Novo Nordisk's ocedurenone Phase III flop costs company $816m [Yahoo! Finance]
Novo Nordisk A/S (NVO)
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Source: Yahoo! Finance
The Phase III CLARION-CKD trial (NCT04968184) failed to meet its primary endpoint in patients with uncontrolled hypertension and moderate or severe (stage 3b/4) chronic kidney disease (CKD). The drug was acquired by the Danish pharma giant from KBP Biosciences last year in a $1.3bn deal. At the time of the acquisition, KBP Biosciences was already conducting the Phase III study. The company said that following the trial data, it recognises an impairment loss of $816m related to ocedurenone in Q2 2024. The trial design included a prespecified interim analysis by an independent data monitoring committee after 12 weeks of treatment. The analysis showed that the trial had not met its primary endpoint of change in systolic blood pressure (SBP), leading Novo to terminate the study. The trial was estimated to enrol approximately 600 patients from 150 sites in the US, Europe, and Asia, with the first patient dosed at the end of 2021. Novo had also announced plans to investigate the
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NVO
Earnings
- 5/3/24 - Beat
NVO
Sec Filings
- 6/26/24 - Form 6-K
- 6/24/24 - Form 6-K
- 6/21/24 - Form 11-K
- NVO's page on the SEC website