Welcome to our dedicated page for BIONTECH news (Ticker: BNTX), a resource for investors and traders seeking the latest updates and insights on BIONTECH stock.
BioNTech SE (NASDAQ: BNTX) generates frequent news flow as a global next generation immunotherapy company focused on oncology, mRNA technologies and COVID-19 vaccines. Its updates often cover progress across a diversified oncology pipeline that includes mRNA cancer immunotherapies, next-generation immunomodulators, antibody-drug conjugates (ADCs) and chimeric antigen receptor (CAR) T cell therapies, as well as developments in its mRNA vaccine programs for infectious diseases.
Investors following BioNTech news can expect regular announcements on clinical trial milestones in major tumor types such as lung, breast, gynecologic, gastrointestinal and genitourinary cancers. Recent releases have highlighted late-stage data readouts and trial initiations for investigational agents like pumitamig (a PD-L1xVEGF-A bispecific antibody co-developed with Bristol Myers Squibb) and gotistobart (a CTLA-4–targeting Treg modulator), including Phase 2 and Phase 3 results in indications such as triple-negative breast cancer and squamous non-small cell lung cancer.
BioNTech’s news stream also includes corporate and financial updates, such as quarterly results, guidance changes, and details of its cash and investment position. The company reports on its COVID-19 vaccine franchise, including launches of variant-adapted vaccines for specific vaccination seasons, and comments on how vaccine market dynamics affect revenues.
Another recurring theme in BNTX news is strategic transactions and partnerships. BioNTech has announced an all-stock acquisition of CureVac N.V. to strengthen its position in mRNA design, delivery formulations and manufacturing, and regularly issues releases on its collaboration with partners including Bristol Myers Squibb, Duality Biologics, OncoC4, Pfizer and others.
This news page aggregates these developments in one place, allowing readers to track BioNTech’s clinical progress, partnership activity, financial disclosures and strategic updates over time.
Pfizer and BioNTech announced updated results from their Phase 3 study of the COVID-19 vaccine, BNT162b2, indicating a 91.3% efficacy against symptomatic COVID-19 up to six months post-second dose. The vaccine demonstrated 100% effectiveness in preventing severe disease per CDC guidelines and 95.3% effectiveness according to FDA standards. Over 44,000 participants were evaluated for safety, with favorable outcomes reported. The companies plan to submit a Biologics License Application to the FDA soon, bolstering confidence in the vaccine's ability to combat variants.
Pfizer and BioNTech released updated topline results from their pivotal Phase 3 study on the BNT162b2 COVID-19 vaccine, reporting a 91.3% efficacy rate in preventing symptomatic COVID-19. The vaccine showed 100% effectiveness against severe disease according to the CDC and 95.3% against severe COVID-19 per the FDA. Safety data indicated a favorable profile from over 12,000 participants monitored for at least six months post-vaccination. These results bolster plans for a Biologics License Application to the FDA.
BioNTech (Nasdaq: BNTX) and Pfizer released positive results from a Phase 3 trial showing BNT162b2 vaccine achieved 100% efficacy in adolescents aged 12-15, exceeding the results of the 16-25 age group. The trial involved 2,260 participants, with no COVID-19 cases in the vaccinated group. The companies plan to submit the data to the FDA and EMA for Emergency Use Authorization expansion. Additionally, they initiated a Phase 1/2/3 study for children aged 6 months to 11 years, aiming to assess vaccine safety and immunogenicity.
Pfizer (PFE) and BioNTech (BNTX) announced the successful results of a Phase 3 trial for their COVID-19 vaccine BNT162b2, showing 100% efficacy in adolescents aged 12 to 15. The trial, involving 2,260 participants, indicated no COVID-19 cases in the vaccinated group compared to 18 in the placebo group. The companies intend to submit these findings for Emergency Use Authorization (EUA) modification in the US and similar requests globally. They are also advancing studies in younger children, with the goal of public vaccination before the next school year.
BioNTech SE (Nasdaq: BNTX) has achieved significant milestones with its BNT162b2 COVID-19 vaccine, now approved in over 65 countries. As of March 23, 2021, over 200 million doses have been supplied, with orders totaling 1.4 billion doses for 2021. The company anticipates expanding production capacity to 2.5 billion doses by year-end. Financially, BioNTech reported COVID-19 vaccine revenues of €270.5 million for the full year 2020 and ended the period with €1.2 billion in cash. The oncology pipeline is advancing with 13 candidates in 14 ongoing trials.
BioNTech SE announced the European Medicines Agency (EMA) approved its COVID-19 vaccine manufacturing at the Marburg facility, enhancing production capabilities to one billion doses annually. Due to operational efficiencies, an increase of 250 million doses is expected. 400 employees are currently at Marburg, with the first drug product batches anticipated for delivery in April. The facility is GMP-certified, ensuring high-quality drug production standards. BioNTech aims to produce up to 250 million doses of BNT162b2 in early 2021, catering to the growing global demand.
BioNTech (Nasdaq: BNTX) and Pfizer announced EMA approval for their COMIRNATY vaccine to be stored at -25°C to -15°C for two weeks. This flexibility enhances distribution, allowing storage in pharmacies and supporting decentralized vaccinations at general practitioners' offices across the EU. The approval aims to increase accessibility and reduce pressure on large vaccination centers.
Ugur Sahin, BioNTech's CEO, emphasized the importance of this milestone, while Albert Bourla, Pfizer's CEO, noted the collaborative efforts with regulatory agencies to enhance vaccine distribution.
BioNTech (Nasdaq: BNTX) is set to announce its financial results for the fourth quarter of 2020 on March 30, 2021. An investor call and webcast will take place at 8:00 a.m. EDT (2:00 p.m. CET) to discuss the results and provide a corporate update. The event will be accessible via the company’s website. BioNTech specializes in immunotherapy for cancer and serious diseases, leveraging mRNA technology and collaborating with major pharmaceutical companies.
The Israel Ministry of Health, Pfizer, and BioNTech released data showing significantly lower COVID-19 incidences in fully vaccinated individuals with the Pfizer-BioNTech vaccine. Findings indicate vaccinated individuals were 44 times less likely to develop symptomatic COVID-19 and 29 times less likely to die. Vaccine effectiveness was measured at 97% against symptomatic cases and severe outcomes, and 94% against asymptomatic infections. This comprehensive evidence supports ongoing global vaccination efforts amidst the pandemic.
The Israel Ministry of Health, Pfizer, and BioNTech announced significant findings from a real-world study showing a 97% effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in preventing symptomatic COVID-19, severe cases, and deaths. This data, derived from health surveillance from January to March 2021, showcases the impact of Israel's vaccination efforts, particularly against the B.1.1.7 variant. Further, the vaccine demonstrated 94% effectiveness against asymptomatic infections, emphasizing its role in controlling the pandemic and supporting ongoing immunization campaigns globally.
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