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Eli Lilly's (LLY) Mirikizumab Meets Crohn's Disease Study Goals
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Eli Lilly (LLY - Free Report) announced encouraging data from the phase III VIVID-1 study, which evaluated its IL-23p19 antibody mirikizumab for adult patients with moderate-to-severe Crohn’s disease (“CD”).
The VIVID-1 study achieved its co-primary and all major secondary endpoints. Mirikizumab demonstrated clinical remission and endoscopic response in CD patients following a 52-week treatment period, compared to placebo.
A form of inflammatory bowel disease, CD can cause inflammation in the digestive tract, leading to diarrhea, abdominal pain, fatigue and weight loss.
Per Lilly, 51.4% of study participants who received mirikizumab achieved clinical remission, compared with 19.6% for those on placebo. Treatment with the drug also demonstrated non-inferiority compared to J&J’s (JNJ - Free Report) blockbuster drug Stelara (ustekinumab) in CD indication.
Treatment with the Lilly drug did not achieve superiority in the endoscopic response endpoint compared with J&J’s Stelara. However, management did mention that the mirikizumab results were ‘numerically higher’ compared with the J&J drug.
Based on the above data, Lilly will submit a regulatory filing with the FDA and other regulatory agencies worldwide next year, seeking approval for mirikizumab in CD indication.
Shares of Eli Lilly have surged 66.9% year to date compared with the industry’s 8.2% growth.
Image Source: Zacks Investment Research
Mirikizumab is currently approved in Canada, Europe and Japan for treating moderately to severely active ulcerative colitis (“UC”), where the drug is marketed under the trade name Omvoh. A regulatory filing for the drug in UC indication is under FDA review, with a decision expected before this year’s end.
The targeted CD markets are highly competitive. If approved, Lilly will face stiff competition from AbbVie (ABBV - Free Report) , which markets its own drug Skyrizi, which utilizes a similar mechanism of action to treat CD. A blockbuster IL-23 inhibitor, AbbVie’s Skyrizi received label expansion in the United States and Europe last year in CD indication.
Last month, ABBV reported data from a head-to-head phase III study that compared Skyrizi to J&J’s Stelara in CD indication. This study achieved all its primary and secondary endpoints, thereby demonstrating the superiority of the AbbVie drug over J&J’s.
In August, AbbVie submitted a regulatory filing with the EMA and FDA seeking label expansion for Skyrizi in UC indication. Apart from CD, the AbbVie drug is approved for two other symptoms, namely active psoriatic arthritis and moderate-to-severe psoriasis, by both of these regulatory agencies.
In the past 60 days, estimates for Corcept Therapeutics’ 2023 earnings per share increased from 75 cents to 78 cents. During the same period, the earnings estimates per share for 2024 have improved from 81 cents to 83 cents. Year to date, shares of Corcept Therapeutics have risen 36.0%.
Earnings of Corcept Therapeutics beat estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing an average earnings surprise of 6.99%. In the last reported quarter, Corcept Therapeutics’ earnings beat estimates by 66.67%.
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Eli Lilly's (LLY) Mirikizumab Meets Crohn's Disease Study Goals
Eli Lilly (LLY - Free Report) announced encouraging data from the phase III VIVID-1 study, which evaluated its IL-23p19 antibody mirikizumab for adult patients with moderate-to-severe Crohn’s disease (“CD”).
The VIVID-1 study achieved its co-primary and all major secondary endpoints. Mirikizumab demonstrated clinical remission and endoscopic response in CD patients following a 52-week treatment period, compared to placebo.
A form of inflammatory bowel disease, CD can cause inflammation in the digestive tract, leading to diarrhea, abdominal pain, fatigue and weight loss.
Per Lilly, 51.4% of study participants who received mirikizumab achieved clinical remission, compared with 19.6% for those on placebo. Treatment with the drug also demonstrated non-inferiority compared to J&J’s (JNJ - Free Report) blockbuster drug Stelara (ustekinumab) in CD indication.
Treatment with the Lilly drug did not achieve superiority in the endoscopic response endpoint compared with J&J’s Stelara. However, management did mention that the mirikizumab results were ‘numerically higher’ compared with the J&J drug.
Based on the above data, Lilly will submit a regulatory filing with the FDA and other regulatory agencies worldwide next year, seeking approval for mirikizumab in CD indication.
Shares of Eli Lilly have surged 66.9% year to date compared with the industry’s 8.2% growth.
Image Source: Zacks Investment Research
Mirikizumab is currently approved in Canada, Europe and Japan for treating moderately to severely active ulcerative colitis (“UC”), where the drug is marketed under the trade name Omvoh. A regulatory filing for the drug in UC indication is under FDA review, with a decision expected before this year’s end.
The targeted CD markets are highly competitive. If approved, Lilly will face stiff competition from AbbVie (ABBV - Free Report) , which markets its own drug Skyrizi, which utilizes a similar mechanism of action to treat CD. A blockbuster IL-23 inhibitor, AbbVie’s Skyrizi received label expansion in the United States and Europe last year in CD indication.
Last month, ABBV reported data from a head-to-head phase III study that compared Skyrizi to J&J’s Stelara in CD indication. This study achieved all its primary and secondary endpoints, thereby demonstrating the superiority of the AbbVie drug over J&J’s.
In August, AbbVie submitted a regulatory filing with the EMA and FDA seeking label expansion for Skyrizi in UC indication. Apart from CD, the AbbVie drug is approved for two other symptoms, namely active psoriatic arthritis and moderate-to-severe psoriasis, by both of these regulatory agencies.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank & Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Corcept Therapeutics (CORT - Free Report) , which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Corcept Therapeutics’ 2023 earnings per share increased from 75 cents to 78 cents. During the same period, the earnings estimates per share for 2024 have improved from 81 cents to 83 cents. Year to date, shares of Corcept Therapeutics have risen 36.0%.
Earnings of Corcept Therapeutics beat estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing an average earnings surprise of 6.99%. In the last reported quarter, Corcept Therapeutics’ earnings beat estimates by 66.67%.