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NORTH CHICAGO - AbbVie (NYSE:ABBV), a prominent player in the biotechnology industry with a market capitalization of $333 billion and robust gross profit margins of 71%, submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for a fixed-duration, all-oral combination regimen of VENCLEXTA (venetoclax) and acalabrutinib for previously untreated chronic lymphocytic leukemia (CLL) patients. According to InvestingPro analysis, the company maintains a strong financial health score, positioning it well for continued innovation in the pharmaceutical space.
The application is supported by data from the Phase 3 AMPLIFY trial, which demonstrated that the combination therapy reduced the risk of disease progression or death by 35% compared to standard chemoimmunotherapy. The trial evaluated the treatment in previously untreated CLL patients without del(17p) or TP53 mutation. With annual revenue of $57.37 billion and consistent dividend payments for 13 consecutive years, AbbVie continues to demonstrate strong market presence in developing breakthrough therapies.
If approved, this would offer CLL patients a fixed-duration treatment option that could allow for treatment-free periods, a significant consideration in disease management.
"This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer," said Svetlana Kobina, vice president of global medical affairs, oncology at AbbVie, in the press release.
The safety profile of the combination was consistent with known profiles of each individual therapy. The most common adverse events included neutropenia, hemorrhage, and COVID-19, with neutropenia being the most frequent Grade 3 or higher adverse event, occurring in 26.8% of patients.
VENCLEXTA, jointly commercialized by AbbVie and Genentech in the U.S., works by selectively binding and inhibiting the B-cell lymphoma-2 protein, helping to restore the natural cell death process in cancer cells. The drug is currently approved in more than 80 countries for various blood cancer indications.
AbbVie stated in its announcement that the combination therapy has the potential to be practice-changing in frontline CLL care if approved. For investors seeking deeper insights into AbbVie’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, available as part of the platform’s coverage of 1,400+ top US stocks. The report includes detailed financial metrics, growth projections, and expert analysis to help investors make informed decisions.
In other recent news, AbbVie has entered into an exclusive licensing agreement with IGI Therapeutics for the investigational cancer therapy ISB 2001, a trispecific antibody currently in Phase 1 clinical trials for relapsed/refractory multiple myeloma. As part of the deal, AbbVie will pay $700 million upfront and could potentially pay up to $1.225 billion in milestone payments, along with tiered double-digit royalties on net sales. This agreement grants AbbVie the rights to develop, manufacture, and commercialize ISB 2001 across North America, Europe, Japan, and Greater China.
Furthermore, AbbVie announced an update to its 2025 earnings guidance to reflect an $823 million expense related to acquired in-process research and development and milestones, which is expected to negatively impact earnings per share by $0.42. In analyst ratings, JPMorgan has maintained its Overweight rating on AbbVie with a price target of $200, citing strong performance from the company’s Skyrizi and Rinvoq products. The firm projects AbbVie’s quarterly sales to reach $15 billion with earnings per share of $2.87. These developments underscore significant strategic and financial activities for AbbVie.
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