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.

Pfizer

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

Moderna

Novavax

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

Vaccine Stocks Down After Biden Says Pandemic is Over

Whether the pandemic is over or not, plenty of people are still looking for protection against COVID-19.

Vaccine Stocks: Down but Not Out?

It's a mixed day for the stock market, but it's not a good day for vaccine stocks. Across the board, these names are getting sold.

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

"The pandemic is over. We still have a problem with COVID. We're still doing a low of work on it. But the pandemic is over," Biden said.

Moderna, BioNTech, and Novavax plunge after President Biden says the COVID-19 pandemic 'is over'

Stocks of the three key vaccine makers fell sharply Monday, after President Joe Biden said the pandemic is over, in an interview with "60 Minutes" that aired on Sunday. Moderna Inc. MRNA, -9.41% fell 9.2%, Pfizer Inc. PFE, -1.76% was down 1.7% and its German partner BioNTech SE BNTX, -9.15% was down 8.4%.

Vaccine stocks Pfizer, BioNTech, Moderna and Novavax slide after Biden says pandemic is over

BioNTech SE - ADR (NASDAQ: BNTX), Moderna Inc (NASDAQ: MRNA) and Novavax, Inc. (NASDAQ: NVAX) are all trading lower during Mo

Why BioNTech, Moderna And Novavax Shares Are Diving

Pfizer Inc. PFE, -0.46% and BioNTech SE BNTX, -1.64% said Friday that the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMA) has recommended the companies' COVID-19 vaccine Comirnaty be converted to standard, or "full," Marketing Authorization (MA) from conditional MA for all indications and formulations. The companies said the European Commission (EC) will review the CHMP recommendation and is expected to make a decision "soon.

Pfizer, BioNTech COVID vaccine gets CHMP recommendation for 'full' MA for all indications

NEW YORK and MAINZ, GERMANY, September 16, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for COMIRNATY® [COVID-19 Vaccine (nucleoside modified)] to standard (also referred to as “full”) Marketing Authorization (MA) for all authorized indications and formulations. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision.

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

NEW YORK and MAINZ, GERMANY, September 12, 2022 — Pfizer Inc . (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older. 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 Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union

MAINZ, Germany, September 9, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today presented positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company's novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors. The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. The data were presented in the Investigational Immunotherapy Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany.

BioNTech Presents Encouraging Phase 1/2 Follow-up Data for CAR-T Candidate BNT211 in Hard-To-Treat Solid Tumors at ESMO

JERUSALEM , Israel, and MAINZ, Germany, September 7, 2022 — BioNTech SE (Nasdaq: BNTX) announced today that Prof. Ugur Sahin, CEO and Co-founder of BioNTech, visited Israel to meet with the Minister of Economy and Industry, Major General (res.) Orna Barbivay, the Accountant General, Mr. Yali Rothenberg, and other government officials. The visit was set to promote the potential cooperation between the State of Israel, its academic institutions and BioNTech on pandemic preparedness and discuss potential research collaborations aimed at developing innovative medicines. In addition, the discussions also included the possibility of the establishment of a research and production facility in Israel.

BioNTech CEO Ugur Sahin Visited Israel to Discuss Cooperation on Pandemic Preparedness and the Development of Innovative Medicines

Pfizer (PFE) /BioNTech (BNTX) and Moderna (MRNA) get positive CHMP opinion for Omicron-targeting bivalent booster.

PFE, BNTX and MRNA Omicron Boosters Get Positive CHMP Opinion

The CDC green-lighted updated Covid boosters from Pfizer and Moderna, helping vaccine stocks edge higher Friday. The post Moderna, BioNTech Jump After CDC Green-Lights Updated Covid Boosters appeared first on Investor's Business Daily.

Moderna, BioNTech Jump After CDC Green-Lights Updated Covid Boosters

Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) develop the Omicron BA.4/BA.5-adapted bivalent vaccines at the FDA's recommendation.

FDA Authorizes Pfizer, Moderna's Omicron-Based Boosters

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30-µg booster dose of their Omicron BA.1 Bivalent COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.1 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. The European Commission will review the CHMP recommendation and is expect

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--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) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and older. An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to FDA in

Pfizer and BioNTech Granted FDA Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Ages 12 Years and Older

They still might offer solid long-term opportunities for investors.

After Double-Digit Percentage Declines, Are Vaccine Stocks Buys?

Moderna's complaint is focused on two critical innovations.

Could This Move by Moderna Cost Pfizer Billions?

Moderna is suing Pfizer and BioNTech over patents it said it filed years ago on the life-saving technology.

Moderna Sues Pfizer Over mRNA Technology Used in COVID Vaccines

Moderna filed a lawsuit against Pfizer and BioNTech claiming the biopharmaceutical companies infringed on Moderna's patents related to mRNA technology in develop of their COVID-19 vaccine. The lawsuit, to be filed in the U.S.

Moderna sues Pfizer, BioNTech over alleged mRNA patent infringement

Moderna Inc. on Friday filed lawsuits against Pfizer Inc. and German partner BioNTech SE, alleging the pair infringed patents relating to its mRNA platform, a key technology behind all of their COVID vaccines.

Moderna sets up clash with Pfizer and BioNTech with patent lawsuits in the U.S. and Germany

Some 16 million Americans of working age have long-term COVID and about 2 to 4 million are not working as they struggle with their symptoms, according to a new report from the Brookings Institution.

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