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 (ROSETTA HNSCC-205): Start of global pivotal trial in first-line HNSCC (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: pumitamig (ROSETTA HNSCC-205) — Start of global pivotal trial in first-line HNSCC (2026). 5 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
- Nov 3, 2026mixed Trastuzumab pamirtecan met the primary endpoint in HR+/HER2-low breast cancer with statistically significant, yet modest PFS improvement versus chemotherapy; higher rate of ILD observed.
The global Phase 3 clinical trial DYNASTY-Breast02 to evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low metastatic breast cancer met its primary endpoint demonstrating a statistically significant, yet modest improvement in progression-free survival compared to investigator's cho
Filing - Nov 3, 2026started BioNTech advanced first global Phase 3 trial of pumitamig in combination with Gilead's TROP2-directed ADC sacituzumab govitecan in triple-negative breast cancer, pending regulatory approval.
BioNTech entered into a clinical trial collaboration and supply agreement with Gilead Sciences Inc. to evaluate pumitamig in combination with the TROP2-directed ADC sacituzumab govitecan as first-line treatment for patients with PD-L1 low or negative locally advanced or metastatic TNBC in the ROSETT
Filing - Nov 3, 2026discontinued Early termination was initiated in the Phase 2 trial of autogene cevumeran as adjuvant treatment for ctDNA-positive, surgically resected Stage II/III colorectal cancer.
Early termination was initiated in a randomized Phase 2 clinical trial to evaluate autogene cevumeran as an adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II (high risk)/Stage III CRC compared to watchful waiting after surgery and chemotherapy.
Filing
18 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
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
- Summit Therapeutics Inc. SMMT
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.