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.

Mainz, Germany, October 24, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter 2022 on Monday, November 7th, 2022. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the third quarter 2022.

BioNTech to Report Third Quarter 2022 Financial Results and Operational Update on November 7, 2022

Moderna

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Novavax

Stocks were set to open lower today, but the market seems to have found its groove. Everything from tech stocks to vaccine stocks are moving higher.

Why Are Vaccine Stocks MRNA, PFE, BNTX, NVAX Up Today?

NEW YORK and MAINZ, Germany, October 19, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization (MA) for a 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA), which is based on the wild-type spike protein of SARS-CoV-2, as a three-dose series for children ages 6 months to less than 5 years (also referred to as 6 months through 4 years of age). The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

Anticipating a surge of COVID-19 infections later this year, the FDA broadens the label of authorized Omicron-based BA.4/BA.5 adapted bivalent boosters to include children as young as five years.

FDA Allows Emergency Use of Omicron-Based COVID Jabs in Kids

Pfizer and its German partner BioNTech said their COVID-19 vaccine booster, adapted for the BA.4 and the BA.5 subvariants, generated a strong immune response and was well tolerated in testing on humans.

Pfizer, BioNTech's updated booster protects against Omicron in human trial

Pfizer Inc. PFE, +0.26% and German partner BioNTech SE BNTX, +5.53% said Thursday early data from a Phase 2/3 clinical trial of their omicron BA.4/BA.5-adapated bivalent booster showed positive results in treating individuals aged 18 and older. The data collected 7 days after administering a 30-ug booster dose showed a “substantial increase” in neutralizing antibodies.

Pfizer and BioNTech report positive data in trial of omicron-targeting bivalent booster in individuals aged 18 and older

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced early data from a Phase 2/3 clinical trial (NCT05472038) evaluating the safety, tolerability, and immunogenicity of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)).

Pfizer and BioNTech Announce Positive Early Data From Clinical Trial of Omicron BA.4/BA.5-Adapted Bivalent Booster in Individuals 18 Years and Older

BioNTech SE - ADR (NASDAQ: BNTX) shares are trading higher by 5.37% to $136.45 going into the close of Wednesday's trading session after the FDA granted Emergency Use Authorization to the company's 10-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

Why Pfizer Partner BioNTech SE Shares Are Trading Higher - BioNTech (NASDAQ:BNTX)

The Centers for Disease Control and Prevention officially signed off on allowing children as young as 5 years old to get an updated COVID-19 booster shot. CDC Director Rochelle Walensky signed the decision memo on Wednesday afternoon, the same day that the Food and Drug Administration expanded the authorizations for Moderna Inc. MRNA, +7.75% and BioNTech SE BNTX, +4.97% /Pfizer Inc.'s PFE, +0.66% updated COVID-19 boosters.

CDC officially recommends new boosters for young children

Like Moderna's and Pfizer's updated vaccines for adults, the child doses target newer strains of COVID-19.

FDA Authorizes New COVID Boosters for Kids

Shares of Pfizer Inc. PFE, +1.99% climbed 2.2% and BioNTech SE BNTX, +4.87% hiked up 5.5% in morning trading Wednesday, after the companies said the U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) for its omicron bivalent COVID-19 booster vaccine for children aged 5 through 11. The drug makers said pending recommendation from the Centers for Disease Control and Prevention (CDC), the 10-ug booster doses, adapted for the BA.4 and BA.5 subvariants, will be shipped immediately.

Pfizer, BioNTech stocks surge after FDA grants emergency use of BA.4, BA.5 adapted booster shots in children

Uptake of the retooled coronavirus vaccine among Americans 12 years and older has lagged.

FDA Authorizes Omicron-Specific Covid Boosters For Kids 5 And Up

NEW YORK and MAINZ, GERMANY, OCTOBER 12, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-µg doses will be shipped immediately.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age

The Centers for Disease Control and Prevention still has to issue its recommendations before pharmacies can administer the new shots to kids.

FDA authorizes Covid omicron booster shots for kids as young as 5 years old

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MELBOURNE , Australia, October 7, 2022 — BioNTech SE (Nasdaq: BNTX) today announced that it has agreed a Letter of Intent with the State of Victoria in Australia on a strategic partnership between the State and BioNTech to collaborate on the research and development of potential mRNA-based vaccines and therapies. As part of the partnership, the parties will establish a research and innovation center in Melbourne to facilitate the transition of encouraging academic research into clinical development. BioNTech plans to set up a clinical scale end-to-end mRNA manufacturing facility based on its BioNTainer solution in Melbourne with the aim of supporting the design, manufacture and clinical testing of product candidates. Part of BioNTech's global network, the facility is expected to attract interest from researchers locally, regionally and globally.

BioNTech and Australia's State of Victoria Form Strategic Partnership to Establish mRNA Research Center and Manufacturing Facility

Gilead Sciences

Covid-related product sales helped make BioNTech SE ( BNTX , Financial), Moderna Inc. ( MRNA , Financial), Gilead Sciences Inc. ( GILD , Financial) and Regeneron Pharmaceuticals Inc. ( REGN , Financial) the most productive biopharma companies in 2021, according to a Fierce Pharma ranking.

Covid-Related Sales Boost BioNTech, Moderna and Gilead

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As people acclimatize to the new normal, it's time to look at some vaccine stocks to sell. Instead of relying primarily on vaccines and antiviral drugs, the government let people manage infections.

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Pfizer and German partner BioNTech said Monday they're seeking Food and Drug Administration authorization for their omicron-targeting bivalent vaccine for use in children 5 to 11 years of age.

Pfizer and BioNTech seek authorization of omicron-targeted booster for children aged 5 to 11

Pfizer Inc. PFE, -1.10% and German partner BioNTech SE BNTX, -1.27% said Monday they have submitted an application to the U.S. Food and Drug Administration seeking an emergency use authorization for their bivalent vaccine booster for use in children aged 5 to 11 years of age. The application is for a 10-ug booster dose of the vaccine targeting omicron BA.4 and BA.5 subvariants, which have become dominant in the U.S and around the world.

Pfizer and BioNTech seek FDA EUA for omicron-targeting booster for use in children aged 5 to 11

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is suppo

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

BioNTech (BNTX), Moderna (MRNA) and Novavax (NVAX) stocks decline 8.6%, 7.1% and 6.5%, respectively.

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News for BioNTech SE Stock (BNTX)