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BioNTech SE (BNTX) is a global biotechnology pioneer advancing mRNA-based therapies for cancer and infectious diseases. This page provides investors and stakeholders with timely updates on corporate developments, clinical research milestones, and strategic initiatives shaping the future of personalized medicine.
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Bookmark this page for streamlined access to BioNTech's evolving role in oncology therapeutics and next-generation vaccine development. Regularly updated to reflect the company's scientific advancements and business strategy execution.
Pfizer and BioNTech announced the submission of a booster dose application for an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine to the European Medicines Agency (EMA). This submission follows their earlier application for the Omicron BA.1-adapted vaccine. The booster targets individuals 12 years and older, generating a strong neutralizing antibody response per pre-clinical data. Regulatory approvals are expected shortly, with availability as early as September, pending authorization. The companies also submitted a request for Emergency Use Authorization to the FDA on August 22.
Pfizer and BioNTech have submitted an application to the European Medicines Agency for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12 and older. This follows the earlier submission for an Omicron BA.1-adapted vaccine in July. If authorized, both vaccines could be available in the EU as early as September. The bivalent vaccine aims to enhance neutralizing antibody responses against multiple variants, including the original strain and Omicron subvariants.
Pfizer and BioNTech announced that their COVID-19 vaccine shows 73.2% efficacy for children aged 6 months to 4 years following a three-dose regimen. Efficacy remained above 70% across younger age groups. The trial involved over 10,000 children and confirmed the vaccine's effectiveness against the Omicron BA.2 variant. The FDA granted Emergency Use Authorization in June, and applications for further approvals are in process. The companies plan to submit new efficacy data soon and are also developing a bivalent vaccine targeting Omicron BA.4/BA.5.
Pfizer and BioNTech have updated the efficacy results of their COVID-19 vaccine for children aged 6 months to 4 years, reporting a vaccine efficacy of 73.2% based on 34 cases observed more than seven days post-vaccination. Efficacy was confirmed across variants, primarily Omicron BA.2, with favorable safety profiles. The data supports the ongoing review for Emergency Use Authorization by the FDA and a conditional Marketing Authorization by the EMA, alongside plans for an adapted vaccine targeting emerging Omicron strains.
Pfizer and BioNTech announced the submission for Emergency Use Authorization (EUA) of a 30-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12 and older. The application leverages existing data from their previous bivalent vaccine and aims to address circulating SARS-CoV-2 variants. Upon authorization, the companies are prepared to begin immediate distribution of the vaccine. A similar application is underway with the European Medicines Agency (EMA) as they seek to enhance public health ahead of potential COVID-19 surges.
Pfizer and BioNTech announced their submission to the FDA for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12 and older. The companies have rapidly scaled production and are prepared to begin shipping doses immediately upon authorization. A similar application has been submitted to the European Medicines Agency. The bivalent vaccine is designed to generate a robust immune response against multiple variants, with pre-clinical data showing strong neutralizing antibody responses against Omicron variants and the original strain.
Genmab (NASDAQ: GMAB) and BioNTech (NASDAQ: BNTX) have expanded their collaboration to develop novel monospecific antibody candidates aimed at treating malignant solid tumors. The partnership will leverage Genmab's proprietary HexaBody technology, with the first candidate, GEN1053/BNT313, expected to enter clinical trials by the end of 2022. Both companies will share development costs and potential profits equally. This collaboration enhances their oncology pipeline, targeting high unmet medical needs in cancer immunotherapy.
BioNTech and Genmab have expanded their collaboration to develop novel monospecific antibody candidates aimed at malignant solid tumors. Utilizing Genmab's HexaBody technology, the partnership plans to share development costs and profits equally. The first candidate, GEN1053/BNT313, a CD27 antibody, is anticipated to enter clinical trials by the end of 2022. This expansion follows a history of collaboration on bispecific antibodies, enhancing BioNTech's oncology pipeline to address significant medical needs in cancer treatment.
Pfizer and BioNTech announced on July 27, 2022, the initiation of a Phase 2 clinical study for a new COVID-19 vaccine candidate, BNT162b5, designed to enhance immune responses against the SARS-CoV-2 virus, including the Omicron variant. The study aims to enroll around 200 participants aged 18-55 who have received a prior booster vaccine. This candidate is part of a broader strategy to develop robust, long-lasting vaccines. Both companies plan to seek regulatory approvals based on the study outcomes.
BioNTech (Nasdaq: BNTX) will announce its Q2 2022 financial results on August 8, 2022. The company invites investors to join a conference call and webcast at 8:00 a.m. EDT, where it will provide detailed financial insights and a corporate update. Participants can register for the call through a provided link and access presentation slides via the Investor Relations section of its website. A replay will be available for 30 days post-call. BioNTech focuses on pioneering immunotherapies for cancer and infectious diseases through advanced drug platforms.
