Cyber Extortion Group Claims Novo Nordisk Data Theft; FDA Reverses Stance on UniQure Drug

A cyber extortion group identified as FulcrumSec has claimed to have stolen more than a terabyte of data from Novo Nordisk. The group, which emerged in October 2025, stated it spent over two months within Novo Nordisk's networks to acquire the information.

FulcrumSec alleges the stolen data includes company source code, proprietary information on both released and unreleased drugs, trial data, and details pertaining to employees, doctors, and patients. The group also claims to have acquired information related to company processing facilities and internal AI model data. According to FulcrumSec, an unsuccessful demand for $25 million was made to Novo Nordisk, and the group is now exploring selling parts of the stolen data.

In a separate development, the U.S. Food and Drug Administration (FDA) has reversed its previous opposition to a closely watched experimental treatment for Huntington's disease. This decision now allows UniQure to proceed with filing for marketing approval for its therapy.

The FDA's change in stance followed a recent meeting where the agency agreed that a three-year analysis of an early-stage study, which demonstrated a benefit for patients with Huntington's disease, would be "acceptable" to support a marketing application. This marks a significant shift, as the same data were previously deemed insufficient for marketing approval by former FDA officials, including Commissioner Marty Makary and the agency's top regulator of cell and gene therapies, Vinay Prasad.

(Source: STAT News)