
The Phase III SatraGO-1 and SatraGO-2 studies, 258 patients in total. Per Genentech, SatraGO-1 did not meet its primary endpoint at week 24, while SatraGO-2 showed a proptosis response of 52.9% with Enspryng versus 23.4% on placebo and diplopia reduction of 60.7% versus 25.8% in patients with active TED.
Yes. Genentech says the FDA is expected to decide on Enspryng for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease) by January 10, 2027, under priority review.