AbbVie's Venclexta Misses Goal in Myelodysplastic Syndromes Study

AbbVie ABBV announced that the phase III VERONA study failed to meet the primary endpoint of overall survival. The study evaluated a combination therapy involving its blockbuster cancer drug Venclexta (venetoclax) in newly diagnosed patients with higher-risk myelodysplastic syndrome (MDS).

The VERONA study tested the combination of Venclexta and azacitidine against azacitidine plus placebo. Results showed a hazard ratio (HR) of 0.908, indicating that AbbVie’s combination therapy did not significantly reduce the risk of death compared to the control group. Full data from this study will be presented at a future medical meeting.

This is not the first clinical setback for Venclexta. In 2023, AbbVie reported that a late-stage study evaluating Venclexta plus dexamethasone in certain multiple myeloma patients also failed to meet its primary endpoint of progression-free survival (PFS).

Per AbbVie, these setbacks do not impact any currently approved indication for the drug.

ABBV Stock Performance

Year to date, shares of AbbVie have risen 8% compared with the industry‘s 3% growth.

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Venclexta – A Key Driver of ABBV’s Top Line

Venclexta is approved by the FDA to treat two blood disorders, namely chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). The drug is also approved for similar indications in Europe, where it is marketed under the brand name Venclyxto.

In the first three months of 2025, the drug added sales worth $665 million to AbbVie’s top line, up 12% year over year. This growth is being driven by strong demand for both CLL and AML indications.

The drug is marketed in partnership with Roche RHHBY. While both AbbVie and Roche are responsible for marketing the drug in the United States, AbbVie holds the right to commercialize the drug outside the country.

ABBV’s Growing Oncology Portfolio

Despite the VERONA setback, AbbVie has continued to diversify and expand its oncology pipeline. Initially anchored by Imbruvica and Venclexta, the company has expanded its offerings to include Epkinly, Elahere and, most recently, Emrelis, bringing the total to five oncology therapies.

ABBV also has an exciting and diverse pipeline of promising new therapies in both blood cancers and solid tumors. Notably, etentamig (formerly ABBV-383), a BCMA x CD3 bispecific antibody, is currently being evaluated in a late-stage study for relapsed/refractory multiple myeloma.

The company is also developing another c-Met targeting ADC called Temab-A (formerly ABBV-400). This drug is being evaluated in a late-stage study for metastatic colorectal cancer and mid-stage development for gastroesophageal cancer.

ABBV’s Zacks Rank

AbbVie currently carries a Zacks Rank #3 (Hold).

AbbVie Inc. Price

 

AbbVie Inc. price | AbbVie Inc. Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Immunocore IMCR and Agenus AGEN. While IMCR sports a Zacks Rank #1 (Strong Buy) at present, AGEN carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, loss estimates for Immunocore’s 2025 have improved from $1.50 to 86 cents per share. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained around 12% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.

In the past 60 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has soared nearly 88% so far this year.

Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.

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This article originally published on Zacks Investment Research (zacks.com).

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