BofA update shows where active managers are putting money
INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a pharmaceutical giant with a market capitalization of $725 billion and an impressive 81.7% gross profit margin, announced Tuesday that its non-covalent BTK inhibitor Jaypirca (pirtobrutinib) met its primary endpoint in a Phase 3 trial comparing it to Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). According to InvestingPro analysis, Eli Lilly maintains a "GREAT" financial health score, positioning it strongly for continued R&D investment.
The BRUIN CLL-314 trial, which enrolled both treatment-naïve patients and those previously treated but BTK inhibitor-naïve, demonstrated non-inferiority on overall response rate with a nominal p-value for superiority (p
According to the company, this marks the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve CLL patients. This subgroup, comprising 225 patients, had the longest follow-up and showed a particularly pronounced progression-free survival effect favoring pirtobrutinib.
The safety profile observed in the trial was consistent with previous studies of the drug. Lilly plans to present detailed results at a medical conference later in 2025.
Jacob Van Naarden, executive vice president and president of Lilly Oncology, stated this is the second positive Phase 3 study in the pirtobrutinib development program, following the BRUIN CLL-321 trial in patients previously treated with covalent BTK inhibitors.
The company expects results from another Phase 3 study, BRUIN CLL-313, later this year. Combined with the BRUIN CLL-314 results, these will form the basis for regulatory submissions globally.
Jaypirca is currently approved under accelerated approval for certain relapsed or refractory mantle cell lymphoma patients and for CLL/SLL patients who have received at least two prior lines of therapy.
The information in this article is based on a company press release statement. Eli Lilly continues to demonstrate strong financial performance with 36.38% revenue growth in the last twelve months, reinforcing its position as a prominent player in the pharmaceutical industry.
In other recent news, Eli Lilly’s Alzheimer’s drug Kisunla received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending it for early symptomatic Alzheimer’s disease. The European Commission is expected to make a final decision on the drug in the coming months. Additionally, the U.S. Food and Drug Administration approved a new dosing schedule for Kisunla, which significantly reduces the incidence of certain imaging abnormalities while maintaining effective amyloid plaque removal. Eli Lilly has also completed its tender offer for Verve Therapeutics, with 55.7% of Verve’s shares tendered, offering shareholders $10.50 per share in cash and a contingent value right. On the analyst front, BMO Capital reiterated an Outperform rating on Eli Lilly, maintaining a $900 price target and noting potential early interim analysis for the company’s Alzheimer’s trial. Guggenheim raised its price target for Eli Lilly to $942, projecting second-quarter Mounjaro sales of $4.49 billion, slightly below some consensus estimates. These developments reflect a period of significant activity for Eli Lilly, involving regulatory advancements, strategic acquisitions, and positive analyst attention.
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