Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for patients with relapsed or refractory multiple myeloma (RRMM). The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of May 13, 2027, for this indication. The acceptance marks progress in the company's targeted protein degradation programs, addressing a persistent disease area.

The filing is supported by positive results from the Phase 3 SUCCESSOR-2 trial. The study demonstrated that MeziKd significantly improved progression-free survival (PFS) compared to the standard of care regimen (Kd). The data showed a median PFS of 18.0 months for MeziKd versus 8.3 months for Kd, representing a 52% reduction in the risk of disease progression or death (HR: 0.48; p<0.0001). The safety profile was consistent with prior studies of mezigdomide and the known profiles of the individual agents.

SUCCESSOR-2 Trial Details

The SUCCESSOR-2 trial is an inferential, seamless Phase 3, multicenter, randomized, open-label study. It evaluated the efficacy and safety of MeziKd versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma. The primary endpoint was progression-free survival.

The analysis included 479 patients, with 288 receiving MeziKd and 191 receiving Kd. The median age of patients was 68, with 25.1% aged 75 or older. Patients had received a median of two prior therapies. The study population was heavily pre-treated, with 92.1% of patients triple-class-exposed, 85.8% refractory to an anti-CD38 monoclonal antibody, and 75.8% refractory to lenalidomide.

Cristian Massacesi, MD, executive vice president, chief medical officer and head of development at Bristol Myers Squibb, highlighted the significance of the acceptance. He stated that the company now has two distinct agents under review for this indication and remains committed to leveraging its CELMoD platform to advance treatments for hematologic malignancies and solid tumors.

Mezigdomide is an oral cereblon E3 ligase modulator (CELMoD) optimized to degrade Ikaros and Aiolos target proteins. It is currently being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial as well. The results from the SUCCESSOR-2 trial were recently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The Lancet.

B of A Securities analyst Tim Anderson has maintained a Buy rating on Bristol-Myers Squibb, while lowering the price target from $67 to $66. The adjustment reflects the firm's updated valuation perspective on the pharmaceutical company's stock performance.

Separately, Cantor Fitzgerald analyst Carter Gould has reaffirmed a Neutral rating on Bristol-Myers Squibb, maintaining a price target of $54. This rating reiteration suggests that Cantor Fitzgerald sees limited immediate upside or downside risk at the current valuation levels.

Bristol-Myers Squibb continues to be monitored for its operational and financial developments.