BioNTech SE

BioNTech SE engages in the development of novel medicines at the intersection of immunology and synthetic biology. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Ozlem Tureci and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

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BioNTech reports robust 2022 earnings, eyes growth in oncology and infectious diseases

BioNTech's strong financial performance in 2022 sets the stage for continued growth in 2023, with a focus on expanding its vaccine portfolio, advancing oncology programs, and navigating the evolving landscape of COVID-19. The company's strategic priorities align with market demands for infectious disease and oncology solutions, positioning BioNTech for future success and profitability.

BioNTech posts robust Q1 results, eyes growth in vaccines and oncology

BioNTech's Q1 2023 performance reflects strong financial results and promising developments in its vaccine and oncology programs.
While facing challenges such as seasonal trends and data constraints, the company is strategically positioned to leverage opportunities in commercial planning and therapeutic advancements.
With a focus on synergistic partnerships and innovative technologies, BioNTech aims to maintain its competitive edge in the biopharmaceutical industry.
The company's commitment to enhancing existing platforms and exploring new growth avenues underscores its resilience and adaptability in a dynamic market environment.

BioNTech reports mixed Q2 results, focuses on innovation and growth

BioNTech's Q2 2023 performance reflects a mix of strong revenue generation and financial challenges, emphasizing the importance of strategic focus.
The company's strengths lie in its innovative collaborations, pipeline advancements, and preparedness for market demands, despite facing financial losses.
Navigating challenges in financial sustainability, market competition, and stakeholder communication will be crucial for BioNTech's future growth and success.

BioNTech adjusts revenue guidance amidst vaccine demand challenges

BioNTech's Q3 2023 performance reflected revenue challenges from lower COVID-19 vaccine demand and write-downs, prompting revised revenue guidance.
Despite challenges, the company showcased strengths in vaccine development, oncology advancements, and strategic cost management initiatives.
Opportunities lie in shared R&D expenses, long-term growth prospects from combination vaccines, and maintaining financial strength during market transition.

BioNTech reports strong Q4 earnings, eyes diversified product expansion

BioNTech is strategically investing in expanding its product portfolio while navigating uncertainties in COVID-19 vaccine revenues. The company aims to transform into a multiproduct company by 2030, focusing on oncology and infectious diseases.

BioNTech advances oncology pipeline, eyes growth amid financial challenges

BioNTech is making significant strides in its oncology pipeline, aiming for multiple product launches by 2026 and focusing on cancer vaccines and mRNA treatments.
While facing financial losses and short-term profitability challenges, the company remains optimistic about its growth trajectory and revenue potential.
Strategic investments in technology platforms, commercial readiness, and partnerships position BioNTech for sustainable growth and value enhancement.
Balancing cost control, revenue generation, and clinical execution will be crucial for BioNTech to capitalize on opportunities and navigate challenges effectively.

BioNTech reports Q2 progress in oncology pipeline amid financial challenges

BioNTech's Q2 2024 earnings call highlighted progress in oncology and COVID-19 vaccines, with total revenues of EUR 129 million but a net loss of EUR 808 million. The company remains focused on advancing innovative therapies and expanding its global manufacturing capabilities.

BioNTech reports robust Q3 earnings, focuses on oncology pipeline

BioNTech's Q3 2024 performance was strong, driven by COVID-19 vaccines and oncology trials.
While facing revenue challenges in certain regions, the company remains focused on growth.
Opportunities lie in advancing oncology pipeline and demonstrating product potential.
Maintaining a strong cash position provides flexibility for future investments.

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BioNTech SE operates as immunotherapy company, which engages therapies for cancer and other serious diseases. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Oezlem Tuereci, and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

Moderna

Pfizer

Shots are expected to start going in arms next week.

CDC Panel Recommends Covid Vaccines For Young Children

The CDC committee voted unanimously to recommend the shots for use in infants through preschoolers after two days of meetings that were open to the public.

CDC advisors recommend Covid vaccines for children as young as 6 months

Pending the CDC's signoff, both Moderna and Pfizer shots could be available for the youngest children within days.

FDA Approves COVID Vaccines for Kids as Young as 6 Months Old

The vaccines will be available for young children once the CDC recommends them, which will likely happen this weekend.

FDA authorizes Pfizer and Moderna COVID-19 vaccines for children as young as 6 months old

The Food and Drug Administration announced Friday that it authorized the COVID-19 vaccines developed by BioNTech SE BNTX, -6.41% /Pfizer Inc. PFE, -2.12% and Moderna Inc. MRNA, -5.80% for children as young as six months old. The regulator said Moderna's two-dose vaccine is now authorized for children between the ages of 6 months old and 17 years old.

FDA authorizes both mRNA vaccines for young children

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, a

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

The White House expects vaccinations to begin as soon as Tuesday.

FDA authorizes Pfizer and Moderna's Covid vaccines for children as young as 6 months

The U.S. Food and Drug Administration has authorized user of the COVID-19 vaccines from Pfizer and BioNTech, and from Moderna, for kids between 6 months and 5 years of age. The FDA's decision follows a length review process, and the dosage for children under 5 is greatly reduced relative to those for older children and […]

FDA clears COVID-19 vaccines for children under 5

The approval comes just two days after an advisory panel recommended both Moderna and Pfizer vaccines for young children.

FDA Authorizes Covid Vaccines For Children As Young As 6 Months

BioNTech SE (NASDAQ:BNTX) is trading at $137.99. The 52-week range has been $121 to $464.

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Blame it on the overall stock market sell-off.

Why Pfizer, BioNTech, and Moderna Stocks Are Sinking Today

The FDA VRBPAC committee unanimously recommends the approval of both Pfizer and BioNTech and Moderna's vaccines for young children, saying the benefits of the vaccines outweigh the risks.

FDA Panel Recommends Pfizer & Moderna COVID Jabs for Young Kids

Per the FDA reviewers, the available data supports Pfizer (PFE) and BioNTech (BNTX) vaccine's effectiveness in preventing COVID infection in kids six months to under five years of age as a three-dose primary series.

Pfizer, BioNTech's COVID Jab Safe in Young Kids Per FDA

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COVID-19 vaccine maker BioNTech said construction of an mRNA vaccine factory to serve Africa would start on June 23 in Rwanda.

BioNTech to soon start mRNA vaccine factory construction in Rwanda

MAINZ, Germany, June 9, 2022 (GLOBE NEWSWIRE) —  BioNTech SE (Nasdaq: BNTX, “BioNTech”) will welcome its African partners for the first time on the African continent and provide an update on the joint establishment of mRNA manufacturing facilities and vaccine development plans. The event will encompass the groundbreaking for BioNTech's initial African mRNA manufacturing facility in Kigali, Rwanda, where the first BioNTainer modules are planned to be delivered by the end of 2022.

BioNTech to Provide an Update on Manufacturing and Development Plans of mRNA Vaccines in Africa

MAINZ, Germany and CHICAGO, June 5, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC). Feasibility of the process of profiling each patient's tumor to inform individualized vaccine design and on-demand manufacturing of iNeST in a clinically relevant timeframe was confirmed. The preliminary results showed a favorable safety profile as well as encouraging signs of clinical activity. The data have been presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting 2022 by Vinod Balachandran, M.D., at Memorial Sloan Kettering Cancer Center. Autogene cevumeran is the lead candidate from BioNTech's iNeST platform, which is jointly developed together with Genentech, a member of the Roche Group, in multiple solid tumor indications.

Positive Phase 1 Data from mRNA-based Individualized Neoantigen Specific Immunotherapy in Patients with Resected Pancreatic Cancer presented at ASCO

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MAINZ, GERMANY, June 1, 2022 (GLOBE NEWSWIRE) — At the Annual General Meeting (“AGM”) of BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) held today, June 1, 2022, shareholders voted to reappoint Helmut Jeggle as a member of the Supervisory Board with a majority of 96.44 per cent. In a meeting following the AGM, the Supervisory Board re-elected Helmut Jeggle as its Chairman. Shareholders also appointed two additional Supervisory Board members, Prof. Dr. Anja Morawietz and Prof. Dr. Rudolf Staudigl with a majority of 99.85 per cent and 99.86 per cent respectively. All three members will serve in their roles until the AGM 2026.

Voting Results from BioNTech's Annual General Meeting 2022

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Pfizer (PFE) and BioNTech (BNTX) state that their three-dose COVID-19 vaccine is 80% effective in children under five years of age.

Pfizer & BioNTech COVID Jab Booster Effective in Kids Under 5

Pfizer Inc (NYSE:PFE) and BioNTech SE say their three-dose Covid-19 vaccine for children ages 6 months to 5 years old was 80% effective at preventing illness during the surge of the Omicron variant. According to clinical trial results released Monday, a third vaccine dose was well tolerated by the children, and most side effects were mild to moderate.

Pfizer/BioNTech say third vaccine dose is 80% effective against Omicron in kids 5 and younger

Shares of Pfizer Inc. PFE, +3.59% rose 0.3% and BioNTech SE BNTX, -2.90% rallied 1.3% in premarket trading, after the drug makers said three doses of it COVID-19 vaccine for children aged six months to five years "met all immunobridging criteria" required for Emergency Use Authorization by the U.S. Food and Drug Administration. The companies said the vaccine showed 80.3% efficacy in an analysis of three doses at a time when omicron was the dominant variant, with a favorable safety profile, similar to placebo.

Pfizer, BioNTech COVID-19 vaccine for children aged 6 months to 5 years meets EUA criteria

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Vaccine efficacy, a secondary endpoin

Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose

An overall market rebound and Tuesday's authorization of boosters for kids likely propelled the stock higher.

News for BioNTech SE Stock (BNTX)