Judge Allows Novo Nordisk CagriSema Lawsuit to Proceed
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- A federal judge allowed parts of a shareholder lawsuit against Novo Nordisk to proceed over the obesity drug CagriSema, finding investors plausibly alleged some statements about the drug's tolerability and late-stage REDEFINE-1 trial design may have been misleading.
- CagriSema's December 2024 topline results showed average weight loss of about 20.4%, below the roughly 25% investors expected, sending Novo's American depositary receipts down $18.15 (17.83%) in a single day and its Copenhagen-listed shares down 20.7%.
- Shareholders alleged they weren't told the REDEFINE-1 trial used flexible dosing rather than requiring participants to escalate to the maximum level, with only 57% of participants ultimately reaching the highest dose.
- Judge Robert Kirsch rejected most of the shareholders' allegations but let claims over CagriSema's tolerability and trial protocols continue, including statements from Martin Holst Lange, Novo's former EVP of development and current chief scientific officer, writing that pharma companies 'cannot mischaracterize or omit important aspects of clinical trials in a misleading way.'
- Novo Nordisk called the allegations 'meritless' and said it will 'vigorously defend' against them as the case moves into discovery, while the company also faces mounting competition from Eli Lilly and is counting on CagriSema, higher-dose Wegovy, and oral formulations to defend its obesity market position.
Why it matters: Novo is betting its obesity pipeline on CagriSema as Eli Lilly's rival drugs erode Wegovy's market share. The December 2024 result — 20.4% weight loss versus the ~25% expected — wiped 17.83% off Novo's ADRs and 20.7% off its Copenhagen shares in one day, and discovery now puts internal REDEFINE-1 trial communications under legal scrutiny during a critical stretch for investor confidence.
