Roche RHHBY announced that the FDA has granted Priority Review to the company’s supplemental biologics license application (sBLA) seeking label expansion of Gazyva/Gazyvaro (obinutuzumab).
The sBLA is seeking approval of the drug for the treatment of primary membranous nephropathy (pMN).
The FDA’s priority review is based on the positive phase III MAJESTY results, which showed superiority of Gazyva/Gazyvaro over an immunosuppressive therapy, tacrolimus, in adults with pMN.
Please note that Gazyva/Gazyvaro has already received Breakthrough Therapy Designation (BTD) from the FDA for pMN, with an approval decision anticipated by November 2026.
Year to date, shares of RHHBY have lost 2.7% against the industry’s growth of 10.6%.
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More on RHHBY’s Gazyva/Gazyvaro
This latest development marks the second recent Priority Review granted to Gazyva/Gazyvaro by the FDA, following the acceptance of its application for idiopathic nephrotic syndrome in May 2026.
A potential approval would make Gazyva/Gazyvaro the first FDA-approved therapy for pMN, expanding its nephrology franchise beyond its approved use in lupus nephritis and pending regulatory filings in lupus and idiopathic nephrotic syndrome.
Gazyva/Gazyvaro is already approved in the United States and the European Union for adults with lupus nephritis and is also approved in more than 100 countries for the treatment of multiple hematological malignancies.
Sales from the drug totaled $247 million in the first quarter of 2026, up 10% year over year.
pMN is a chronic autoimmune kidney disease that can cause progressive and irreversible kidney damage, potentially leading to kidney failure.
MAJESTY is the fourth positive phase III study of Gazyva/Gazyvaro in immune-mediated diseases, following the REGENCY study in lupus nephritis, ALLEGORY in systemic lupus erythematosus (SLE) and INShore in idiopathic nephrotic syndrome.
The FDA has also granted Priority Review and BTD to Gazyva/Gazyvaro for idiopathic nephrotic syndrome.
The drug is also being investigated in the phase II POSTERITY study for children and adolescents with lupus nephritis.
Beyond Gazyva/Gazyvaro, Roche continues to strengthen its immunology pipeline with a focus on developing innovative therapies for immune-mediated kidney diseases.
This includes another drug in its portfolio, Lunsumio (mosunetuzumab), a first-in-class CD20xCD3 T-cell-engaging bispecific antibody which is currently being evaluated in SLE.
The company's expanding immunology portfolio provides additional long-term growth opportunities beyond its marketed products.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.
The FDA recently accepted and granted Priority Review to RHHBY’s new drug application for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), for the adjuvant treatment of adults with ER-positive, HER2-negative stage I–III breast cancer. A regulatory decision is expected by Nov. 30, 2026.
Roche further strengthened its pipeline through an exclusive recent licensing and collaboration agreement with Nurix Therapeutics NRIX to co-develop and co-commercialize bexobrutideg (NX-5948) for hematology, immunology and neurology indications. The deal broadens Roche's presence in hematological cancers while providing additional long-term growth opportunities in autoimmune and neurological diseases.
Under the terms of the agreement, Nurix will receive an upfront payment of $700 million and is eligible for up to $2.3 billion in development, regulatory and commercial milestone payments. Roche will fund 60% of development costs, with Nurix responsible for the remaining 40%. In the United States, the companies will jointly commercialize bexobrutideg and share profits and losses equally. Roche will hold exclusive commercialization rights outside the United States, with Nurix receiving tiered royalties ranging from the low- to high-teens.
While Roche is making efforts to further diversify its broad portfolio, the company remains a late entrant into the highly competitive obesity market, which is currently dominated by other large-cap pharma players, such as Eli Lilly LLY and Novo Nordisk NVO.
Roche’s obesity assets include enicepatide (CT-388) and petrelintide. Roche is rapidly advancing its obesity pipeline, with both enicepatide and petrelintide progressing into phase III studies.
Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1/GIP receptor agonists, Mounjaro and Zepbound.
LLY’s arch rival Novo Nordisk also commands a strong position with its semaglutide-based GLP-1 therapies, Ozempic and Wegovy, which are used to treat type 2 diabetes and obesity.
With LLY and NVO deriving a significant portion of their revenues from cardiometabolic medicines, Roche faces an uphill battle to gain meaningful market share despite its expanding late-stage pipeline.
RHHBY’s Zacks Rank
Roche currently has a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).