BIONTECH - BNTX STOCK NEWS

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.

Pfizer and BioNTech announced a proposed agreement with the European Commission for a supply of 200 million doses of their BNT162 mRNA-based COVID-19 vaccine, with an option for an additional 100 million doses. Deliveries are set to start by the end of 2020, pending regulatory approval. This agreement represents the largest initial order for the companies. The vaccine will be produced at BioNTech's German sites and Pfizer's Belgium site. Pfizer plans to seek regulatory review for BNT162b2 as early as October 2020, aiming for up to 100 million doses by the end of 2020 and 1.3 billion by end of 2021.

The CEOs of nine major biopharmaceutical companies, including BioNTech SE (BNTX), have united to pledge prioritizing the safety and well-being of vaccinated individuals in the development of COVID-19 vaccines. This historic commitment emphasizes adherence to high ethical standards and sound scientific principles throughout vaccine trials. They assure that regulatory processes will involve large, randomized clinical trials with diverse participants. The companies aim to bolster public confidence in the vaccine approval process, showcasing their extensive experience in developing vaccines to address global health threats.

Pfizer and BioNTech have released Phase 1 data for the BNT162b2 vaccine targeting SARS-CoV-2, showing strong immunogenicity. After the second dose, younger adults had neutralizing geometric mean titers (GMTs) 3.8 times higher than convalescent sera, while older adults had GMTs 1.6 times higher. The vaccine was well tolerated, with mild to moderate fever in under 20% of participants. Over 11,000 participants are enrolled in ongoing trials, with regulatory review anticipated by October 2020. If approved, they plan to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.

BioNTech SE (Nasdaq: BNTX) announced key advancements in its clinical pipeline, reporting a successful initiation of the pivotal Phase 2b/3 trial for the BNT162 COVID-19 vaccine. Initial commercial supply agreements have been signed for over 250 million doses with several countries. The company ended Q2 2020 with cash and equivalents totaling €573 million, raising an additional €681 million from recent offerings. However, a net loss of €88.3 million was recorded for Q2, reflecting increased research and development expenditures. Financial guidance indicates expected cash usage between €450 million and €600 million for 2020.

BioNTech (BNTX) will announce its Q2 2020 financial results on August 11, 2020, followed by a conference call at 08:00 a.m. EDT. Investors can access a webcast of the event and see a slide presentation. The company focuses on immunotherapy, developing innovative treatments for cancer and infectious diseases using mRNA technology. BioNTech collaborates with several major pharmaceutical companies, including Pfizer and Sanofi, to advance its diverse pipeline of therapies and vaccines.

BioNTech (BNTX) and Fosun Pharma announce the initiation of a Phase 1 clinical trial for the COVID-19 vaccine candidate BNT162b1 in China, enrolling 144 participants aged 18-55 and over 55. The trial, approved by the NMPA, aims to evaluate safety and immunogenicity, with participants receiving two doses of either 10µg or 30µg of the vaccine or placebo. The study builds on prior trials in Germany and the U.S. and could support regulatory approval in China. If successful, Fosun Pharma will exclusively commercialize the vaccine in mainland China.