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INDIANAPOLIS - The U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Eli Lilly and Company’s (NYSE:LLY) olomorasib, in combination with Keytruda, for certain first-line lung cancer treatments, the company announced Thursday. Eli Lilly, with a market capitalization of $660 billion and an impressive gross profit margin of 82.64%, continues to strengthen its position as a prominent player in the pharmaceutical industry.
The designation applies to olomorasib when used with pembrolizumab for treating patients with unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation and PD-L1 expression of 50% or higher. The company’s robust research and development efforts are supported by strong revenue growth of 36.83% in the last twelve months, according to InvestingPro data.
Olomorasib is described as a selective second-generation inhibitor of KRAS G12C with preliminary evidence of central nervous system activity. The Breakthrough Therapy designation aims to expedite development and review of drugs showing potential substantial improvement over existing approved therapies.
"The Breakthrough Therapy designation recognizes the potential for olomorasib to be a meaningful treatment advance," said David Hyman, Lilly’s chief medical officer, in the press release.
The FDA’s decision was based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial. Lilly will present updated efficacy and safety data at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer in Barcelona, Spain, from September 6-9.
According to the company statement, KRAS is the most common oncogene across tumor types, with KRAS G12C mutations occurring in 13% of NSCLC patients and 1-3% of patients with other solid tumors.
The drug is currently being studied in multiple clinical trials for KRAS G12C-mutated cancers, both as a monotherapy and in various combinations with immunotherapy and chemotherapy.
In other recent news, Eli Lilly announced positive results from its ATTAIN-2 clinical trial for the weight loss drug orforglipron, showing peak placebo-adjusted weight loss of 8.3% in obese patients with type 2 diabetes. This development has led BMO Capital to reiterate an Outperform rating with a price target of $840. UBS also maintained its Buy rating and set a price target of $895 following these favorable Phase 3 trial results. Additionally, TD Cowen reiterated a Buy rating with a price target of $960, noting significant weight loss and A1C reduction achieved at the highest dose over 72 weeks. William Blair highlighted the drug’s strong performance in patients with both obesity and type 2 diabetes, exceeding investor expectations. In another development, Eli Lilly reported that its breast cancer drug Verzenio showed a statistically significant improvement in overall survival when combined with endocrine therapy in high-risk patients. The Phase 3 monarchE trial results demonstrated sustained benefits in both invasive disease-free survival and distant relapse-free survival. These recent developments have caught the attention of several investment firms, reflecting optimism about Eli Lilly’s ongoing research and development efforts.
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