FDA Approves Bristol Myers Squibb's Zenbexus
The FDA cleared Zenbexus under NDA 221075 on Aug. 13, 2026.
Bristol Myers Squibb (BMY) won FDA approval for Zenbexus.
Bristol Myers Squibb is listed as the sponsor, and Zenbexus as the product, under application NDA221075, submission 1 (ORIG), with a status date of Aug. 13, 2026. No indication, dose, or patient population is stated.
The approval followed a quarter in which the company reported $13.0 billion of revenue, up 6%, and raised its 2026 outlook. Growth Portfolio sales were $7.6 billion, up 15%, and the company said that growth was driven primarily by Opdivo Qvantig, Reblozyl, Camzyos, Breyanzi and Opdualag. GAAP earnings were $1.62 a share and non-GAAP earnings were $2.04 a share. Bristol Myers Squibb lifted 2026 revenue guidance to a range of about $49.0 billion to $50.0 billion and increased the non-GAAP EPS range to $6.75 to $7.00. Chief executive Christopher Boerner said the Growth Portfolio “continues to deliver” and that the company was “raising our 2026 full-year outlook.”
Legacy Portfolio revenue was $5.4 billion, down 4%. The company said Eliquis demand increased, with that increase more than offset by expected continued generic impacts across the rest of that portfolio. U.S. revenue was $9.0 billion and international revenue was $4.0 billion, each up 6%.
Zenbexus’s role in that mix and timing of sales contribution are not stated.