RHHBY FDA decision: Sep 25, 2026

Gazyva (obinutuzumab) was approved by the FDA on September 25, 2026 for idiopathic nephrotic syndrome (ages 2+).

BLA 125486, supplement 043: Gazyva is approved to reduce the risk of relapse in adult and pediatric patients 2 years and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission (FDA notice of September 25, 2026).

Run-up into the decision (T-120 → T+5)

Key facts

The FDA's approval letter for BLA 125486 supplement 043 is dated September 25, 2026 (Drugs@FDA), and the FDA published its notice of the approval the same day (CDER News & Events, 1:51 PM ET). The approval carried Breakthrough Therapy, Orphan Drug and Priority Review designations. It is based on the Phase 3 INShore trial (NCT05627557) in 85 patients aged 2 and older, comparing Gazyva with mycophenolate mofetil. pdufa.bio holds no goal date for this supplement, so no early or late margin is computed. Gazyva was previously approved for certain cancers and for adults with active lupus nephritis.

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: FDA approval letter, BLA 125486 S-043, September 25, 2026

FDA record of the action: the FDA approved on September 25, 2026, per BLA 125486 SUPPL-43 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.