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NORTH CHICAGO - AbbVie (NYSE: ABBV), a prominent player in the biotechnology industry with annual revenue of $57.37 billion, announced today that its Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet its primary endpoint of overall survival. According to InvestingPro, the company maintains strong financials with an EBITDA of $27.37 billion.
The trial showed a hazard ratio of 0.908 with a stratified log-rank p-value of 0.3772, indicating the treatment did not demonstrate statistically significant improvement in patient survival compared to azacitidine with placebo. No new safety concerns were identified during the study. Despite this setback, 10 analysts have recently revised their earnings estimates upward for the upcoming period, as reported by InvestingPro.
AbbVie indicated that detailed results from the VERONA trial will be presented at a future medical congress or in a scientific publication. Patients who received the venetoclax-azacitidine combination through participation in MDS clinical trials will be informed by their physicians about the results.
The company emphasized that these findings do not affect any current approved indications for venetoclax, which is marketed as VENCLEXTA/VENCLYXTO. The drug is currently approved for use in chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia in various combinations. AbbVie’s strong market position is reflected in its consistent dividend payments, which it has maintained for 13 consecutive years, with a current yield of 3.43%. Get more detailed insights about AbbVie’s financial health and growth prospects through InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.
Venetoclax is a targeted therapy that selectively binds to and inhibits the B-cell lymphoma-2 (BCL-2) protein, which in some blood cancers prevents cancer cells from undergoing their natural death process. The drug is being developed by AbbVie and Roche, and is jointly commercialized by AbbVie and Genentech in the U.S.
The VERONA trial was a randomized, controlled study that enrolled patients with newly diagnosed higher-risk MDS, according to information provided in the company’s press release statement.
In other recent news, AbbVie received FDA approval for MAVYRET, now the first oral treatment for acute hepatitis C, expanding its use to both adults and children. This approval follows a Phase 3 study indicating a 96% cure rate, aiming to address the significant healthcare costs associated with untreated HCV. Additionally, the FDA granted accelerated approval for AbbVie’s EMRELIS, a treatment for advanced non-small cell lung cancer, marking a crucial option for patients with limited alternatives. The approval was based on promising clinical trial results, although further verification is required. In another development, AbbVie has entered a strategic collaboration with ADARx Pharmaceuticals to develop siRNA therapies, combining their expertise to advance treatments in several therapeutic areas. On the financial front, Berenberg adjusted its price target for AbbVie to $170 from $195, maintaining a Hold rating, citing the importance of Skyrizi in driving growth. Meanwhile, Citi downgraded AbbVie from Buy to Neutral, trimming the price target to $205, due to concerns about the company’s pipeline and policy risks. Despite these adjustments, AbbVie’s commitment to innovation and strategic partnerships continues to shape its outlook in the industry.
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