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Bristol Myers' (BMY) Zeposia Fails Crohn's Disease Study
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Bristol Myers (BMY - Free Report) announced that a late-stage study on orally-administered Zeposia (ozanimod) in Crohn’s disease (CD) indication failed to achieve its primary endpoint.
This late-stage study was the first of the two induction studies in the phase III YELLOWSTONE clinical program, which evaluated Zeposia in 600 adult patients with moderate to severe active CD over a 12-week treatment period. Initial results from the study showed that treatment with Zeposia failed to meet the primary endpoint of clinical remission at week 12.
However, Bristol Myers did not report any numerical data/figures from the study, nor did it provide an update on its plans for the drug in CD indication. Management plans to share the full results from this study at a future medical meeting.
Apart from the induction studies, the YELLOWSTONE clinical program also includes a 52-week maintenance study and an optional 264-week, open-label extension (OLE) study.
CD is a chronic inflammatory bowel disease that causes inflammation in the digestive tract. Common disease symptoms include diarrhea, abdominal pain, fatigue and weight loss.
Year to date, Bristol Myers’ shares have risen 5.7% compared with the industry’s 0.5% growth.
Image Source: Zacks Investment Research
A sphingosine 1-phosphate (S1P) receptor modulator,Zeposia is currently approved in the United States and Europe for two indications, namely multiple sclerosis (MS) and ulcerative colitis (UC).
The Bristol Myers drug faces stiff competition from Pfizer’s (PFE - Free Report) S1P receptor modulator, Velsipity (etrasimod), which was approved by the FDA last year in UC indication. etrasimod is being evaluated in multiple clinical stages for immuno-inflammatory indications. Apart from UC, Pfizer is also evaluating etrasimod in separate mid-stage studies across multiple gastroenterology and dermatology indications, including alopecia areata, atopic dermatitis, CD and eosinophilic esophagitis.
The FDA granted label expansion to AbbVie’s (ABBV - Free Report) blockbuster JAK inhibitor Rinvoq last year for use in certain adult patients with moderately to severely active CD. Following this approval, the AbbVie drug became the first approved oral product to treat this indication.
S1P receptor modulators like Zeposia and Pfizer’s Velsipity represent a different mechanism of action than available UC therapies (like AbbVie’s Rinvoq and J&J’s Stelara) and represent a new treatment option that can provide symptom relief and remission to patients. Per BMY, an S1P modulator is yet to achieve success in a late-stage study for CD indication.
In a separate press release, Bristol Myers also announced results from the pivotal late-stage KRYSTAL-12 study, evaluating Krazati (adagrasib) in pre-treated patients with KRASG12C-mutated non-small cell lung cancer (NSCLC). This study met its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) compared with standard-of-care chemotherapy.
We remind investors that Krazati was granted accelerated approval by the FDA to treat adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC. The KRYSTAL-12 study is intended to serve as a confirmatory study seeking to convert this accelerated approval to a full one.
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 46.0%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
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Bristol Myers' (BMY) Zeposia Fails Crohn's Disease Study
Bristol Myers (BMY - Free Report) announced that a late-stage study on orally-administered Zeposia (ozanimod) in Crohn’s disease (CD) indication failed to achieve its primary endpoint.
This late-stage study was the first of the two induction studies in the phase III YELLOWSTONE clinical program, which evaluated Zeposia in 600 adult patients with moderate to severe active CD over a 12-week treatment period. Initial results from the study showed that treatment with Zeposia failed to meet the primary endpoint of clinical remission at week 12.
However, Bristol Myers did not report any numerical data/figures from the study, nor did it provide an update on its plans for the drug in CD indication. Management plans to share the full results from this study at a future medical meeting.
Apart from the induction studies, the YELLOWSTONE clinical program also includes a 52-week maintenance study and an optional 264-week, open-label extension (OLE) study.
CD is a chronic inflammatory bowel disease that causes inflammation in the digestive tract. Common disease symptoms include diarrhea, abdominal pain, fatigue and weight loss.
Year to date, Bristol Myers’ shares have risen 5.7% compared with the industry’s 0.5% growth.
Image Source: Zacks Investment Research
A sphingosine 1-phosphate (S1P) receptor modulator,Zeposia is currently approved in the United States and Europe for two indications, namely multiple sclerosis (MS) and ulcerative colitis (UC).
The Bristol Myers drug faces stiff competition from Pfizer’s (PFE - Free Report) S1P receptor modulator, Velsipity (etrasimod), which was approved by the FDA last year in UC indication. etrasimod is being evaluated in multiple clinical stages for immuno-inflammatory indications. Apart from UC, Pfizer is also evaluating etrasimod in separate mid-stage studies across multiple gastroenterology and dermatology indications, including alopecia areata, atopic dermatitis, CD and eosinophilic esophagitis.
The FDA granted label expansion to AbbVie’s (ABBV - Free Report) blockbuster JAK inhibitor Rinvoq last year for use in certain adult patients with moderately to severely active CD. Following this approval, the AbbVie drug became the first approved oral product to treat this indication.
S1P receptor modulators like Zeposia and Pfizer’s Velsipity represent a different mechanism of action than available UC therapies (like AbbVie’s Rinvoq and J&J’s Stelara) and represent a new treatment option that can provide symptom relief and remission to patients. Per BMY, an S1P modulator is yet to achieve success in a late-stage study for CD indication.
In a separate press release, Bristol Myers also announced results from the pivotal late-stage KRYSTAL-12 study, evaluating Krazati (adagrasib) in pre-treated patients with KRASG12C-mutated non-small cell lung cancer (NSCLC). This study met its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) compared with standard-of-care chemotherapy.
We remind investors that Krazati was granted accelerated approval by the FDA to treat adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC. The KRYSTAL-12 study is intended to serve as a confirmatory study seeking to convert this accelerated approval to a full one.
Bristol Myers Squibb Company Price
Bristol Myers Squibb Company price | Bristol Myers Squibb Company Quote
Zacks Rank & A Key Pick
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 46.0%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.