We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol Myers (BMY) UC Candidate Fails in Phase II Study
Read MoreHide Full Article
Bristol Myers (BMY - Free Report) recently announced that the mid-stage study investigating pipeline candidate deucravacitinib for the treatment of moderate to severe ulcerative colitis (UC) has failed.
The phase II LATTICE-UC study is evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor compared to placebo in UC patients. The primary endpoint of the trial is clinical remission (using the modified Mayo score) at week 12. Secondary endpoints include a clinical response (using the modified Mayo score), endoscopic response, and histological improvement at week 12.
The study did not meet the primary efficacy endpoint of clinical remission at week 12, nor secondary efficacy endpoints.
Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease. Phase III studies exploring the potential of deucravacitinib in psoriatic arthritis are currently underway. Bristol Myers continues to evaluate the potential of deucravacitinib in UC in IM011-127, a second phase II study that includes a higher dose.
The safety profile of deucravacitinib in the LATTICE-UC study was consistent with previously reported studies in psoriasis and psoriatic arthritis, and no new safety signals were observed.
Bristol Myers remains hopeful about the prospects of the candidate and reiterated that it expects greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.
Earlier in the year, Bristol Myers announced positive results from two phase III studies evaluating deucravacitinib for the treatment of patients with moderate to severe plaque psoriasis. In the studies, deucravacitinib demonstrated superior skin clearance compared with Amgen’s (AMGN - Free Report) Otezla.
We remind investors that Bristol Myers had to let go off Otezla when it acquired Celgene in light of concerns about a possible overlap expressed by the U.S. Federal Trade Commission.
Hence, the failure of the study was disappointing.
Bristol Myers’ shares have declined 4.8% so far this year compared with the industry’s 10.8% decrease.
Image Source: Zacks Investment Research
The successful development of other drugs will diversify its revenue base. Bristol Myers’ performance has revived of late as Opdivo sales returned to growth after a slowdown. The stellar performance of key drugs, Revlimid and Eliquis, is maintaining the company’s momentum.
The label expansion of Opdivo into indications of lung cancer and gastric cancer should propel its sales and offset the decline from recent setbacks. However, competition is very stiff for Opdivo for its various approved indications from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.
Image: Shutterstock
Bristol Myers (BMY) UC Candidate Fails in Phase II Study
Bristol Myers (BMY - Free Report) recently announced that the mid-stage study investigating pipeline candidate deucravacitinib for the treatment of moderate to severe ulcerative colitis (UC) has failed.
The phase II LATTICE-UC study is evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor compared to placebo in UC patients. The primary endpoint of the trial is clinical remission (using the modified Mayo score) at week 12. Secondary endpoints include a clinical response (using the modified Mayo score), endoscopic response, and histological improvement at week 12.
The study did not meet the primary efficacy endpoint of clinical remission at week 12, nor secondary efficacy endpoints.
Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease. Phase III studies exploring the potential of deucravacitinib in psoriatic arthritis are currently underway. Bristol Myers continues to evaluate the potential of deucravacitinib in UC in IM011-127, a second phase II study that includes a higher dose.
The safety profile of deucravacitinib in the LATTICE-UC study was consistent with previously reported studies in psoriasis and psoriatic arthritis, and no new safety signals were observed.
Bristol Myers remains hopeful about the prospects of the candidate and reiterated that it expects greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.
Earlier in the year, Bristol Myers announced positive results from two phase III studies evaluating deucravacitinib for the treatment of patients with moderate to severe plaque psoriasis. In the studies, deucravacitinib demonstrated superior skin clearance compared with Amgen’s (AMGN - Free Report) Otezla.
We remind investors that Bristol Myers had to let go off Otezla when it acquired Celgene in light of concerns about a possible overlap expressed by the U.S. Federal Trade Commission.
Hence, the failure of the study was disappointing.
Bristol Myers’ shares have declined 4.8% so far this year compared with the industry’s 10.8% decrease.
The successful development of other drugs will diversify its revenue base.
Bristol Myers’ performance has revived of late as Opdivo sales returned to growth after a slowdown. The stellar performance of key drugs, Revlimid and Eliquis, is maintaining the company’s momentum.
The label expansion of Opdivo into indications of lung cancer and gastric cancer should propel its sales and offset the decline from recent setbacks. However, competition is very stiff for Opdivo for its various approved indications from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.
Bristol Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.