BioNTech, COVID-19 and FDA
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BioNTech's colorectal cancer vaccine just collapsed in a Phase 2 trial, dragging Moderna down with it despite last week's melanoma triumph, and the fallout is forcing investors to rethink how far mRNA technology can actually reach into solid tumors.
Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
Data indicate that the 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, induces a strong immune response against contemporary
In August 2026, Pfizer and BioNTech received U.S. FDA approval for their updated COMIRNATY COVID-19 vaccine targeting the XFG variant for high-risk individuals, while Pfizer and Valneva’s Lyme disease vaccine candidate PF-07307405 had its Marketing Authorization Application validated by the European Medicines Agency based on Phase 3 trial data.
BioNTech SE maintains a Strong Buy rating, driven by robust late-stage oncology pipeline momentum and strategic partnerships. Click for more on BNTX.