NORTH CHICAGO, Ill. – AbbVie (NYSE:) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of Teliso-V, a potential new treatment for a subset of lung cancer patients. This submission, announced today, targets adult patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
The application is backed by data from the Phase 2 LUMINOSITY trial, which aims to assess the safety and efficacy of Teliso-V in patients with elevated levels of the c-Met protein, a demographic that presently lacks specific anti-cancer therapies. If approved, Teliso-V would become the first-in-class therapy for these patients.
NSCLC accounts for approximately 85% of lung cancer cases, and despite treatment advancements, lung cancer remains the leading cause of cancer-related deaths globally. The c-Met protein, overexpressed in around 25% of advanced EGFR wild type, nonsquamous NSCLC patients, is often associated with poor prognosis.
Dr. Roopal Thakkar, executive vice president of research and development and chief scientific officer at AbbVie, emphasized the need for new treatment options for NSCLC patients, expressing hope that Teliso-V could improve the standard of care in oncology.
The FDA previously granted Teliso-V Breakthrough Therapy Designation in December 2021. The ongoing randomized Phase 3 confirmatory global study TeliMET NSCLC-01 is further evaluating Teliso-V as a monotherapy, with enrollment continuing across global clinical trial sites.
AbbVie’s oncology portfolio includes both approved and investigational treatments for a variety of blood and solid tumors, with over 20 investigational medicines in multiple clinical trials.
The company’s mission focuses on the discovery and delivery of innovative medicines and solutions for serious health issues, with a commitment to transforming standards of care in oncology. AbbVie also aims to ensure patient access to its cancer medicines.
The information in this article is based on a press release statement from AbbVie. Teliso-V has not yet been approved by any health regulatory authority.
In other recent news, AbbVie has reported promising results from the TEMPO-1 trial, showcasing the efficacy of their Parkinson’s treatment, tavapadon. According to BMO Capital Markets, the drug significantly reduced symptoms in patients, with further data from the TEMPO-2 study expected by year’s end. In addition, AbbVie’s drug RINVOQ has shown effectiveness in treating moderate-to-severe atopic dermatitis, particularly in the head and neck regions.
AbbVie’s ovarian cancer drug, ELAHERE, received a positive opinion from the European Medicines Agency, based on the results of the Phase 3 MIRASOL clinical trial. Furthermore, the company has declared a quarterly cash dividend of $1.55 per share, demonstrating its ongoing commitment to shareholder returns.
Analysts have shown confidence in AbbVie’s potential, with BMO Capital Markets maintaining its Outperform rating and Piper Sandler keeping its Overweight rating on the company’s stock. These recent developments underline AbbVie’s drive to provide innovative treatments in the healthcare sector.
InvestingPro Insights
AbbVie’s recent submission of a Biologics License Application for Teliso-V aligns with the company’s strong position in the biotechnology industry, as highlighted by InvestingPro data. With a substantial market capitalization of $344.4 billion, AbbVie demonstrates its significant presence in the pharmaceutical sector.
InvestingPro Tips reveal that AbbVie has raised its dividend for 12 consecutive years, reflecting a commitment to shareholder value that complements its focus on innovative treatments like Teliso-V. This consistent dividend growth, coupled with a current dividend yield of 3.23%, may appeal to investors looking for both growth potential and income.
The company’s financial health appears robust, with a revenue of $55.0 billion in the last twelve months and a gross profit margin of 69.66%. These figures suggest AbbVie has the financial resources to support its research and development efforts, crucial for bringing new treatments like Teliso-V to market.
Analysts seem optimistic about AbbVie’s prospects, with InvestingPro Tips noting that 14 analysts have revised their earnings upwards for the upcoming period. This positive sentiment aligns with the potential impact of Teliso-V and other pipeline products on the company’s future performance.
It’s worth noting that AbbVie is trading near its 52-week high, which could indicate market confidence in the company’s strategy and pipeline. However, investors should be aware that the stock is trading at a high Price / Book multiple of 50.83, suggesting a premium valuation.
For readers interested in a deeper dive into AbbVie’s financials and prospects, InvestingPro offers 12 additional tips, providing a comprehensive view of the company’s investment potential.
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