STAT+: Pharmalittle: We’re reading about hackers extorting Novo, an FDA about-face, and more

FulcrumSec, which emerged in October 2025, stated it spent more than two months accessing Novo Nordisk's networks, exfiltrating data that includes company source code, proprietary information on current and future drugs, trial data, employee and patient records, information on processing facilities, and internal AI model data.

This incident highlights the growing threat of cyberattacks targeting pharmaceutical companies and their sensitive intellectual property.

In a separate development, the U.S. Food and Drug Administration (FDA) reversed its previous stance against an experimental treatment for Huntington's disease, paving the way for UniQure to seek marketing approval. The FDA's change of heart followed a meeting where the agency deemed a three-year analysis of an early-stage study, which indicated patient benefit, as sufficient to support a marketing application.

This decision contrasts with earlier assessments by former FDA officials, including Marty Makary and Vinay Prasad, who had previously found the data insufficient for such a purpose. The reversal signifies a potential breakthrough for Huntington's disease patients and the biotechnology sector.