BMY Gets EC Nod for Opdivo Plus Yervoy in First-Line Colorectal Cancer

Bristol Myers Squibb BMY 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 ResearchApproval Based on BMY's CheckMate -8HW StudyThe 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 StudyIn 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 PicksBristol Myers currently carries a Zacks Rank #2 (Buy).Some other top-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, 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%.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks