BioNTech SE (NASDAQ:BNTX) shares are dropping Friday after the company announced it will terminate its Phase 2 clinical trial of autogene cevumeran in resected colorectal cancer. Here’s what you should know.
- BioNTech stock is feeling bearish pressure. What’s behind BNTX decline?
BioNTech Ends Phase 2 Colorectal Cancer Trial
BioNTech is shutting down BNT122-01, a mid-stage study testing autogene cevumeran, its experimental personalized mRNA cancer treatment, as a solo therapy for patients whose colorectal cancer had been surgically removed but still showed circulating tumor DNA. Roche unit Genentech co-developed the treatment alongside BioNTech, and the two companies reached the termination decision together.
The trial had already tripped a futility threshold back in October 2025, but the study’s independent safety monitors felt the data was too premature at the time to draw firm conclusions, so BioNTech kept the trial running. A more recent review changed that: the safety board found a gap in overall survival between treated and untreated patients and concluded that continuing wouldn’t meaningfully change the outcome, leading it to recommend ending the study.
The trial was testing whether the mRNA treatment, used alone without a checkpoint inhibitor, could prevent cancer recurrence better than standard monitoring in this high-risk group.
BioNTech Co-Founder and Chief Medical Officer Özlem Türeci said the outcome wasn’t what the company hoped for, but that it offers useful insight into treating immune-resistant tumors and will help guide future mRNA cancer research. She said BioNTech remains committed to mRNA as a core part of its oncology strategy, including combination approaches, and thanked those involved in the study.
BioNTech Plans Further Analysis, Other Trial Unaffected
BioNTech said it plans to analyze the trial data further to inform future mRNA cancer treatment development, with results to be shared publicly later. Separately, the company’s other autogene cevumeran trial, IMcode003, which pairs the drug with checkpoint inhibitors and chemotherapy for pancreatic cancer, is unaffected and will continue as planned.
BNTX Shares Are Tumbling
BNTX Price Action: BioNTech shares were down 6.94% at $103.68 at the time of publication on Friday, according to Benzinga Pro.
Image: Piotr Swat/Shutterstock
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