BioNTech Balances ASCO Data Momentum with Looming First US Oncology Filing

The coming months could mark a watershed for BioNTech. While its ASCO presentation in Chicago grabbed headlines with high response rates for pumitamig, the company’s real prize sits further down the track: a Biologics License Application for Trastuzumab Pamirtecan (BNT323), planned for later in 2026. That filing, submitted jointly with partner DualityBio, would be the first oncology approval for the German biotech on US soil and comes with Fast Track and Breakthrough Therapy designations for endometrial cancer. A parallel application is already under review by China’s NMPA.

The ASCO data, however, provided a fresh jolt of credibility to the broader pipeline. The bispecific immunomodulator pumitamig, developed alongside Bristol Myers Squibb, delivered stand-out results in the Phase 2 Rosetta-Lung02 trial for first-line non-small cell lung cancer. In the selected 1400-mg dose cohort, the objective response rate reached 63.6% in non-squamous tumors and 72.2% in squamous histology. More striking was the performance across PD-L1 subgroups — a 47.6% response in PD-L1-negative patients, 77.8% in low expressors, and a perfect 100% in those with high PD-L1 levels. BioNTech is pursuing an “all-comers” strategy, aiming for a label that bypasses the current PD-L1 stratification that complicates first-line lung cancer treatment.

These results mark the third consistent dataset for pumitamig, following earlier signals in small-cell lung cancer and triple-negative breast cancer. A Phase 3 study now pits the pumitamig-chemo combination directly against the standard of care, pembrolizumab plus chemotherapy. The partnership with BMS carries potential milestone payments of up to $7.6 billion, underscoring the commercial weight both companies assign to the asset.

Should investors sell immediately? Or is it worth buying BioNTech?

In a separate oral presentation at ASCO, BioNTech and partner OncoC4 highlighted gotistobart, a CTLA-4 antibody, which showed durable activity in heavily pre-treated patients with platinum-resistant ovarian cancer. The overall survival benefit was described as clinically meaningful.

Financially, the company is navigating a transition that demands heavy investment. Cash and equivalents stood at €16.8 billion at the end of March, providing ample runway. Yet the near-term revenue picture is squeezed: BioNTech forecasts full-year 2026 sales of €2.0–2.3 billion, down from €2.9 billion a year earlier, as COVID-19 vaccine income continues to fade. The R&D budget is set between €2.2 billion and €2.5 billion, and the first quarter recorded a net loss of €531.9 million, or €2.10 per share. No oncology revenue is expected until 2027. To offset the spending, the company has begun consolidation measures targeting annual savings of roughly €500 million from 2029 onward.

The pipeline itself is expanding rapidly. BioNTech aims to have 15 ongoing Phase 3 trials by the end of 2026, with five new studies for pumitamig alone across different indications. Seven late-stage data readouts are scheduled for this year, and the BLA submission for Trastuzumab Pamirtecan — which already posted a 47.9% response rate and median progression-free survival of 8.1 months in a Phase 2 endometrial cancer study — remains the headline regulatory event.

Shares closed the week at €82.35, up 2.7% on Friday and roughly 3% higher on the week following the ASCO data. That still leaves the stock 19% below its 52-week high of €101.90 and down about 17% year-to-date. Of 17 analysts covering the equity, the consensus is “Buy” with an average price target of roughly $125 equivalent — implying more than 38% upside from current levels. An analyst upgraded the program shortly before the ASCO presentation, helping to firm sentiment. But bridging the valuation gap to last year’s level will ultimately depend on how convincingly the Phase 3 data stack up. The next quarterly numbers, due on 4 August, may offer a clearer view on the BLA timeline.

Ad

BioNTech Stock: New Analysis - 1 June

Fresh BioNTech information released. What's the impact for investors? Our latest independent report examines recent figures and market trends.

Read our updated BioNTech analysis...

en | US09075V1026 | BIONTECH | boerse | 69460706 |