BIONTECH Stock Price, News & Analysis

BioNTech has begun construction of its first mRNA manufacturing facility in Kigali, Rwanda, with the aim of establishing a decentralized vaccine production network in Africa. The facility, which will employ around 100 staff by 2024, is set to receive its first BioNTainers by the end of 2022. This site aims to support local vaccine production for African Union members, including potential malaria and tuberculosis vaccines. The project aligns with BioNTech’s commitment to climate neutrality, utilizing renewable energy sources for operations.

BioNTech will host its first Innovation Series virtual event on June 29, 2022, at 8:00 a.m. EDT. This event aims to offer insights into the company's clinical advancements and technological innovations. Investors and the public can register for a listen-only webcast. Attendees can access the presentation and audio via a provided link, with the platform opening ten minutes before the event. A replay will be accessible for 30 days post-event. BioNTech specializes in pioneering therapies for cancer and infectious diseases, leveraging mRNA technology and global collaborations.

Pfizer Inc. and BioNTech SE have received FDA emergency use authorization for their COVID-19 vaccine, now available for children aged 6 months to 4 years. The 3-µg dose showed a strong immune response and a favorable safety profile similar to the placebo in a Phase 2/3 clinical trial involving 4,526 children. The trial demonstrated immunogenicity comparable to older age groups, meeting regulatory non-inferiority criteria. The vaccine rollout is anticipated to begin following CDC recommendations, ensuring free access for U.S. residents.

The FDA has granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine as a 3-µg dose series for children aged 6 months to 4 years. This decision follows a Phase 2/3 clinical trial involving 4,526 children, which demonstrated a strong immune response and a safety profile comparable to a placebo. The vaccine elicited SARS-CoV-2-neutralizing antibody GMTs of 1,535.2 for children aged 2-4 years and 1,406.5 for infants 6-23 months. Vaccinations for this age group are expected to commence following CDC recommendations.

BioNTech will host its African partners in Kigali, Rwanda on June 23, 2022, to mark the groundbreaking of its first mRNA manufacturing facility.

With the delivery of BioNTainer modules expected by the end of 2022, BioNTech plans to enhance vaccine production capabilities on the continent.

High-level attendees include heads of state and representatives from the African Union, European Union, and WHO, showcasing international collaboration in vaccine development.

BioNTech (BNTX) announced preliminary data from a Phase 1 study at Memorial Sloan Kettering Cancer Center, revealing that autogene cevumeran, an individualized mRNA cancer therapy, correlates with delayed tumor recurrence in pancreatic ductal adenocarcinoma (PDAC). The combination with atezolizumab showed a favorable safety profile, with only one patient experiencing severe side effects. The trial revealed a significant improvement in recurrence-free survival for patients with vaccine-induced immune responses. A randomized study is planned for further evaluation of autogene cevumeran in PDAC treatment.

BioNTech SE held its Annual General Meeting on June 1, 2022, where shareholders reappointed Helmut Jeggle as Chairman of the Supervisory Board with 96.44% support. Additionally, Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl were added to the board. The company announced a special cash dividend of €2.00 per share, totaling approximately €484.2 million. The meeting highlighted BioNTech's commitment to shareholder value and plans for substantial investment in R&D, expecting to allocate €1.4 to €1.5 billion in 2022.

Pfizer and BioNTech have announced positive topline results from their Phase 2/3 trial of a 3-µg dose of their COVID-19 vaccine for children under 5. The vaccine met all immunobridging criteria for Emergency Use Authorization, showing an efficacy of 80.3% during Omicron prevalence. The 1,678 children in the trial exhibited a favorable safety profile similar to placebo, with no new safety signals identified. Regulatory submissions to the FDA and other agencies are expected to follow this week.

Pfizer and BioNTech announced that their COVID-19 vaccine, with a third 3-µg dose for children under 5, met all immunobridging criteria for Emergency Use Authorization. A trial involving 1,678 children showed a favorable safety profile similar to placebo, with vaccine efficacy of 80.3% against symptomatic COVID-19 during the Omicron variant's surge. The companies plan to submit updated data to the FDA and other global regulators soon. The trial aims to provide strong protection against COVID-19 in young children, building on previous successful adult and adolescent studies.