BIONTECH - BNTX STOCK NEWS

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.

Pfizer and BioNTech announced a new agreement with the U.S. government to supply 105 million COVID-19 vaccine doses, expected to deliver between late summer and Q4 2022. The government will pay $3.2 billion upon receipt. Furthermore, there’s an option for an additional purchase of up to 195 million doses, totaling 300 million. This supply may include adult Omicron-adapted vaccines, pending FDA authorization. The agreement aims to enhance vaccine availability against current and future COVID-19 variants.

Pfizer and BioNTech have secured a new vaccine supply agreement with the U.S. government for 105 million doses of COVID-19 vaccines. The deal is worth $3.2 billion, with doses to be delivered by Q4 2022, potentially including Omicron-adapted vaccines pending FDA authorization. The agreement allows for an additional 195 million doses if required. This effort aims to ensure access to vaccines as COVID-19 variants evolve and will continue to provide free vaccinations to eligible U.S. residents.

Pfizer and BioNTech have announced promising results from Phase 2/3 trials of two Omicron-adapted COVID-19 vaccine candidates, both monovalent and bivalent. A booster dose of these vaccines showed significant increases in neutralizing geometric titers against the Omicron BA.1 variant, with 13.5 and 19.6-fold increases for the monovalent and 9.1 and 10.9-fold for the bivalent candidates at 30 µg and 60 µg doses, respectively. Both candidates demonstrated a favorable safety profile. Data is being shared with regulators for potential rapid introduction, targeting current and future COVID-19 variants.