BioNTech Lifts 2026 Revenue Outlook as Lung Data Shine and a Breast Candidate Stalls

BioNTech closed the third quarter of 2026 with a net profit of EUR 184.5 million, yet the first nine months of the year still leave the German biotech nursing a net loss of EUR 1,168.2 million. Quarterly revenue came in at EUR 1,289.2 million, and the company raised the midpoint of its full-year 2026 sales guidance while narrowing the expected range to between EUR 1.7 billion and EUR 1.9 billion. Forecasts for adjusted research and development costs, as well as for selling and administrative expenses, were left untouched.

The financial update lands alongside a pair of oncology readouts that pull in opposite directions — one a closely watched lung-cancer signal, the other a breast-cancer result that arrives with strings attached.

A Lung Combination Delivers an Early Signal

On 25 October, BioNTech and Bristol Myers Squibb reported early findings from ROSETTA Lung-107, a Phase 2 study testing pumitamig in combination with docetaxel. The trial enrolled patients with advanced non-small cell lung cancer whose disease had progressed after a first-line regimen of immunotherapy and chemotherapy. At an early analysis, median progression-free survival reached 6.9 months, and the confirmed objective response rate stood at 36.7%, according to the two partners. The progression-free survival figure is explicitly preliminary.

Breast Cancer: Endpoint Met, Benefit Called Limited

Roughly a week earlier, BioNTech and DualityBio disclosed that trastuzumab pamirtecan had hit the primary endpoint of the Phase 3 DYNASTY-Breast02 trial. The study covered patients with metastatic, hormone-receptor-positive breast cancer with low HER2 expression. The improvement in progression-free survival over physician's choice of chemotherapy was statistically significant, but the companies characterized it as only moderate. Overall survival data were not yet mature.

Safety told a more complicated story. Interstitial lung disease occurred more frequently than in earlier trials, including a small share of grade 3 to 5 events; Reuters reported that these included severe and fatal cases. Weighing the available evidence, the partners described the potential benefit in the current treatment landscape as limited and said they would consult on next steps. The 26 October announcement therefore carried no decision on how the program will proceed.

Pushing Pumitamig Into a Third Indication

BioNTech is not standing still with its lung asset. About two weeks ago the company said it would advance a Phase 3 trial of pumitamig combined with Gilead's sacituzumab govitecan — marketed as Trodelvy — in triple-negative breast cancer. Under the arrangement reported by Reuters, BioNTech will sponsor and lead the study while Gilead supplies the drug. The planned protocol amendments still require regulatory approval.