BioNTech SE Files Form 6-K for September 2025
Ticker: BNTX · Form: 6-K · Filed: Sep 5, 2025 · CIK: 1776985
| Field | Detail |
|---|---|
| Company | Biontech Se (BNTX) |
| Form Type | 6-K |
| Filed Date | Sep 5, 2025 |
| Risk Level | low |
| Pages | 1 |
| Reading Time | 1 min |
| Sentiment | neutral |
Sentiment: neutral
Topics: clinical-trial, collaboration, regulatory-filing
TL;DR
BioNTech SE filed a 6-K on Sep 5, 2025, detailing a Phase 3 trial with DualityBio.
AI Summary
On September 5, 2025, BioNTech SE announced a collaboration with Duality Biologics (Suzhou) Co., Ltd. ("DualityBio") regarding a pivotal Phase 3 trial, identified by NCT06265428. This filing is a Form 6-K report for the month of September 2025.
Why It Matters
This filing indicates ongoing clinical trial activities for BioNTech SE, potentially impacting future product development and market position.
Risk Assessment
Risk Level: low — The filing is a routine report of foreign private issuer activities and does not contain significant new financial or operational information that would immediately impact risk.
Key Players & Entities
- BioNTech SE (company) — Registrant and collaborator
- Duality Biologics (Suzhou) Co., Ltd. (company) — Collaborator
- NCT06265428 (trial_id) — Pivotal Phase 3 trial identifier
- September 5, 2025 (date) — Announcement date
FAQ
What is the purpose of this Form 6-K filing?
This Form 6-K is a report of foreign private issuer pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934, for the month of September 2025.
What significant event was announced on September 5, 2025?
On September 5, 2025, BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. announced a pivotal Phase 3 trial (NCT06265428).
What is the company's primary business classification?
The company's Standard Industrial Classification is Biological Products (No Diagnostic Substances) [2836].
Where is BioNTech SE located?
BioNTech SE's principal executive offices are located at An der Goldgrube 12, D-55131 Mainz, Germany.
Does BioNTech SE file annual reports under Form 20-F or Form 40-F?
BioNTech SE indicates it files annual reports under cover of Form 20-F.
Filing Stats: 302 words · 1 min read · ~1 pages · Grade level 15.4 · Accepted 2025-09-05 06:44:03
Filing Documents
- form6-kbnt3235sep2025.htm (6-K) — 14KB
- a99120250905_bnt323xdb-130.htm (EX-99.1) — 25KB
- image_0a.jpg (GRAPHIC) — 42KB
- image_1a.jpg (GRAPHIC) — 7KB
- 0001776985-25-000055.txt ( ) — 108KB
From the Filing
Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a16 OR 15d16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FOR THE MONTH OF SEPTEMBER 2025 COMMISSION FILE NUMBER 001-39081 BioNTech SE (Translation of registrant's name into English) An der Goldgrube 12 D-55131 Mainz Germany +49 6131-9084-0 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20F or Form 40F Form 20F Form 40F Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(1) Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(7) DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On September 5, 2025, BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. ("DualityBio") announced that the pivotal Phase 3 trial (NCT06265428) which DualityBio is conducting in China to evaluate trastuzumab pamirtecan (BNT323DB-1303) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of progression free survival at a pre-specified interim analysis. The press release is attached hereto as Exhibit 99.1. SIGNATURE Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BioNTech SE By s Ramn Zapata-Gomez By s Dr. Sierk Poetting Name Ramn Zapata-Gomez Name Dr. Sierk Poetting Title Chief Financial Officer Title Chief Operating Officer Date September 5, 2025 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer