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Can BMY's First CELMoD Approval Support Its Growth Strategy?
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Key Takeaways
Bristol Myers won FDA accelerated approval for Zenbexus in multiple myeloma after one prior therapy.
Zenbexus doubled MRD-negative complete response rates versus the daratumumab-based regimen in EXCALIBER-RRMM.
Bristol Myers is advancing protein degraders and has another CELMoD drug under FDA review.
Bristol Myers Squibb (BMY - Free Report) recently announced that the FDA has granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd).
The regimen, approved under the brand name Zenbexus, is approved for the treatment of adults with multiple myeloma who have received at least one prior line of therapy.
The full approval for this indication will be contingent upon verification and description of clinical benefit in the confirmatory trials.
Zenbexus is the first FDA-approved cereblon E3 ligase modulator (CELMoD), representing a novel class of cereblon-modulating protein degraders developed to treat multiple myeloma.
The approval was based on results from the EXCALIBER-RRMM study, which showed ZDd doubled minimal residual disease-negative complete response rates versus daratumumab, bortezomib and dexamethasone (41% vs. 21%) in relapsed or refractory multiple myeloma.
Per BMY, it is the only company to have successfully developed and commercialized protein degraders for multiple myeloma. Its immunomodulatory drugs (IMiDs) helped establish the current standard of care for this incurable disease. The company is advancing a broad pipeline of investigational protein degraders using three complementary approaches — CELMoD agents, ligand-directed degraders and degrader antibody conjugates.
By leveraging multiple degradation technologies, the company aims to target disease-causing proteins that were previously difficult to treat, expanding opportunities across hematology, oncology and other therapeutic areas.
Zenbexus is also being evaluated in the EXCALIBER Maintenance study.
While Zenbexus is the first FDA-approved CELMoD therapy, BMY has a new drug application under FDA review for investigational CELMoD mezigdomide in combination with carfilzomib and dexamethasone. The application has a target action date of May 13, 2027.
The company is reshaping its business to achieve sustained top-tier growth and maximize long-term value. The approval of new drugs brings an incremental stream of revenues to the company.
BMY’s Competition in Oncology Space
Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space.
The company competes with big pharma giants like Merck (MRK - Free Report) and Pfizer (PFE - Free Report) in this space.
The immuno-oncology space is dominated by pharma giant MRK’s blockbuster drug Keytruda (pembrolizumab).
Keytruda is approved for several types of cancer and alone accounts for around 48% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda.
Pfizer is one of the largest and most successful drugmakers in the field of oncology. It has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immune-oncology biologics that treat a wide range of cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, including lung cancer.
Pfizer’s position in oncology was strengthened with the addition of Seagen.
The company inked a licensing agreement with 3SBio for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, outside China.
BMY’s Price Performance, Valuation & Estimates
Shares of Bristol Myers have gained 18% year to date compared with the industry’s growth of 5.2%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, shares currently trade at 9.79X forward earnings, higher than its mean of 8.63X but lower than the large-cap pharma industry’s 18.73X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.81 from $6.32 in the past 60 days, while that for 2027 has moved north to $6.42 from $6.05 in the same time frame.
View the Zacks #1 Rank List
Image: Shutterstock
Can BMY's First CELMoD Approval Support Its Growth Strategy?
Key Takeaways
Bristol Myers Squibb (BMY - Free Report) recently announced that the FDA has granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd).
The regimen, approved under the brand name Zenbexus, is approved for the treatment of adults with multiple myeloma who have received at least one prior line of therapy.
The full approval for this indication will be contingent upon verification and description of clinical benefit in the confirmatory trials.
Zenbexus is the first FDA-approved cereblon E3 ligase modulator (CELMoD), representing a novel class of cereblon-modulating protein degraders developed to treat multiple myeloma.
The approval was based on results from the EXCALIBER-RRMM study, which showed ZDd doubled minimal residual disease-negative complete response rates versus daratumumab, bortezomib and dexamethasone (41% vs. 21%) in relapsed or refractory multiple myeloma.
Per BMY, it is the only company to have successfully developed and commercialized protein degraders for multiple myeloma. Its immunomodulatory drugs (IMiDs) helped establish the current standard of care for this incurable disease. The company is advancing a broad pipeline of investigational protein degraders using three complementary approaches — CELMoD agents, ligand-directed degraders and degrader antibody conjugates.
By leveraging multiple degradation technologies, the company aims to target disease-causing proteins that were previously difficult to treat, expanding opportunities across hematology, oncology and other therapeutic areas.
Zenbexus is also being evaluated in the EXCALIBER Maintenance study.
While Zenbexus is the first FDA-approved CELMoD therapy, BMY has a new drug application under FDA review for investigational CELMoD mezigdomide in combination with carfilzomib and dexamethasone. The application has a target action date of May 13, 2027.
The company is reshaping its business to achieve sustained top-tier growth and maximize long-term value. The approval of new drugs brings an incremental stream of revenues to the company.
BMY’s Competition in Oncology Space
Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space.
The company competes with big pharma giants like Merck (MRK - Free Report) and Pfizer (PFE - Free Report) in this space.
The immuno-oncology space is dominated by pharma giant MRK’s blockbuster drug Keytruda (pembrolizumab).
Keytruda is approved for several types of cancer and alone accounts for around 48% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda.
Pfizer is one of the largest and most successful drugmakers in the field of oncology. It has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immune-oncology biologics that treat a wide range of cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, including lung cancer.
Pfizer’s position in oncology was strengthened with the addition of Seagen.
The company inked a licensing agreement with 3SBio for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, outside China.
BMY’s Price Performance, Valuation & Estimates
Shares of Bristol Myers have gained 18% year to date compared with the industry’s growth of 5.2%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, shares currently trade at 9.79X forward earnings, higher than its mean of 8.63X but lower than the large-cap pharma industry’s 18.73X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.81 from $6.32 in the past 60 days, while that for 2027 has moved north to $6.42 from $6.05 in the same time frame.
Image Source: Zacks Investment Research
BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.