A federal judge in Manhattan denied Bayer's bid for an injunction that would have blocked Johnson & Johnson from publicizing claims that its prostate cancer therapy Erleada reduces the risk of death by about half compared with Bayer's Nubeqa.
In a written ruling issued late on a Friday, U.S. District Judge Dale Ho concluded that Bayer had not carried its burden to show a likelihood of success on the merits of its lawsuit. Bayer had argued that Johnson & Johnson's promotional campaign contained false statements and that those statements caused irreparable harm and risked undermining confidence in Bayer's own treatment.
Bayer filed the complaint on February 23, saying Johnson & Johnson asserted a "51% reduction in risk of death" for patients treated with Erleada instead of Nubeqa, and that such a claim relied on testing performed under what Johnson & Johnson characterized as "rigorous" U.S. Food and Drug Administration standards. Bayer countered that the comparison was unreliable because the majority of Nubeqa patients in the analysis had received their medication off-label, and that the FDA had not vetted Johnson & Johnson's retrospective, real-world analysis as a substitute for conventional clinical trial evidence.
The decision spans 41 pages and found that Johnson & Johnson's external communications accurately reflected the conclusions of the study on which they relied. Judge Ho wrote that Bayer had not identified methodological flaws that were "so substantial" as to render Johnson & Johnson's statements materially false or misleading.
"Based on the current record," the judge wrote, "the methodological choices made by the authors of the study were not errant or out-of-step within the relevant scientific community."
Following the ruling, Bayer spokeswoman Sue Ann Pentecost said in a statement that Bayer still believes the totality of the evidence supports its advertising claims and that the company looks forward to the court's resolution of the case on its merits.
Johnson & Johnson responded by describing the ruling as a victory for scientific discourse and for patients. In its statement, the company emphasized that real-world evidence can aid clinicians in making treatment decisions when head-to-head clinical trial data are not available.
The competing commercial footprints for the two drugs were noted in the filings. Reported sales figures show Nubeqa generated 2.39 billion euros in 2025, which the reporting equated to about $2.81 billion, while Erleada's sales totaled $3.57 billion in the same year.
The filings also included public health context: roughly 313,780 men in the United States received a prostate cancer diagnosis in 2025 and about 35,770 died from the disease that year, figures attributed to the National Cancer Institute.
The lawsuit and the court's rejection of an injunction leave the parties to pursue the underlying litigation toward a determination on the merits. Bayer has signaled it intends to continue its case, asserting that its false advertising claims remain supported by the broader evidentiary record.
Context and next steps
- The court's injunction denial does not decide the ultimate question of whether Johnson & Johnson's advertising was false; it ruled only that Bayer had not demonstrated a likelihood of prevailing at this preliminary stage.
- Bayer has indicated it will press forward with the case so the substantive allegations can be resolved by the court.
- Johnson & Johnson has highlighted the role of real-world evidence in clinical decision-making where direct trial comparisons are lacking.