Bristol Myers Squibb BMY recently announced that the FDA has accepted its new drug application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM).
The regulatory body has granted a target action date of May 13, 2027 for this indication.
Mezigdomide is an oral cereblon E3 ligase modulator, or CELMoD, for the treatment of multiple myeloma.
It was developed using BMY’s targeted protein degradation platform (TPD), built over two decades.
BMY boasts a deep and promising pipeline. Key pipeline candidates with multi-billion-dollar potential are milvexian (Oral factor XIa inhibitor), admilparant (LPA1 antagonist), pumitamig (PD-L1 x VEGF-A bispecific antibody) and iberdomide & mezigdomide (oral CELMoD protein degraders).
BMY is the only drugmaker to have successfully developed and commercialized protein degrader therapies for multiple myeloma through its immunomodulatory drugs (IMiDs), which have become a standard of care for the disease.
The company is advancing a broad pipeline of investigational protein degraders using three complementary approaches — CELMoD agents, ligand-directed degraders (LDDs) and degrader antibody conjugates (DACs). 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.
Mezigdomide is also being evaluated in the ongoing phase III SUCCESSOR-1 study versus standard of care regimen in relapsed or refractory multiple myeloma.
BMY’s pipeline also includes iberdomide, an investigational, oral CELMoD, in combination with daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma, and golcadomide, a potential first-in-class investigational CELMoD for lymphoma CELMoD.
The FDA has accepted a new drug application for iberdomide in combination with standard treatment (daratumumab and dexamethasone) for RRMM, granting Breakthrough Therapy Designation and Priority Review, with a target action date of Aug. 17, 2026.
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 and Pfizer PFE 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 55% 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 10% year to date compared with the industry’s growth of 3.3%.
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 9.58X forward earnings, higher than its mean of 8.61X but lower than the large-cap pharma industry’s 18.59X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 EPS has moved north to $6.32 from $6.30 in the past 60 days, while that for 2027 has moved north to $6.09 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.
Beyond Nvidia: AI's Second Wave Is Here
The AI revolution has already minted millionaires. But the stocks everyone knows about aren't likely to keep delivering the biggest profits. AI’s second wave is moving from infrastructure to implementation and these companies are at the forefront of this transition, positioned to become what Amazon and Google were to the internet era.
See Stocks Now >>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
Pfizer Inc. (PFE): Free Stock Analysis Report
Merck & Co., Inc. (MRK): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).