Page updated ·next FDA decision on the calendar·Data as of Nov 14, 2026 7:42 PM ET
✓ APPROVED
On November 13, 2026, the FDA announced its approval of Gazyva (obinutuzumab) - primary membranous nephropathy (MAJESTY) for primary membranous nephropathy.
Verified against: FDA action day not yet posted on Drugs@FDA · Announcement November 13, 2026 (FDA notice) · Goal month November 2026, no day stated (Genentech press release).
The FDA approved Gazyva (obinutuzumab) for adults with primary membranous nephropathy at risk of disease progression, to induce remission of proteinuria, per its notice of November 13, 2026: the first drug approved specifically for the disease.
Run-up into the decision (T-120 → T+0)
Daily close, T-120 (5/26/26) through T+0. Run-up high $61.39 on 11/9/26, low $49 on 6/3/26 (T-120 to T-1). FDA decision 11/13/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-11-13
OutcomeApproved
Drug / candidateGazyva (obinutuzumab)
IndicationPrimary membranous nephropathy at risk of disease progression, to induce remission of proteinuria (adults)
CompanyRoche Holding AG (Genentech)
Market-cap tierLarge
120-day run-up (T-120→T-1)+14.9%
Cohort decision-day move (history)1.0% median (n=898)
Genentech guided the decision to November 2026 (Priority Review, July 14, 2026), so no early or late margin is stated. Per the FDA: in MAJESTY (142 adults, Gazyva versus tacrolimus), complete remission at week 104 was 36% versus 6%. Gazyva carries a boxed warning for hepatitis B reactivation and PML.
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.
Yes. The sponsor announced on November 13, 2026 that the FDA had approved the application for Gazyva (obinutuzumab); the announcement does not state the day the FDA acted. The primary source is linked on this page.
Which company is behind Gazyva (obinutuzumab)?
Gazyva (obinutuzumab) is a Roche Holding AG (Genentech) (RHHBY) program. The company announced the FDA decision on November 13, 2026; the company's own announcement is linked on this page.
How did RHHBY stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), RHHBY moved +14.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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