BioNTech SE American Depositary Share - BNTX STOCK NEWS

BioNTech SE (Nasdaq: BNTX) reported significant progress in its COVID-19 vaccine candidate BNT162b2, demonstrating more than 90% efficacy in preventing COVID-19 in participants without prior SARS-CoV-2 infection during a Phase 3 trial. The trial enrolled 43,538 participants with no serious safety concerns. BioNTech plans to submit for Emergency Use Authorization (EUA) following the expected safety milestone in November. Financially, the company closed financings totaling approximately $1.2 billion, with a net cash receipt of $800 million in Q3 2020.

BioNTech (Nasdaq: BNTX) and Pfizer announced that their mRNA-based vaccine candidate BNT162b2 showed over 90% efficacy in preventing COVID-19 in participants without prior infection, as per the first interim analysis from their Phase 3 trial. This analysis evaluated 94 confirmed cases among 43,538 enrolled participants, with 42% from diverse backgrounds. No serious safety issues were reported. The companies plan to submit for Emergency Use Authorization (EUA) to the FDA following the safety milestone expected in late November, as they continue trials to gather further efficacy data.

BioNTech SE (Nasdaq: BNTX) will announce its third quarter 2020 financial results on November 10, 2020. A conference call and webcast for investors and analysts will be held at 08:00 a.m. EDT (2:00 p.m. CET) on the same day. Participants can access the call via specific phone numbers provided in the announcement or through the Investor Relations section of BioNTech's website. BioNTech is a biopharmaceutical company focused on developing innovative therapies for serious diseases, including cancer, utilizing advanced mRNA technology.

BioNTech (Nasdaq: BNTX) announced that results from three studies have been accepted for presentation at the SITC 35th Annual Meeting. This includes preliminary data from the first-in-human trial of intratumoral immunotherapy BNT131 (SAR441000) in collaboration with Sanofi, along with Phase 1/2 data for DuoBody®-PD-L1x4-1BB (BNT311/GEN1046) developed with Genmab. Presentations will occur from November 11-14, 2020. Abstracts will be available on the SITC website on November 9, 2020.

BioNTech (BNTX) and Pfizer announced the initiation of a rolling submission to the European Medicines Agency (EMA) for their COVID-19 vaccine candidate BNT162b2. The EMA's decision is based on promising early clinical data showing the vaccine's ability to generate neutralizing antibodies and T cell responses. This rolling review allows for the evaluation of data as it becomes available, facilitating a potential marketing authorization application. The global Phase 3 study has enrolled about 37,000 participants, with findings indicating good tolerability and immunogenicity.

BioNTech announced the acquisition of a GMP-certified manufacturing facility in Marburg, Germany, from Novartis to boost COVID-19 vaccine production capacity by up to 750 million doses annually. The facility, expected to become operational in 2021, employs around 300 staff and will facilitate the production of the mRNA vaccine candidate BNT162b2. This strategically located site enhances BioNTech's manufacturing capabilities and the company's plans include leveraging the facility for additional product lines, contributing to a diversified cancer and infectious disease pipeline.

BioNTech announced a grant of up to 375 million Euro from the German Federal Ministry of Education and Research (BMBF) to support its BNT162 COVID-19 vaccine program. The funding will help scale up manufacturing and accelerate development. BioNTech has achieved five out of eight defined milestones, with over 28,000 participants enrolled in the Phase 3 clinical trial across the U.S., Brazil, Argentina, and Europe. The BMBF initiative aims to enhance vaccine capabilities in Germany, contributing to the global fight against COVID-19.

BioNTech SE (NASDAQ: BNTX) and Pfizer (NYSE: PFE) announced an amendment to their Phase 3 COVID-19 vaccine trial protocol, increasing participant enrollment to approximately 44,000. The trial, aimed at diversifying the participant population, will now include adolescents aged 16 and older and patients with chronic HIV, Hepatitis C, or Hepatitis B. Enrollment is on track to meet the initial target of 30,000 participants by next week. The companies anticipate a conclusive efficacy readout by the end of October.

BioNTech (BNTX) and Pfizer report promising preclinical data for their mRNA vaccine candidate BNT162b2 against SARS-CoV-2. Immunization of rhesus macaques showed 100% prevention of lung infection and viral clearance in the nasal cavity within 3 days post-infection. The vaccine elicited strong neutralizing antibody responses and TH1-biased T cell responses. Currently, BNT162b2 is advancing into Phase 2/3 trials with over 25,000 participants. If successful, they aim to provide up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021, pending regulatory approvals.