BMY Reports Positive Data From a Late-Stage Multiple Myeloma Study

Bristol Myers Squibb BMY announced positive data from the late-stage study on iberdomide in patients with relapsed or refractory multiple myeloma (RRMM).

The phase III EXCALIBER-RRMM (NCT04975997) is a multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of iberdomide in combination with Darzalex (daratumumab) and dexamethasone (IberDd) versus Darzalex, bortezomib, and dexamethasone (DVd) in RRMM patients.

The study demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint.

More on BMY’s Late-Study on Iberdomide

The EXCALIBER-RRMM study is designed to assess dual-primary endpoints of MRD negativity and progression-free survival (PFS). Additional secondary endpoints include overall survival (OS), overall response rate, duration of response, time to progression, time to next treatment, and health-related quality of life (HR-QoL).

Data from the study showed that the safety profile of iberdomide in combination with daratumumab and dexamethasone is generally consistent with previous studies.

BMY stated that the study will continue without changes to evaluate the other dual primary endpoint of PFS and the key secondary endpoint of OS and safety, in accordance with the trial design and based on the recommendations from the Data Monitoring Committee.

Per BMY, iberdomide represents the first of a novel class of medicines, called CELMoDs, which has the potential to create a new foundation for multiple myeloma treatment that may be combined with other therapies.  BMY plans to discuss these results with health authorities.

BMY’s Efforts to Broaden Portfolio

BMY’s Growth Portfolio comprises drugs like Opdivo, Opdivo Qvantig, Orencia, Yervoy, Reblozyl, Camzyos, Breyanzi, Opdualag, Zeposia, Abecma, Sotyku, Krazati and Cobenfy.

Bristol Myers is looking to expand its pipeline/portfolio, as the legacy portfolio is being adversely impacted due to the continued generic impact on Revlimid, Pomalyst, Sprycel, and Abraxane.

Shares of Bristol Myers have lost 17.8% year to date against the industry’s growth of 5.2%.

BMY collaborated with BioNTech BNTX in June 2025. Pumitamig is being jointly developed by BioNTech and BMY.  

BMY and partner BNTX recently presented interim data from a global randomized mid-stage study evaluating pumitamig plus chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC).

Pumitamig is a novel investigational bispecific antibody, combining two complementary, validated mechanisms in oncology into one single molecule. The interim analysis included 43 patients with untreated ES-SCLC (Cohort 1) who received pumitamig in combination with standard-of-care chemotherapy at two dose levels. Data from the phase II study showed a 76.3% confirmed objective response rate, 100% disease control rate and a median progression-free survival of 6.8 months.

The positive data underscore the efficacy of the combination and confirm the dose selection for the ongoing global pivotal late-stage ROSETTA LUNG-01 study.

BMY had earlier won FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia, in adults. The drug was approved under the brand name Cobenfy.

The approval of Cobenfy for schizophrenia broadens BMY’s portfolio and validates the acquisition of Karuna Therapeutics.

Cobenfy represents the first new pharmacological approach to treating schizophrenia in decades.

Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline.

BMY's Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Halozyme Therapeutics HALO and ANI Pharmaceuticals, Inc. ANIP, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Halozyme Therapeutics

The Zacks Consensus Estimate for 2025 EPS has increased 70 cents to $6.18 in the past 90 days. Shares of Halozyme have surged 62.3% year to date.

HALO’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.74%.

ANI Pharmaceuticals

ANIP’s shares have gained 72.5% so far this year. Earnings estimates for 2025 have risen 82 cents in the past 60 days. ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.

 

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