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BioNTech SE news coverage focuses on clinical trial results, regulatory milestones, strategic partnerships, and pipeline developments across oncology and infectious disease programs. Investors and healthcare professionals monitor announcements related to the company's mRNA-based cancer vaccines and infectious disease vaccine programs.
Clinical data releases generate significant attention, particularly results from late-stage trials evaluating personalized cancer vaccines in combination with checkpoint inhibitors. Updates on individualized neoantigen therapy programs provide insights into the potential of personalized medicine approaches in oncology. Off-the-shelf cancer vaccine data, such as results from melanoma trials, inform market expectations for broader cancer vaccine applications.
Partnership announcements and strategic collaborations frequently make headlines, as these transactions shape the company's development capabilities and commercial potential. Collaborations with major pharmaceutical companies on bispecific antibodies and other oncology assets expand the pipeline while sharing development costs. Acquisitions of biotechnology companies with complementary mRNA technologies or novel therapeutic platforms strengthen the company's technological infrastructure.
Regulatory developments, including clinical trial initiations, regulatory submissions, and approval decisions, drive news flow. Infectious disease vaccine updates, particularly variant-adapted formulations and new vaccine programs targeting diseases with high unmet need, attract media attention. Manufacturing expansions, capacity investments, and supply agreements also feature in coverage.
Financial results and corporate updates provide insights into revenue trends, research spending, and strategic priorities. Analyst coverage examines the commercial potential of pipeline assets and assesses the company's progress toward becoming a multi-product biotechnology company. Patent developments, intellectual property matters, and competitive landscape dynamics also generate news coverage.
Conference presentations at major medical and investor conferences offer detailed scientific updates on ongoing programs. Data presented at oncology conferences such as AACR and ASCO provide the research community with insights into the mechanism of action and clinical activity of investigational therapies.
BioNTech (Nasdaq: BNTX) closed its exchange offer to acquire CureVac on December 18, 2025, after a Subsequent Offering Period expired at 12:01 a.m. ET.
Approximately 86.75% of CureVac shares were validly tendered; BioNTech expects to complete compulsory acquisition of remaining shares in January 2026. CureVac shares will no longer trade following the post-offer reorganization. Management changes at CureVac were implemented with former CureVac board members voluntarily resigning and three BioNTech executives appointed to the CureVac management board.
BioNTech said the acquisition complements its proprietary capabilities in mRNA design, delivery formulations, and mRNA manufacturing and supports its oncology strategy, including joint development of pumitamig (BNT327/BMS986545) with Bristol Myers Squibb.
BioNTech (Nasdaq: BNTX) and Bristol Myers Squibb announced interim global Phase 2 data for pumitamig (BNT327/BMS986545), a PD-L1xVEGF-A bispecific antibody, combined with chemotherapy in locally advanced/metastatic triple-negative breast cancer (TNBC) as of the October 1, 2025 cut-off.
Key results in 39 efficacy-evaluable 1L/2L patients (Cohort 1): confirmed ORR 61.5%, unconfirmed ORR 71.8%, DCR 92.3%, and 9-month PFS rate 59.3%. Efficacy was similar across PD-L1 levels (CPS ≥10 and <10). Grade ≥3 treatment-related adverse events occurred in ~38–43% of patients; no pumitamig-related deaths were reported. Data support dose selection for the pivotal Phase 3 ROSETTA BREAST-01 trial.
BioNTech (Nasdaq: BNTX) and OncoC4 reported that selective Treg modulator gotistobart (BNT316/ONC-392) showed a clinically meaningful overall survival benefit versus docetaxel in the non-pivotal stage of the global Phase 3 PRESERVE-003 trial in previously treated metastatic squamous NSCLC.
At a 14.5-month median follow-up, median OS with gotistobart was not reached versus 10 months with docetaxel; 12-month OS was 63.1% vs 30.3%. Hazard ratio for death was 0.46 (95% CI 0.25–0.84) with nominal p=0.0102. Safety remained manageable; grade ≥3 TRAEs were 42.2% vs 48.8%.
BioNTech (Nasdaq: BNTX) announced that the minimum condition for its exchange offer for CureVac (Nasdaq: CVAC) has been satisfied after 184,071,410 CureVac shares (approximately 81.74% of issued and outstanding shares) were validly tendered before the initial period expired on Dec 3, 2025.
All validly tendered shares have been accepted and closing conditions for the post-offer reorganization are satisfied. BioNTech will deliver BioNTech ADSs (or cash in lieu of fractional ADSs) to tendering holders. A subsequent offering period runs until 12:01 a.m. ET on Dec 18, 2025. Non-tendering holders will receive ADSs (or cash) via reorganization and generally face a 15% Dutch dividend withholding tax; non-tendering shares will cease to be tradable post-reorganization.
BioNTech (Nasdaq: BNTX) announced key details and timing for its exchange offer for all outstanding CureVac shares (Nasdaq: CVAC).
The Offer is set to expire at 9:00 a.m. Eastern Time on December 3, 2025; CureVac shareholders are advised to tender by 6:00 p.m. ET on December 2, 2025 due to operational deadlines. The announced Exchange Ratio is 0.05363 BioNTech ADS per CureVac share, based on a 10‑day VWAP of BioNTech ADS of $101.88 (ending November 25, 2025).
At CureVac’s EGM on November 25, 2025, over 99.16% of votes cast approved the Offer‑related proposals. The Offer requires at least 80% valid tendered shares to close (may be reduced to 75% after four extensions). Non‑tendering holders who receive ADSs will generally face a 15% Dutch dividend withholding tax.
BioNTech (Nasdaq: BNTX) reported Q3 2025 revenue of €1,518.9 million, a year-over-year increase, and a Q3 net loss of €28.7 million (basic/diluted loss per share €0.12). Year-to-date revenues reached €1,962.5 million and cash, cash equivalents and securities totaled €16,704.9 million as of September 30, 2025. The company received a $1.5 billion payment from its Bristol Myers Squibb collaboration and raised full-year 2025 revenue guidance to €2.6–2.8 billion while lowering R&D, SG&A and capex guidance ranges. Operationally, interim Phase 2 pumitamig data in ES-SCLC showed encouraging anti-tumor activity and a manageable safety profile, and BioNTech launched a variant-adapted COVID-19 vaccine for the 2025/2026 season.
BioNTech (Nasdaq: BNTX) will host an Innovation Series R&D Day on Tuesday, November 11, 2025 at 09:00 a.m. EST (3:00 p.m. CET) in New York City. Company leadership will provide an overview of BioNTech’s strategy and clinical progress across its pipeline.
Investors, analysts and the public can join the event online via webcast; a replay will be available shortly after the event and archived on the company website for one year. Presentation slides will be posted on the Investor Relations “Events & Presentations” page at www.BioNTech.com.
BioNTech (Nasdaq: BNTX) will release its third quarter 2025 financial results on Monday, November 3, 2025. A live conference call and webcast for investors, analysts and the public will be held at 8:00 a.m. EST (2:00 p.m. CET) to discuss results and provide a corporate update.
Participants must register in advance to access telephone dial‑in numbers and a PIN; registration is recommended at least one day before the call. The slide presentation and live audio will be available on BioNTech's Investor Relations "Events & Presentations" page at www.BioNTech.com. A replay will be archived on the company website for 30 days after the call.
BioNTech (Nasdaq: BNTX) commenced a public exchange offer to acquire all outstanding CureVac shares (Nasdaq: CVAC) via an all‑stock transaction.
Each CureVac share will be exchanged for approximately $5.46 in BioNTech ADSs, implying an aggregate equity value of about $1.25 billion. The consideration is subject to a collar: 10‑day VWAP triggers of $126.55 and $84.37 set Exchange Ratios of 0.04318 and 0.06476 ADSs, respectively. The Offer expires at 9:00 a.m. NY on December 3, 2025, is conditioned on required regulatory approvals and at least 80% tender (may be reduced to 75% in certain cases), and includes a planned CureVac EGM on November 25, 2025.
BioNTech (NASDAQ: BNTX) has announced its second AI Day event, part of the company's Innovation Series, scheduled for October 1, 2025, at 9:00 AM EDT in London. The event will showcase BioNTech's artificial intelligence strategy and capabilities, particularly focusing on AI applications in their pipeline and internal processes.
The presentation will be accessible through a live webcast, with slides and recording available on BioNTech's Investor Relations website for one year following the event. This event marks a significant milestone in BioNTech's continued focus on AI development, following their acquisition of InstaDeep Ltd.
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