BioNTech SE American Depositary Share - BNTX STOCK NEWS

Pfizer and BioNTech announced significant findings from a Phase 2/3 clinical trial of the COVID-19 vaccine in children aged 5-11. Following a booster dose, the vaccine showed a 36-fold increase in neutralizing antibodies against the Omicron variant, alongside a 6-fold increase against the wild-type virus. The booster was well tolerated with no new safety concerns. The companies intend to submit these results for Emergency Use Authorization to the FDA and other global regulatory agencies soon, reinforcing their commitment to providing effective vaccinations for younger populations.

BioNTech (BNTX) has entered an exclusive collaboration with Matinas BioPharma to combine their expertise in mRNA vaccine development and Lipid Nanocrystal (LNC) Delivery Platform Technology. This partnership aims to advance innovative formulations for mRNA vaccines, including potential oral delivery options.

Matinas will receive an upfront access fee and additional research funding as part of the agreement. Discussions are underway for a formal license agreement for Matinas’ LNC platform technology.

BioNTech (BNTX) announced promising preliminary results from a Phase 1/2 trial of its CAR-T cell therapy, BNT211, targeting Claudin-6 in advanced solid tumors. The study involving 16 patients showed an disease control rate of 86% and an overall response rate of 43%. The treatment was well tolerated, with manageable adverse events like cytokine release syndrome. Notably, four testicular cancer patients achieved disease control. Further evaluations are planned, with the next data update expected later this year.

BioNTech SE announced the receipt of a pandemic preparedness contract from the German government, aimed at ensuring the supply of mRNA vaccines during emergencies. This agreement allows BioNTech to produce at least 80 million vaccine doses annually over an initial five-year term. Sean Marett, Chief Business Officer, emphasized the company's commitment to combating future pandemics and adapting vaccines to emerging variants. The contract reinforces BioNTech's role as a key player in pandemic response and showcases its ongoing investment in research and development.

BioNTech has initiated a $1.5 billion share repurchase program to enhance shareholder value, reflecting its strong 2021 performance. This program allows BioNTech to purchase American depositary shares (ADSs) over the next two years, primarily to meet obligations under share-based payment arrangements. CEO Jens Holstein emphasized the strategic nature of this initiative as part of the company's capital allocation strategy. The repurchase timing will depend on market conditions and will comply with SEC regulations.

BioNTech SE (BNTX) reported strong financial results for 2021, with revenues of €19.0 billion and a net income of €10.3 billion, translating to fully diluted earnings per share of €39.63. The company expects to authorize a share repurchase program of up to $1.5 billion and propose a special cash dividend of €2.00 per share. In 2022, BioNTech anticipates COVID-19 vaccine revenues of €13 billion to €17 billion, underpinned by signed orders for 2.4 billion doses. Additionally, the oncology pipeline has expanded to 16 clinical programs, reflecting BioNTech's commitment to R&D, with planned investments of €1.4 billion to €1.5 billion.

The FDA has expanded the emergency use authorization for Pfizer and BioNTech's COVID-19 vaccine, allowing a second booster dose for adults aged 50 and older who have had a first booster. This also includes individuals 12 years and older with certain immunocompromises. The additional dose is to be given at least four months after the first booster. Immunogenicity data show significant increases in antibody levels post-second booster, suggesting improved protection against COVID-19 variants, particularly for vulnerable populations. The same formulation as prior doses will be used.

BioNTech SE (Nasdaq: BNTX) is set to announce its financial results for the fourth quarter and full year 2021 on March 30, 2022. The company will host a conference call and webcast for investors and analysts at 8:00 a.m. EDT (2:00 p.m. CEST) to discuss these results and provide corporate updates. Participants can access the webcast via the company’s website, and a replay will be available for 30 days post-call. BioNTech is known for its innovative immunotherapy developments, particularly in mRNA vaccine technology.

Pfizer and BioNTech have submitted an application to the FDA for Emergency Use Authorization (EUA) of an additional booster dose of their COVID-19 vaccine for individuals aged 65 and older. This application is supported by real-world safety and efficacy data from Israel, showing a twofold reduction in confirmed infections and a fourfold reduction in severe illness for those receiving the additional booster compared to those who only received the initial booster. The data suggests that this booster significantly enhances immunogenicity and neutralizing antibodies against the Omicron variant.