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U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

Key Takeaway: The U.S. FDA has granted accelerated approval for Bristol Myers Squibb's ZENBEXUS, the company's first CELMoD therapy. This therapy is approved for use in combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) in patients with multiple myeloma, particularly as early as the first relapse. This marks a significant advancement in treatment options for this patient population.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA grants accelerated approval for ZENBEXUS therapy.
  • Combination therapy shows promise for multiple myeloma patients.
  • First CELMoD therapy from Bristol Myers Squibb.

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+42%
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1.9%
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Lead asset
Muraglitazar
Phase 3 · Type 2 Diabetes

Full Press Release Details

PRINCETON, N.J.--(BUSINESS WIRE)---- $BMY #CELMoD--U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS

Frequently Asked Questions

What is ZENBEXUS?

ZENBEXUS is Bristol Myers Squibb's first CELMoD therapy approved for multiple myeloma.

What combination is ZENBEXUS used with?

ZENBEXUS is used in combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone.

Who is the target patient group for ZENBEXUS?

ZENBEXUS is targeted at multiple myeloma patients, especially those experiencing early relapse.

What type of FDA approval did ZENBEXUS receive?

ZENBEXUS received accelerated approval from the U.S. FDA.

Last updated: Aug 13, 2026