INDIANAPOLIS - Eli Lilly and Company (NYSE: NYSE:LLY) has unveiled new data indicating that mirikizumab, its investigational treatment for Crohn's disease, achieved a higher rate of histologic response compared to ustekinumab after 52 weeks of treatment. The findings from the VIVID-1 Phase 3 study were presented at the United European Gastroenterology (UEG) Week in Vienna, Austria, which took place from October 12-15.
The study is the first to report both histologic and combined histologic-endoscopic outcomes in Crohn's disease, following a systematic assessment of five bowel segments. Histologic inflammation, which occurs at the cellular level, can persist in patients despite endoscopic mucosal healing, highlighting the need for treatments that offer deeper intestinal healing.
Results showed that 58.2% of patients treated with mirikizumab achieved histologic response at Week 52, compared to 48.8% for ustekinumab. In a subgroup of patients with prior biologic failure, mirikizumab also demonstrated a greater histologic response, with 56.5% versus 41.3% for ustekinumab.
Mirikizumab's safety profile in this study was consistent with that observed in patients with ulcerative colitis (UC), and the frequency of serious adverse events was higher in the placebo group. Common adverse events included COVID-19, anemia, arthralgia, headache, upper respiratory tract infection, nasopharyngitis, and injection site reactions.
Dr. Fernando Magro, head of clinical pharmacology at University Hospital São João, emphasized the importance of evaluating the depth of intestinal healing beyond traditional clinical remission and endoscopy.
Eli Lilly has submitted marketing authorization applications for mirikizumab in Crohn's disease globally, with additional regulatory submissions planned. The company continues to investigate the long-term efficacy and safety of mirikizumab in both pediatric and adult patients with inflammatory bowel disease.
Mirikizumab, marketed as Omvoh™, is already approved for the treatment of moderately to severely active UC in adults. The company's commitment to advancing treatment options is evident in its ongoing trials for UC and Crohn's disease.
This report is based on a press release statement by Eli Lilly and Company.
In other recent news, Eli Lilly has been the subject of various analyst adjustments and significant developments. Leerink Partners maintained its Outperform rating on Eli Lilly, adjusting its financial model to anticipate the company's third-quarter results. The firm increased its third-quarter revenue estimate from $12.0 billion to $12.2 billion and raised its prediction for pre-IPR&D operating income for the third quarter by 4%, from $4.7 billion to $4.9 billion.
Eli Lilly is also involved in a legal dispute with the U.S. Food and Drug Administration (FDA) and the Outsourcing Facilities Association over its weight loss and diabetes medication, tirzepatide. The association alleges that the drug is still in short supply, contradicting the FDA's recent update.
Furthermore, Texas Attorney General Ken Paxton has initiated a lawsuit against three major insulin manufacturers, including Eli Lilly, alleging that these entities have conspired to artificially inflate the price of insulin.
Meanwhile, Truist Securities raised the company's share price target and maintained a Buy rating due to ongoing investments in manufacturing, particularly for the drug Zepbound. Truist Securities forecasts Eli Lilly's revenues to increase significantly over the next few years.
Lastly, U.S. Senator Elizabeth Warren and competitor Eli Lilly raised concerns about Novo Holdings' acquisition of Catalent (NYSE:CTLT) for $16.5 billion, worrying that it could give Novo Nordisk (NYSE:NVO) an unfair competitive edge in the market for weight loss and obesity medications. These are recent developments that investors should keep an eye on.
InvestingPro Insights
Eli Lilly's promising results for mirikizumab in Crohn's disease treatment align with the company's strong financial performance and market position. According to InvestingPro data, Eli Lilly boasts a substantial market capitalization of $839.25 billion, reflecting investor confidence in its growth potential and innovative pipeline.
The company's revenue growth is particularly noteworthy, with a 31.87% increase over the last twelve months as of Q2 2024, and an even more impressive 35.98% quarterly growth. This robust revenue expansion underscores Eli Lilly's success in bringing new treatments to market and expanding its existing product lines.
InvestingPro Tips highlight Eli Lilly's financial strength and market leadership. The company is recognized as a "Prominent player in the Pharmaceuticals industry," which is evident from its continued innovation in treatments like mirikizumab. Additionally, Eli Lilly "Has maintained dividend payments for 54 consecutive years," demonstrating its commitment to shareholder returns alongside its focus on research and development.
The company's profitability is also worth noting, with InvestingPro data showing a gross profit margin of 80.75% for the last twelve months as of Q2 2024. This high margin suggests that Eli Lilly's products, including potential blockbusters like mirikizumab, command strong pricing power in the market.
While Eli Lilly's valuation metrics appear high, with a P/E ratio of 114.01, this could be justified by the company's strong growth prospects and the potential of its drug pipeline. Investors seem willing to pay a premium for Eli Lilly's future earnings potential, as evidenced by the stock trading near its 52-week high.
For readers interested in a deeper dive into Eli Lilly's financial health and market position, InvestingPro offers 18 additional tips, providing a comprehensive view of the company's investment profile.
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