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Bristol Myers lawsuit over delayed cancer drug revived by appeals court

Created at 13 Aug · 5:34 PM1 source↑ Market-relevant
IN SHORT

A U.S. federal appeals court revived a $6.7 billion lawsuit accusing Bristol Myers Squibb of cheating former Celgene shareholders by delaying FDA approval for three drugs, including the cancer treatment Breyanzi.

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Key Numbers

$6.7 billionlawsuit value
$80.3 billionCelgene purchase price
$9extra cash per share for CVR holders
threedrugs at issue
five weekslate for Breyanzi approval deadline

Who's Involved

Bristol Myers Squibb
Defendant in $6.7 billion lawsuit over drug approval delays
Celgene shareholders
Accusers in lawsuit over delayed drug approvals
UMB Bank
Trustee representing Celgene shareholders in lawsuit
Jesse Furman
U.S. District Judge who initially dismissed the lawsuit
Beth Robinson
Circuit Judge on the 2nd U.S. Circuit Court of Appeals

↳ Why This Matters

The revival of this significant lawsuit highlights potential accountability for pharmaceutical companies regarding drug approval timelines and shareholder agreements, impacting investor confidence and the valuation of contingent value rights in future M&A deals.

Key facts

  • A $6.7 billion lawsuit against Bristol Myers Squibb has been revived by a U.S. federal appeals court.
  • The lawsuit accuses the company of cheating former Celgene shareholders by delaying FDA approval for three drugs.
  • One of the delayed drugs is the cancer treatment Breyanzi.
  • The 2nd U.S. Circuit Court of Appeals ruled that UMB Bank can represent Celgene shareholders.
  • The appeals court overturned a previous dismissal by U.S. District Judge Jesse Furman.

A U.S. federal appeals court has revived a $6.7 billion lawsuit against Bristol Myers Squibb, alleging the company defrauded former Celgene shareholders by intentionally delaying the U.S. Food and Drug Administration's approval for three drugs, including the cancer treatment Breyanzi.

The 2nd U.S. Circuit Court of Appeals in Manhattan ruled 3-0 that UMB Bank, acting as a trustee, is entitled to represent the Celgene shareholders in the case. This decision overturns a September 2024 dismissal by U.S. District Judge Jesse Furman.

The lawsuit stems from Bristol Myers' $80.3 billion acquisition of Celgene in 2019. Celgene shareholders holding "contingent value rights" (CVRs) were promised an additional $9 per share if specific drugs, including Liso-cel (Breyanzi), Ozanimod, and Ide-cel, received timely FDA approval. Concerns arose that Bristol Myers might miss these deadlines, prompting CVR holders to appoint UMB as a new trustee.

UMB accused Bristol Myers of not making diligent efforts to secure approvals and of delisting the CVRs prematurely. Bristol Myers secured FDA approval for Breyanzi in February 2021, five weeks after the deadline stipulated in the CVR agreement. The company has denied these allegations, stating it did not intentionally delay the approval process or undermine CVR holders' rights.

The appeals court clarified that UMB had standing to sue, as Bristol Myers was aware of the investors appointing the bank, despite a technicality in the CVR agreement regarding registered ownership. Judge Jesse Furman had previously allowed UMB to proceed with some claims, including breach of contract and bad faith, in December.

Frequently asked questions

The lawsuit accuses Bristol Myers Squibb of cheating former Celgene shareholders by delaying FDA approval for three drugs, including the cancer treatment Breyanzi, to avoid paying out additional cash promised under contingent value rights.

The 2nd U.S. Circuit Court of Appeals revived the $6.7 billion lawsuit, overturning a previous dismissal and allowing UMB Bank to represent the Celgene shareholders.

A CVR is a contractual clause in an acquisition that entitles former shareholders to additional payments if certain milestones, such as drug approvals, are met by a specified deadline.

No, Bristol Myers has denied claims that it intentionally slowed down the approval process or undermined the rights of CVR holders.

What Happens Next

01The case will likely proceed in the lower court for further proceedings.
02Bristol Myers may face renewed scrutiny over its drug development and approval processes.

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Cadence

How It Developed

A lawsuit accused Bristol Myers Squibb of cheating former Celgene shareholders.
The lawsuit alleged delays in FDA approval for three drugs, including Breyanzi.
A U.S. federal appeals court revived the $6.7 billion lawsuit.
The appeals court ruled that UMB Bank could represent Celgene shareholders.
A previous dismissal by a U.S. District Judge was overturned.
Bristol Myers denied claims of slow-rolling the approval process.

Sources

T1
Lawsuit against Bristol Myers over delayed cancer drug is revivedReuters

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