BioNTech shares drop 10% after terminating colorectal cancer mRNA trial
BioNTech SE (NASDAQ: BNTX) shares tumbled roughly 10% on Friday, erasing gains made during a broader mRNA rally earlier in the week. The decline followed the company’s announcement that it has terminated its Phase 2 trial (BNT122‑01) of the mRNA cancer vaccine autogene cevumeran, developed jointly with Genentech, as an adjuvant monotherapy for patients with surgically resected, high‑risk Stage II/III colorectal cancer.
An independent Data Safety Monitoring Board identified a numerical imbalance in overall survival between the treatment and control arms and concluded that continuing the study would not alter the efficacy outcome. Although the trial’s futility boundary was originally crossed in October 2025, the data were initially deemed too immature to halt the study until the recent decision.
Chief Medical Officer Prof. Özlem Türeci said the outcome “provides scientific insight into the challenges of treating immunotherapy‑insensitive tumor types with immune‑suppressive microenvironments.”
Financially, BioNTech reported €16.6 billion in cash and securities at the end of Q2 2026, providing a substantial runway despite posting a net loss of €820.8 million for the quarter.
The setback does not affect BioNTech’s Phase 2 pancreatic cancer trial (IMcode003), which evaluates the vaccine in combination with checkpoint inhibition and chemotherapy and remains on schedule. Investors will look to the European Society for Medical Oncology (ESMO) Congress in October 2026 for a side‑by‑side presentation of data from both BioNTech and Moderna, as well as the forthcoming interim analysis of BioNTech’s BNT113 trial in head‑and‑neck cancer, a disease type that is highly immunotherapy‑sensitive.
The timing of the failure is starkly contrasted with recent successes from competitors: last week Moderna and Merck announced a landmark Phase 3 result for their mRNA vaccine combined with Keytruda in melanoma, propelling Moderna’s share price up 177% and lifting BioNTech shares in sympathy prior to the termination news.