Advanced oncology pipeline in mid- and late-stage with plans to have ten or more potentially registrational oncology trials running by the end of 2024 Aiming for first oncology launch in 2026 and ten indication approvals by 2030 as part of BioNTech's strategy to develop combinatorial and synergistic therapeutic approaches Entered strategic collaborations with Biotheus, DualityBio, Medilink and OncoC4 to complement clinical... Read More

Mainz, Germany, March 20, 2024 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that the Supervisory Board has appointed Annemarie Hanekamp to the Management Board as Chief Commercial Officer effective July 1, 2024. She will join BioNTech from Novartis AG (“Novartis”) and succeed Sean Marett in this role. Annemarie Hanekamp is a seasoned pharmaceutical executive experienced in... Read More

MAINZ, Germany, March 11, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present clinical trial data for selected candidates from its oncology pipeline at the American Association for Cancer Research (“AACR”) Annual Meeting 2024 in San Diego, California, from April 5-10, 2024. The oral and poster presentations will feature BioNTech’s investigational mRNA-based cancer vaccine and novel investigational... Read More

Mainz, Germany, March 7, 2024 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that Sean Marett, Chief Business and Commercial Officer, will retire as planned from the Management Board of BioNTech. As of July 1, 2024, Sean Marett will continue as a specialist advisor to the Company at least until the end of the year. A new Chief Commercial Officer will be announced by the end of... Read More

MAINZ, Germany, March 6, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the full year and fourth quarter 2023 on Wednesday, March 20, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a... Read More

Strategic alliance leverages manufacturing and commercial infrastructure as well as technology with the aim to advance both companies’ autologous CAR-T programs towards market, pending market authorization BioNTech secures the right to utilize Autolus’ manufacturing capacity in a cost-efficient set-up to accelerate the development of BNT211 into pivotal trials in CLDN6+ tumors BioNTech to support launch and expansion of... Read More

Designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial in patients with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer 1 Fast Track designation can facilitate the development and expedite the regulatory review of BNT325/DB-1305 Ovarian cancer is the fourth most common gynecological tumor type 2 with over 300,000 cases diagnosed globally each... Read More

The pivotal Phase 3 trial with BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced solid tumors with early signs of anti-tumor activity in heavily pretreated patients with HER2-low and HER2-positive breast cancer The trial is expected to enroll 532 patients with Hormone Receptor-positive (“HR+”) and HER2-low metastatic... Read More

Plans to have ten or more potentially registrational trials by the end of 2024 Preparing to be commercial-ready by the end of 2025 Ended 2023 with approximately €17.5 billion (unaudited) in cash, cash equivalents and security investments Expects full year 2024 revenues of approximately €3 billion Presentation and webcast at the 42 nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 6:00 p.m. CET/... Read More

Designation is based on Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced endometrial cancer with encouraging early signs of anti-tumor activity Breakthrough Therapy designation will allow for an expedited development and regulatory review of BNT323/DB-1303 Endometrial or uterine cancer is the second most common gynecologic cancer globally with over... Read More

Set-up of first BioNTainer as high-tech manufacturing solution for mRNA medicines is a critical step in establishing a resilient vaccine ecosystem in Africa and future pandemic preparedness BioNTech plans to complete all buildings at the Kigali site and start local training of specialized personnel in the facility in 2024, with test mRNA production for process validation to be initiated in 2025 Upon successful validation,... Read More

MAINZ, Germany, December 12, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will inaugurate its first African site in Kigali, Rwanda, on Monday, December 18 th , 2023. The inauguration takes place on the occasion of the set-up of the containers for the first manufacturing unit called BioNTainer. BioNTech invites media and the general public to join a live stream of the event on the same day... Read More

Positive clinical data updates across multiple drug classes including antibody-drug conjugate (ADC) candidates BNT323/DB-1303, BNT325/DB-1305, CAR-T candidate BNT211, T cell therapy candidate BNT221 and mRNA cancer vaccine candidate BNT116 Progress across the oncology pipeline with multiple late-stage trials initiated since third quarter start New and expanded strategic collaborations reflect BioNTech's commitment to... Read More

Lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains Safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine The companies plan to start a pivotal Phase 3 trial in the coming months NEW YORK & MAINZ, GERMANY / Oct 26, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) and BioNTech SE... Read More

BNT211 combines two innovative approaches in one regimen with first-in-class potential: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (“CARVac”) Data presented at ESMO Congress 2023 demonstrates that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells BNT211 continues to show... Read More

MAINZ, Germany, October 23, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter 2023 on Monday, November 6 th , 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update... Read More

Initiation of Phase 2 builds on data from a Phase 1 clinical trial evaluating the safety and tolerability of autogene cevumeran (BNT122, RO7198457) in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard of care chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC) The Phase 2 trial is expected to enroll approximately 260 patients with PDAC at clinical trial sites... Read More

Program updates include new data for investigational CAR-T and ex-vivo T cell therapies, a novel ADC, a FixVac off-the-shelf mRNA cancer vaccine, and a bi-specific antibody New data from BioNTech’s investigational autologous CAR-T therapy BNT211 demonstrate the potential of the Company’s innovative approach of combining an autologous CAR-T cell therapy targeting Claudin-6 (“CLDN6”) with a CLDN6-encoding CAR-T cell amplifying... Read More

MAINZ, Germany, October 16, 2023 (GLOBE NEWSWIRE) -- On October 13, 2023, Pfizer Inc. (NYSE: PFE, “Pfizer”), a collaboration partner of BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), announced a non-cash charge for inventory write-offs and other charges related to COMIRNATY of $0.9 billion. The Company has been informed by Pfizer that the majority of the write-offs relate to raw materials, mainly... Read More

COMIRNATY Omicron XBB.1.5-adapted monovalent COVID-19 vaccine is now authorized in Canada for individuals 6 months of age and older New Omicron XBB.1.5-adapted COVID-19 vaccine is administered as a single dose for individuals 5 years of age and older, regardless of COVID-19 vaccination history. In children 6 months through 4 years of age the vaccine is administered as a three-dose series in those without a history of... Read More

BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166 The Coalition for Epidemic Preparedness Innovations (CEPI) commits funding of up to $90 million for the development of vaccine candidates Data generated by this partnership will contribute to CEPI’s 100 Days Mission, a global effort to accelerate the development of well-tolerated and effective vaccines against future viral... Read More

The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older Recommendation is based on pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which continue to dominate... Read More

MAINZ, Germany, August 14, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced that the Supervisory Board has appointed James Ryan, Ph.D., to the Management Board as Chief Legal Officer (CLO), effective September 1, 2023. As part of the Management Board, James Ryan will continue to lead the Company’s corporate legal strategy and global legal operations including transactions, corporate governance,... Read More

Significant pipeline advancement highlighted by the initiation of BNT316/ONC-392 Phase 3 pivotal trial and multiple trials planned to start across the oncology portfolio Positive data updates across multiple technology platforms including ADC candidate BNT323/DB-1303, anti-CTLA4 monoclonal antibody candidate BNT316/ONC-392 and CAR-T candidate BNT211 Preparation for launch of Omicron XBB.1.5-adapted monovalent COVID-19... Read More

Acquisition aims to strengthen BioNTech’s pioneering position in the field of AI-powered drug discovery, design and development InstaDeep to operate as London based subsidiary of BioNTech and will be the centerpiece of its growing portfolio of initiatives around artificial intelligence and machine learning Approximately 290 highly skilled professionals and a global network of research partners in the fields of artificial... Read More

MAINZ, Germany, July 24, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the second quarter 2023 on Monday, August 7 th , 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update... Read More

Initiation of pivotal Phase 3 trial in non-small cell lung cancer (NSCLC) marks the first landmark in BioNTech’s and OncoC4’s strategic collaboration initiated in March 2023 with the aim to evaluate BNT316/ONC-392 in various solid tumor indications The randomized Phase 3 trial is expected to enroll approximately 600 patients with metastatic, immunotherapy-resistant NSCLC at clinical trial sites initially in the United... Read More

BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC) Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a... Read More

COVID-19 vaccine franchise focused on vaccine adaptation readiness ahead of the fall season and advancing next generation vaccine candidates and combinations BioNTech and partner OncoC4 plan to start a Phase 3 clinical trial evaluating anti-CTLA-4 antibody BNT316 (ONC-392) as monotherapy in NSCLC patients who progress after PD-1/PD-L1 treatment Added new class of precision therapeutics to clinical-stage oncology portfolio,... Read More

MAINZ, Germany, April 24, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2023 on Monday, May 8 th , 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for... Read More

BioNTech receives exclusive licenses from DualityBio for two investigational antibody-drug conjugate assets (DB-1303 and DB-1311) directed against targets expressed in a broad range of human cancers Collaboration will add a new class of precision medicine therapeutics to BioNTech’s clinical-stage oncology portfolio, expanding the breadth of its immunotherapy toolkit with synergistic potential DualityBio receives upfront... Read More

MAINZ, Germany, March 28, 2023 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) today announced that it has entered into a new share repurchase program (the “Program”), pursuant to which the Company may purchase American Depositary Shares, each representing one ordinary share (“ADS”), of the Company in the amount of up to $0.5 billion during the remainder of 2023. BioNTech expects to use all or a... Read More

Expanded and advanced oncology pipeline to 20 programs in 24 ongoing clinical trials including five ongoing randomized Phase 2 clinical trials; multiple trials with registrational potential expected to be initiated in 2023 and 2024 Announced licensing agreement with OncoC4 to complement the Company’s oncology portfolio with clinical stage next-generation immune checkpoint modulator; a randomized Phase 3 trial planned to... Read More

BioNTech to receive exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 monoclonal antibody candidate, ONC-392 BioNTech and OncoC4 will co-develop ONC-392 as monotherapy or in combination with anti-PD1 in various solid tumor indications, with a randomized Phase 3 trial planned to start in 2023 BioNTech also plans to combine ONC-392 with its proprietary oncology product candidates to evaluate... Read More

MAINZ, Germany, March 13, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the full year and fourth quarter 2022 on Monday, March 27 th , 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a... Read More

JERUSALEM, Israel, March 1, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the Company”) announced that the Company and the Weizmann Institute of Science (“Weizmann Institute”) signed a Memorandum of Understanding (MoU). As part of this MoU, scientists from a variety of disciplines from BioNTech and the Weizmann Institute will collaborate in basic and applied research with the aim to better understand various diseases,... Read More

Plasmids are an important starting material for the manufacturing of mRNA- and cell-based drugs The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing an important starting material for its oncology and COVID-19 vaccine pipeline The investment of approximately €40 million is part of a long-term development plan for BioNTech’s manufacturing site in Marburg German... Read More

Acquisition to enable creation of a fully integrated, enterprise-wide capability to discover, design and develop next-generation immunotherapies at scale by leveraging artificial intelligence and machine learning technologies across BioNTech’s therapeutic platforms and operations Builds on multi-year strategic collaboration between BioNTech and InstaDeep which included the formation of an AI Innovation Lab in 2020 and... Read More

Multi-year collaboration focuses on three strategic pillars: cancer immunotherapies, infectious disease vaccines, and expansion of BioNTech’s footprint in the UK BioNTech aims to design and roll out randomized clinical trials with registrational potential for the Company’s personalized mRNA cancer immunotherapies in the UK Accelerated clinical trial recruitment with first patient to be enrolled in a trial as part of this... Read More

Mainz, Germany, December 28, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that CEO and Co-founder Prof. Ugur Sahin, M.D., will present a corporate overview and update at the 41 st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 9:45 am PST / 12:45 pm ET. A live webcast of the presentation will be available via the “Events & Presentations” page in... Read More

BioNTech aims to develop the first mRNA-based vaccine for Malaria prevention based on a novel multi-antigen vaccine approach First evaluated candidate BNT165b1 expresses certain parts of the circumsporozoite protein (CSP) BNT165 program will assess other vaccine targets to identify the multi-antigen vaccine candidate that will proceed into planned later-stage clinical development MAINZ, Germany, December 23, 2022 – BioNTech... Read More

Approximately 11,500 of the companies’ mRNA-based COVID-19 vaccine doses arrived on the Chinese Mainland to enable vaccination campaign for German expatriates Vaccines expected to be available in Beijing, Shanghai, Guangzhou, Shenyang and Chengdu MAINZ, GERMANY, and SHANGHAI, CHINA, December 22, 2022 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd.... Read More

MAINZ, GERMANY, December 21, 2022 — BioNTech SE (Nasdaq: BNTX, “BioNTech”) reached the next milestone in the establishment of scalable mRNA vaccine production in Africa. The six ISO-sized shipping containers for the first BioNTainer have finished construction in Europe, underwent quality checks by BioNTech experts and are being prepared for shipment to Kigali, Rwanda, where they are expected to arrive in the first quarter of... Read More

First-in-human study aims to evaluate the safety and immunogenicity of prophylactic herpes virus vaccine candidate BNT163 BNT163 is the first candidate from BioNTech’s infectious disease mRNA vaccine collaboration with the University of Pennsylvania to enter the clinic The program is part of BioNTech’s strategy to address diseases with high unmet medical need, as no vaccine has been approved for prevention of genital lesions... Read More

COMIRNATY Original & Omicron BA.4/BA.5 now authorized in Canada as a booster dose for children 5 through <12 years old Authorization is based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines as well as data from the companies' original COVID-19 vaccine Health Canada's authorization is for a 10-µg booster dose of COMIRNATY Original & Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in... Read More

NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Fast Track is a process designed to facilitate the... Read More

Bivalent vaccine authorized as third 3-µg dose in the three-dose primary series Consistent COVID-19 hospitalization rates in this age group coupled with an overall surge in respiratory illnesses among children under 5 in the United States creates urgent need to make updated COVID-19 vaccines available Doses to ship immediately upon recommendation by CDC NEW YORK and MAINZ, GERMANY, DECEMBER 8, 2022 — Pfizer Inc. (NYSE: PFE)... Read More

The companies enter a multi-target research collaboration to develop multiple small molecule programs targeting immune modulation in cancer and potentially other disease areas based on targets selected by BioNTech In addition to these programs, BioNTech will receive a global, exclusive license to develop and commercialize Ryvu’s STING agonist portfolio as standalone small molecules Ryvu will receive €40 million from... Read More

NEW YORK and MAINZ, GERMANY, NOVEMBER 16, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a Phase 1 study to evaluate the safety, tolerability and immunogenicity of a next generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T cell responses and potentially broaden protection against COVID-19. This candidate, BNT162b4, is composed of a T cell... Read More

First mRNA manufacturing facility in Singapore will create regional manufacturing capacities in support of BioNTech’s growing pipeline of mRNA-based vaccines and therapeutics across Asia Pacific region for both clinical and commercial scale State-of-the art facility is expected to be fully operational in late 2023, and to create more than 100 jobs Acquisition marks the next step in BioNTech’s plans to establish a regional... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter 2022 on Monday, November 7 th , 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the third quarter 2022. To access the live... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization (MA) for a 3-µg dose of COMIRNATY ® (COVID-19 vaccine, mRNA), which is based on the wild-type spike protein of SARS-CoV-2, as a three-dose series for children ages 6 months to less than 5 years (also referred to as 6... Read More

Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels Data suggest Omicron BA.4/BA.5-adapted bivalent booster is anticipated to provide better protection against Omicron BA.4/BA.5 sublineages than original vaccine across... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-µg doses will be shipped immediately. “As families... Read More

BioNTech and Australia’s State of Victoria will establish an mRNA research and innovation center to strengthen translational research for innovative medicines from discovery to delivery As part of the partnership, BioNTech is committed to building a BioNTainer ® facility for end-to-end clinical scale manufacturing of mRNA-based products and candidates in Melbourne BioNTech plans to further expand its clinical development... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine... Read More

Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY ® Original/Omicron BA.4-5 and COMIRNATY ® Original/Omicron BA.1 bivalent vaccines CHMP separately recommends approval of booster dose of COMIRNATY ® in children 5 through 11 years of age in the European Union Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the... Read More

CHMP recommendation based on favorable data from Omicron-adapted vaccines The Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine combines 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the original Pfizer-BioNTech COVID-19 vaccine and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants Pfizer-BioNTech bivalent Omicron BA.4/BA.5 COVID-19 vaccine is available to ship immediately,... Read More

Follow-up data further demonstrate encouraging signs of clinical anti-tumor activity and a manageable safety and tolerability profile, building on the positive interim data presented at AACR in April Strongest responses seen in testicular cancer patients treated at dose level 2 after lymphodepletion with overall response rate of 57% and a disease control rate of 85%; product candidate recently received Priority Medicines... Read More

BioNTech SE (Nasdaq: BNTX) announced today that Prof. Ugur Sahin, CEO and Co-founder of BioNTech, visited Israel to meet with the Minister of Economy and Industry, Major General (res.) Orna Barbivay, the Accountant General, Mr. Yali Rothenberg, and other government officials. The visit was set to promote the potential cooperation between the State of Israel, its academic institutions and BioNTech on pandemic preparedness and... Read More

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine The Omicron BA.1-adapted bivalent COVID-19 vaccine combines 15 µg of mRNA encoding the SARS-CoV-2 wild-type spike protein which also in the Original Pfizer-BioNTech COVID-19 Vaccine with 15 µg of mRNA encoding the spike protein of the Omicron BA.1 variant Omicron BA.1-adapted bivalent... Read More

Authorization based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines Pfizer-BioNTech Omicron BA.4/BA.5 bivalent vaccine combines 15-µg of mRNA encoding the wild-type spike protein found in the original Pfizer-BioNTech COVID-19 bivalent vaccine and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants Pfizer-BioNTech Omicron BA.4/BA.5 COVID-19 bivalent vaccine... Read More

Submission follows application for Omicron BA.1-adapted bivalent vaccine submitted in July If authorized, both Omicron BA.1-adapted and Omicron BA.4/5-adapted bivalent vaccines will be available in the European Union as early as September Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron... Read More

Updated analysis from 34 cases occurring at least seven days following a three-dose regimen showed 73.2% vaccine efficacy among children ages 6 months through 4 years The vaccine efficacy remained consistently above 70% in both the 6 through 23 months and the 2 through 4 years age groups Sequencing of observed COVID-19 cases confirmed majority were caused by Omicron BA.2, broadening the evidence for efficacy across COVID-19... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron... Read More

Second quarter revenues of €3.2 billion 1 , net profit of €1.7 billion and fully diluted earnings per share of €6.45 ($6.87 2 ) as well as first half 2022 revenues of €9.6 billion, net profit of €5.4 billion and fully diluted earnings per share of €20.69 ($18.92 2 ) Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billion Preparing for potential launch of two variant-adapted bivalent COVID-19... Read More

Collaboration expands to include development of monospecific antibody candidates to address malignant solid tumors Expanded collaboration leverages Genmab’s proprietary HexaBody ® technology platform to develop novel immunotherapies First monospecific antibody candidate GEN1053/BNT313 planned to enter clinical trials by the end of 2022 BioNTech and Genmab will share costs and potential future profits on a 50:50 basis... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the second quarter 2022 on Monday, August 8 th , 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter 2022. To access the live... Read More

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg).... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2/3 trial found that a booster... Read More

First BioNTech product candidate to receive priority medicines (PRIME) designation by the European Medicines Agency for enhanced regulatory support facilitating the clinical development of the investigational cell therapy candidate BNT211 in the third- or later-line setting in patients with heavily pretreated testicular cancer Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety... Read More

Breaking of Ground for BioNTech’s initial African modular mRNA manufacturing facility in Kigali, Rwanda; delivery of first container modules planned for end of 2022 On invitation by H.E. President Paul Kagame of Rwanda, Heads of State and Government from Africa and around the world, highest leadership of African Union, European Union as well as from WHO and WTO joined BioNTech CEO Ugur Sahin on site to mark the establishment... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech” or the "Company”) will host the first edition of the Company’s Innovation Series on Wednesday, June 29 th , 2022. The virtual event will provide an update on BioNTech’s clinical progress across its pipeline and provide a deep-dive on scientific and technology innovation from its proprietary research engine. Investors and the interested public are invited to join a webcast with investment... Read More

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. for all individuals 6 months of age and older Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech”) will welcome its African partners for the first time on the African continent and provide an update on the joint establishment of mRNA manufacturing facilities and vaccine development plans. The event will encompass the groundbreaking for BioNTech’s initial African mRNA manufacturing facility in Kigali, Rwanda, where the first BioNTainer modules are planned to be delivered by the end of... Read More

Preliminary analysis of data from an ongoing investigator-initiated, single-center Phase 1 study supported by BioNTech and Genentech and conducted at Memorial Sloan Kettering Cancer Center, New York, United States Autogene Cevumeran, a fully individualized mRNA cancer immunotherapy (iNeST) demonstrated that vaccine-induced immunity significantly correlates with delayed tumor recurrence in patients with resected pancreatic... Read More

Shareholders reappointed Helmut Jeggle as Chairman of the Supervisory Board Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl will complement the existing Supervisory Board to reflect company growth Shareholders followed the proposal of the Management Board and Supervisory Board and resolved to pay a special cash dividend of €2.00 per ordinary share At the Annual General Meeting (“AGM”) of BioNTech SE (Nasdaq: BNTX,... Read More

Based on topline data, three doses of the Pfizer-BioNTech COVID-19 Vaccine met all immunobridging criteria required for Emergency Use Authorization The third 3-µg dose was well-tolerated among 1,678 children under 5 years of age with a safety profile similar to placebo Vaccine efficacy of 80.3% was observed in descriptive analysis of three doses during a time when Omicron was the predominant variant The 3-µg dose level,... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose... Read More

First quarter revenues of €6.4 billion 1 , net income of €3.7 billion and fully diluted earnings per share of €14.24 ($15.97 2 ) Reiterates BioNTech COVID-19 2022 vaccine revenue guidance of €13 billion to €17 billion First-in-class CAR-T program targeting CLDN-6 (BNT211) in solid tumors showed manageable safety profile and signs of clinical activity; preliminary Phase 1/2 data presented at AACR Annual Meeting 2022 Continued... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2022 on Monday, May 9 th , 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter 2022. The slide presentation and... Read More

Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine In the Phase 2/3 clincal trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by 6-fold against the SARS-CoV-2... Read More

Exclusive collaboration combines BioNTech’s mRNA vaccine development expertise and Matinas’ Lipid Nanocrystal (LNC) Delivery Platform Technology to advance novel formulations for mRNA vaccines, including a potential formulation for oral vaccines Matinas will receive an upfront exclusive access fee from BioNTech, as well as additional research funding BioNTech and Matinas have commenced license agreement discussions for... Read More

BNT211 combines two innovative approaches in one regimen, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve persistence and functionality of the adoptively transferred cells Treatment with BNT211 alone or in combination with CARVac, currently being tested in a Phase 1/2 Trial in patients with advanced solid tumors, was... Read More

BioNTech SE (Nasdaq: BNTX) today announced that it is one of the companies in Germany to be granted a pandemic preparedness contract by the Federal Republic of Germany. The framework agreement is aimed at pandemic preparedness including manufacturing and supply of mRNA vaccines in emergency situations in Germany. “There is growing evidence that viral pandemics will continue to pose a public health challenge for years. This... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) today announced that it has entered into a share repurchase program (the “Program”), pursuant to which the Company may purchase American depositary shares (ADSs) in the amount of up to $1.5 billion over the next two years. BioNTech expects to use all or a portion of the ADSs to satisfy upcoming settlement obligations under the Company’s share-based payment arrangements.... Read More

Fourth quarter and full year revenues of €5.5 billion 1 and €19.0 billion 1 , respectively Full year net income of €10.3 billion and fully diluted earnings per share of €39.63 ($46.87 2 ) Expect to authorize a share repurchase program of up to $1.5 billion over the next two years and will propose a special cash dividend of €2.00 per share, pending approval at the Annual General Meeting Approximately 2.6 billion doses of... Read More

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. The FDA also has authorized a second booster dose for individuals 12 years of age and older who have... Read More

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the full year and fourth quarter 2021 on Wednesday, March 30 th , 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full... Read More

Submission based on real-world safety and efficacy data from Israel Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have... Read More

BioNTech and Regeneron plan to jointly conduct clinical trial s evaluating FixVac candidate BNT116 in combination with Libtayo for the treatment of advanced non-small cell lung cancer (NSCLC) The d evelopment costs for the trials will be equally shared between the parties The companies advance clinical development of FixVac and Libtayo combination to third tumor type build ing on their existing agreements in melanoma and... Read More