BioNTech SE BNTX
BioNTech SE (Nasdaq: BNTX) is an oncology drug developer. Its lead program, pumitamig, is in Phase 3 for Multiple solid tumors incl. ES-SCLC, NSCLC, TNBC (Phase 3 ROSETTA trials). Its next catalyst on record is pumitamig: New clinical data from late-stage oncology pipeline (16 abstracts) at ESMO 2026 (October 2026).
Upcoming catalysts
- October 2026pumitamig — New clinical data from late-stage oncology pipeline (16 abstracts) at ESMO 2026
it will present new clinical data from its late-stage oncology pipeline with 16 abstracts spanning the Company’s tumor focus areas, including lung and breast cancer, at the European Society for Medical Oncology (“ESMO”) 2026 Congress held in Madrid, Spain, from October 23–27, 2026.
Next further out: pumitamig (ROSETTA Lung-02 Phase 2/3) — Data from the Phase 2 part (2026). 9 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| pumitamig (bispecific antibody) | ES-SCLC, SCLC, NSCLC, TNBC, CRC, gastric, HCC, HNSCC and others | antibody | Phase 3 |
| trastuzumab pamirtecan (BNT323/DB-1303) | HR+/HER2-low breast cancer; advanced endometrial cancer | antibody | Phase 3 |
| gotistobart (BNT316/ONC-392) | Metastatic NSCLC (PRESERVE-003) | antibody | Phase 3 |
| BNT113 | PD-L1+, HPV16+ head and neck squamous cell carcinoma (AHEAD-MERIT Phase 2/3) | RNA (siRNA/ASO/mRNA) | Phase 3 |
| BNT324/DB-1311 | Metastatic CRPC and other solid tumors (B7H3 ADC) | antibody | Phase 3 |
| autogene cevumeran (BNT122) | Adjuvant ctDNA+ colorectal cancer; adjuvant PDAC | RNA (siRNA/ASO/mRNA) | Phase 2 |
| BNT116 | NSCLC | RNA (siRNA/ASO/mRNA) | Phase 2 |
| BNT325/DB-1305 | Advanced solid tumors (TROP2 ADC) | antibody | Phase 2 |
| BNT326/YL202 | Advanced solid tumors, NSCLC, breast cancer (HER3 ADC) | antibody | Phase 2 |
| BNT329 | Advanced solid tumors (CA19-9 ADC) | antibody | Phase 1 |
Recent results and decisions
- Oct 22, 2026n/a BioNTech enters clinical trial collaboration and supply agreement with Gilead Sciences to evaluate pumitamig in combination with sacituzumab govitecan in PD-L1 low or negative triple-negative breast cancer.
BioNTech today announced a clinical trial collaboration and supply agreement with Gilead Sciences Inc. to evaluate pumitamig in combination with the TROP2-directed antibody-drug conjugate sacituzumab govitecan as first-line treatment for patients with locally advanced or metastatic PD-L1 low or nega
Filing - Jan 13, 2026n/a FDA Orphan Drug designation granted to gotistobart in January 2026 (indication not specified in deck).
FDA Orphan drug designation granted Jan 2026
Filing - Jan 13, 2026positive PRESERVE-003 stage 1: gotistobart reduced risk of death by 54% vs docetaxel (OS HR 0.46, 95% CI 0.25-0.84, nominal p=0.01; not from formal hypothesis); previously presented at NACLC 2025.
PRESERVE-003 trial stage 1 data: gotistobart1 reduces risk of death by 54% compared with docetaxel
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.