Morgan Stanley adds Amazon.com as Top Pick
INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a prominent pharmaceutical player with a market capitalization of $653 billion and impressive revenue growth of 37% in the last twelve months, announced Monday that its non-covalent BTK inhibitor Jaypirca (pirtobrutinib) demonstrated a statistically significant improvement in progression-free survival compared to standard chemoimmunotherapy in previously untreated chronic lymphocytic leukemia patients. According to InvestingPro data, the company’s strong financial health and consistent dividend payments for 55 consecutive years underscore its market leadership position.
The Phase 3 BRUIN CLL-313 trial evaluated pirtobrutinib against bendamustine plus rituximab in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions. The study met its primary endpoint with what the company described as "one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study." With 14 analysts recently revising their earnings estimates upward and a consensus price target suggesting potential upside, this development could further strengthen Eli Lilly’s market position. Discover more detailed analysis and 15+ additional ProTips with InvestingPro.
Overall survival data, a key secondary endpoint, was not yet mature but is trending favorably for pirtobrutinib, with final analysis expected in 2026. The drug’s safety profile remained consistent with previous trials.
This marks the third positive Phase 3 study for pirtobrutinib in CLL. Results from this trial and the recently announced positive BRUIN CLL-314 study will support regulatory submissions for expanding pirtobrutinib’s approved indications to earlier treatment lines, with global filings expected to begin later this year.
Pirtobrutinib is currently approved under accelerated approval for relapsed or refractory mantle cell lymphoma after at least two prior therapies including a BTK inhibitor, and for CLL/SLL after at least two prior therapies including both a BTK inhibitor and a BCL-2 inhibitor.
Detailed results from the BRUIN CLL-313 trial will be presented at an upcoming medical congress and submitted for publication in a peer-reviewed journal, according to a press release statement from the company. With the stock currently trading near InvestingPro’s Fair Value and maintaining strong profitability metrics, including an impressive 83% gross profit margin, investors seeking comprehensive analysis can access the full InvestingPro Research Report, which is part of the platform’s coverage of 1,400+ top US stocks.
In other recent news, Eli Lilly and Company announced that its breast cancer drug Verzenio showed a statistically significant improvement in overall survival for high-risk breast cancer patients. This finding came from the Phase 3 monarchE trial, which demonstrated sustained benefits in invasive disease-free survival and distant relapse-free survival. Additionally, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to Eli Lilly’s lung cancer drug, olomorasib, in combination with Keytruda, for certain first-line lung cancer treatments. This designation applies to patients with unresectable advanced or metastatic non-small cell lung cancer with specific genetic markers.
In other developments, Eli Lilly’s weight loss drug orforglipron showed promising results in the ATTAIN-2 clinical trial, with a peak placebo-adjusted weight loss of 8.3% in obese patients with type 2 diabetes. This success has led to BMO Capital reiterating its Outperform rating on the company’s stock, setting up orforglipron for an FDA filing by the end of the year. UBS also maintained its Buy rating on Eli Lilly following the positive Phase 3 trial results for orforglipron. These recent developments highlight Eli Lilly’s ongoing advancements in cancer and obesity treatments.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.