BioNTech has laid out a sweeping strategic update, detailing its focus areas for 2026 and a dense slate of clinical milestones stretching from late-stage readouts to new Phase 3 trial launches.

 

“We concluded 2025 with strong momentum, driven by our execution in research and development, partnerships, acquisitions, and our financial strength. We continued to advance our next wave of innovation, including the initiation of novel-novel combination trials. These achievements have successfully positioned us as a late-stage biopharmaceutical company,” said Prof. Ugur Sahin, Chief Executive Officer and Co-Founder of BioNTech. 

 

“We see 2026 as a year when science translates into tangible results. We will report on a series of milestones, including readouts from late-stage trials and earlier trials evaluating novel-novel combinations, as well as new Phase 3 clinical trial initiations. If positive, they will help unlock our path towards multiple near- and mid-term product launch opportunities with the aim to benefit patients across cancer types.”

 

BioNTech is positioning 2026 as a defining year in its transition toward a multi-product oncology company. The company’s pipeline spans immunomodulators, antibody-drug conjugates (ADCs), and mRNA cancer immunotherapies, with several assets designed for pan-tumor use and novel–novel combination strategies.

 

Over the past two years, BioNTech has more than doubled the number of Phase 2 and Phase 3 oncology trials underway. It now has more than 25 late-stage studies in progress and plans to initiate six additional Phase 3 trials in 2026, bringing the expected total to 15. Seven late-stage data readouts are anticipated next year, data the company says will directly shape regulatory and launch strategies.

 

A major pillar of the 2026 strategy is combination therapy. BioNTech has more than ten novel–novel combination trials in development, with multiple data updates expected next year. Central to these efforts is various immunomodulators, ADCs, and mRNA cancer immunotherapies across a range of tumor types.

 

As its pipeline matures, BioNTech says it will increasingly organize development around specific disease areas rather than individual modalities, with a focus on lung, breast, gynecologic, gastrointestinal, and genitourinary cancers.

 

Among the most closely watched 2026 milestones are late-stage readouts for trastuzumab pamirtecan (T-Pam), gotistobart, BNT113, pumitamig, and autogene cevumeran across indications including breast, endometrial, lung, prostate, head and neck, colorectal, and triple-negative breast cancers. 

 

The company also expects a wave of early-stage data from pumitamig-based combinations with multiple ADCs, as well as several new Phase 3 trial initiations in colorectal, gastric, head and neck, and prostate cancers.

 

BioNTech plans to submit a biologics license application for T-Pam in second-line or later HER2-expressing endometrial cancer, a potential near-term regulatory milestone.

 

Looking further ahead, BioNTech expects at least 17 late-stage data readouts, including pivotal trials, by 2030 and beyond. The company says these studies are intended to underpin multiple product launches and cement its transformation into a diversified oncology player by the end of the decade.