We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
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.
BMY Gets EC Nod for Opdivo Plus Yervoy in First-Line Colorectal Cancer
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission has approved the combination of its blockbuster immuno-oncology drug Opdivo (nivolumab) and Yervoy (ipilimumab) for a new cancer indication.
The EC has approved Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).
Following the latest nod, Opdivo plus Yervoy became the first dual checkpoint inhibitor therapy to be approved for the first-line treatment of MSI-H/dMMR mCRC in the European Union.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo plus Yervoy for the given indication in November.
Year to date, shares of Bristol Myers have rallied 12.2% against the industry’s decline of 13.7%.
Image Source: Zacks Investment Research
Approval Based on BMY's CheckMate -8HW Study
The latest approval for Opdivo plus Yervoy in first-line MSI-H/dMMR mCRC was based on data from the phase III CheckMate -8HW study.
Data from the same showed that treatment with the combo of Opdivo plus Yervoy led to a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS) and reduced the risk of disease progression or death by 79% versus the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review.
Also, the safety profile of Opdivo plus Yervoy was similar to that seen in previously reported data, with no new safety signals observed.
Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and the EU.
Opdivo, a key growth driver for BMY, is already approved for various oncology indications, and label expansion of this drug should fuel sales. Opdivo generated global sales of $6.8 billion in the first nine months of 2024.
BMY's Sotyktu Meets Goal in Psoriatic Arthritis Study
In a separate press release, Bristol Myers announced positive top-line data from two phase III studies that evaluated Sotyktu (deucravacitinib) for treating adults with active psoriatic arthritis (PsA).
Both the POETYK PsA-1 and POETYK PsA-2 studies met the primary endpoint as data from the same showed that a significantly greater proportion of patients who were treated with Sotyktu achieved ACR20 response (at least a 20% improvement in signs and symptoms of disease) following 16 weeks of treatment versus placebo.
Both studies also met important secondary endpoints across PsA disease activity at week 16.
Sotyktu, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is currently approved in several countries for treating adults with moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy.
BMY's Zacks Rank & Other Key Picks
Bristol Myers currently carries a Zacks Rank #2 (Buy).
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.80 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.33 to $1.57 during the same time. Year to date, shares of IMCR have declined 58.8%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Loss per share estimates for 2025 have narrowed from $1.54 to 79 cents during the same time. Year to date, shares of SPRO have declined 37.2%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 59 cents to earnings of 34 cents. Loss per share estimates for 2025 have narrowed from $2.15 to $1.84 during the same time. Year to date, shares of CSTL have surged 27.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
BMY Gets EC Nod for Opdivo Plus Yervoy in First-Line Colorectal Cancer
Bristol Myers Squibb (BMY - Free Report) announced that the European Commission has approved the combination of its blockbuster immuno-oncology drug Opdivo (nivolumab) and Yervoy (ipilimumab) for a new cancer indication.
The EC has approved Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).
Following the latest nod, Opdivo plus Yervoy became the first dual checkpoint inhibitor therapy to be approved for the first-line treatment of MSI-H/dMMR mCRC in the European Union.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo plus Yervoy for the given indication in November.
Year to date, shares of Bristol Myers have rallied 12.2% against the industry’s decline of 13.7%.
Image Source: Zacks Investment Research
Approval Based on BMY's CheckMate -8HW Study
The latest approval for Opdivo plus Yervoy in first-line MSI-H/dMMR mCRC was based on data from the phase III CheckMate -8HW study.
Data from the same showed that treatment with the combo of Opdivo plus Yervoy led to a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS) and reduced the risk of disease progression or death by 79% versus the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review.
Also, the safety profile of Opdivo plus Yervoy was similar to that seen in previously reported data, with no new safety signals observed.
Opdivo is approved both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and the EU.
Opdivo, a key growth driver for BMY, is already approved for various oncology indications, and label expansion of this drug should fuel sales. Opdivo generated global sales of $6.8 billion in the first nine months of 2024.
BMY's Sotyktu Meets Goal in Psoriatic Arthritis Study
In a separate press release, Bristol Myers announced positive top-line data from two phase III studies that evaluated Sotyktu (deucravacitinib) for treating adults with active psoriatic arthritis (PsA).
Both the POETYK PsA-1 and POETYK PsA-2 studies met the primary endpoint as data from the same showed that a significantly greater proportion of patients who were treated with Sotyktu achieved ACR20 response (at least a 20% improvement in signs and symptoms of disease) following 16 weeks of treatment versus placebo.
Both studies also met important secondary endpoints across PsA disease activity at week 16.
Sotyktu, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is currently approved in several countries for treating adults with moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy.
BMY's Zacks Rank & Other Key Picks
Bristol Myers currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the biotech sector are Immunocore Holdings plc (IMCR - Free Report) , Spero Therapeutics, Inc. (SPRO - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.80 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.33 to $1.57 during the same time. Year to date, shares of IMCR have declined 58.8%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Loss per share estimates for 2025 have narrowed from $1.54 to 79 cents during the same time. Year to date, shares of SPRO have declined 37.2%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 59 cents to earnings of 34 cents. Loss per share estimates for 2025 have narrowed from $2.15 to $1.84 during the same time. Year to date, shares of CSTL have surged 27.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.