Judge lets shareholder fraud claims over Novo's CagriSema proceed
Investors may argue Novo hid a REDEFINE 1 protocol change letting patients self-adjust doses, but efficacy-overstatement claims were dismissed.
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By Daniel Okafor · Regulatory Correspondent
Jul 29 03:00 ETSource: BioSpace
The wire
- 01U.S. District Judge Robert Kirsch in New Jersey ruled investors can pursue claims that Novo Nordisk concealed flexible dosing in REDEFINE 1, where under 60% of patients completed dose escalation.
- 02The dosing detail bears on how clinicians read CagriSema's 22.7% weight loss at 68 weeks versus 2.3% on placebo, and on its tolerability profile.
- 03Novo calls the claims meritless and will defend them; CagriSema was filed for approval in December 2025 with no announced action date.
From the source
Read at biospace.comNovo ordered to face CagriSema fraud claims from shareholders: New Jersey court
Novo Nordisk will need to answer allegations that it potentially defrauded shareholders over the next-generation weight loss therapy CagriSema.
