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BioNTech SE (BNTX) SEC Filings, Aug-Sep 2026

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BioNTech SE (BNTX) reports that Chief Executive Officer and ten percent owner Ugur Sahin sold 20,500 Ordinary Shares on September 10, 2026 in an open-market or private transaction at $96.31 per share, under a Rule 10b5-1 trading plan established on June 3, 2026. Following this sale, he holds 688,209 Ordinary Shares directly and 39,218,111 Ordinary Shares indirectly through Medine GmbH, including 106,721 shares held in trust where Medine GmbH has voting but not dispositive power and Sahin may be deemed to beneficially own those shares.

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BioNTech SE (BNTX) reported that Chief Executive Officer and ten percent owner Ugur Sahin sold ordinary shares in two open-market or private transactions under a pre-arranged Rule 10b5-1 trading plan established on June 3, 2026. On September 8 and 9, 2026 he sold an aggregate of 73,000 ordinary shares. An indirectly held position of 39,218,111 ordinary shares, mainly through Medine GmbH, is reported after these transactions.

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BioNTech SE (BNTX) reported that Chief Executive Officer Ugur Sahin sold a total of 76,500 Ordinary Shares in open-market transactions pursuant to a Rule 10b5-1 trading plan established on June 3, 2026. The sales occurred on September 3 and September 4, 2026 at prices just above $102 and $103 per share.

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BioNTech SE (BNTX) received a Rule 144 notice that Medine GmbH intends to sell up to 858,209 American Depositary Shares representing ordinary shares, to be sold through Berenberg Capital Markets LLC. The filing lists an aggregate market value of $89,090,676.29 for these securities and notes that BioNTech had 251,204,366 shares outstanding.

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BioNTech SE (BNTX) has decided to terminate its Phase 2 colorectal cancer trial BNT122-01 (NCT04486378) of autogene cevumeran, an individualized mRNA cancer immunotherapy given as adjuvant monotherapy to ctDNA‑positive, surgically resected Stage II (high risk) and Stage III colorectal cancer patients. The decision, made in consultation with Genentech, follows a new recommendation from the independent Data Safety Monitoring Board, which identified a numerical imbalance in overall survival between treatment arms and concluded that further continuation was unlikely to change the efficacy outcome. No new safety signals were observed, and investigators and regulators have been informed. BioNTech plans a thorough data analysis to guide future mRNA oncology development, while the separate Phase 2 IMcode003 trial of autogene cevumeran in adjuvant pancreatic cancer in combination with checkpoint inhibition and chemotherapy continues as planned.

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BioNTech SE (BNTX) reports that, together with Pfizer, it has received U.S. FDA approval of a supplemental Biologics License Application for the 2026‑2027 COVID‑19 vaccine formula targeting the XFG variant, marketed as COMIRNATY XFG. The vaccine is authorized for adults 65 years and older, and for individuals 5 through 64 years who have at least one underlying condition that places them at high risk for severe COVID‑19 outcomes.

The approval is supported by a cumulative package of clinical, non‑clinical and real‑world data on COMIRNATY’s safety and effectiveness, plus manufacturing and non‑clinical data showing that the XFG‑adapted vaccine generated strong immune responses against circulating SARS‑CoV‑2 variants including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. BioNTech states that shipments for the upcoming season will begin immediately across U.S. pharmacies, hospitals and clinics, and notes that more than five billion doses of COMIRNATY have been distributed globally to date. The companies also highlight extensive safety monitoring and outline numerous forward‑looking risks related to commercial demand, regulatory decisions and competitive dynamics.

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BioNTech SE (BNTX) announced that it will present new clinical data from its lung cancer development program at the IASLC 2026 World Conference on Lung Cancer in Seoul from September 12-15, 2026. The presentations will focus on key assets pumitamig (BNT327/BMS986545), gotistobart (BNT316/ONC-392), the B7H3-targeted ADC elfetabart drozuntecan (BNT324/DB-1311), and the mRNA cancer immunotherapy BNT116.

Highlights include first global data for a novel-novel combination of pumitamig, a PD-(L)1xVEGF bispecific immunomodulator, with elfetabart drozuntecan in advanced or metastatic SCLC and NSCLC, and updated overall survival data from stage 1 of the Phase 3 PRESERVE-003 trial of gotistobart in metastatic squamous NSCLC after PD-(L)1 progression. BioNTech reports a diversified lung cancer pipeline with 16 ongoing clinical trials, including five Phase 3 and two novel-novel combination trials.

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BioNTech SE reported revenue of €223.7 million for the six months ended June 30, 2026 and a net loss of €1,352.7 million, or €5.34 per share. COVID‑19 vaccine revenue was €118.8 million, down from €286.3 million a year earlier, mainly due to lower dose volumes, while other revenues were largely driven by a German pandemic preparedness contract.

An operating loss of €1,625.6 million reflected higher R&D spending of €1,108.0 million and significant pipeline prioritization charges, including €126.9 million of intangible impairments and €96.1 million of property, plant and equipment impairments tied to manufacturing footprint consolidation. Provisions rose to €293.5 million, including €133.3 million for restructuring. Despite the loss, liquidity remained strong with €9,741.0 million in cash and €16,634.2 million in cash, cash equivalents and security investments. The company repurchased 1,693,056 ADSs for €131.8 million and announced that Guido Oelkers will succeed Prof. Ugur Sahin as CEO by February 1, 2027.

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BioNTech SE reported sharply lower COVID-19 revenue and larger losses for the three and six months ended June 30, 2026, while advancing its oncology pipeline and updating guidance. Q2 2026 revenue was €105.6 million and net loss €820.8 million, with diluted loss per share of €3.24. First-half revenue was €223.7 million and net loss €1,352.7 million, mainly reflecting reduced demand for COVID-19 vaccines and higher R&D and SG&A spending.

The company cut its 2026 revenue outlook to €1.6–1.9 billion from €2.0–2.3 billion and trimmed adjusted R&D guidance to €2.0–2.3 billion, while keeping adjusted SG&A at €700–800 million. BioNTech ended June with €16.6 billion in cash and investments and has repurchased 1,693,056 ADSs under its up-to-$1.0 billion buyback. It received European Commission approval for an XFG variant-adapted COVID-19 vaccine and now counts 14 ongoing pivotal oncology trials, including for pumitamig, gotistobart and multiple antibody-drug conjugates. The Supervisory Board has appointed Guido Oelkers as next CEO, to take office by February 1, 2027, succeeding Prof. Ugur Sahin.

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BioNTech SE announced that its Supervisory Board has appointed Guido Oelkers, Ph.D. to the Management Board as Chief Executive Officer, succeeding Prof. Ugur Sahin, M.D. Oelkers will take office by February 1, 2027 at the latest, following a comprehensive selection process.

Oelkers currently serves as CEO of Swedish Orphan Biovitrum AB, where he more than quadrupled revenues over financial years 2017 to 2026 and strengthened its late-stage pipeline. Prof. Sahin and Chief Medical Officer Prof. Özlem Türeci will transition to manage a new independent company, while BioNTech continues searching for a new CMO.

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FAQ

How many BioNTech SE (BNTX) SEC filings are available on StockTitan?

StockTitan tracks 95 SEC filings for BioNTech SE (BNTX), including 20-F annual reports and 6-K reports. Each filing includes AI-generated summaries, impact scoring, and sentiment analysis.

When was the most recent SEC filing for BioNTech SE (BNTX)?

The most recent SEC filing for BioNTech SE (BNTX) was filed on September 11, 2026.