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

The UK has approved Pfizer and its German partner BioNTech's COVID-19 vaccine — but regulators in the US are yet to make a decision on authorization. The UK's vaccine regulator approved the shot Wednesday morning, making it the first western country to authorize a COVID-19 vaccine. Vaccinations will start next week, the government said.

The UK has approved Pfizer and BioNTech's COVID-19 vaccine, but the US is still waiting. Here's why.

The U.K. has become the first country to approve the Pfizer-BioNTech Covid-19 vaccine, with preparations under way to begin the rollout next week.

U.K. Becomes First Country to Approve Pfizer's Covid-19 Vaccine

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Johnson & Johnson

Moderna

Novavax

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COVID Vaccine Stocks Update: Where Things Stand Now

The vaccine will be available across the U.K. starting next week with the elderly and frontline healthcare workers being the first to receive a shot.

U.K. Approves Pfizer-BioNTech's Covid-19 Vaccine, The First Country To Do So

U.K. becomes first country to approve a coronavirus vaccine, with immunisations to start within days for those most at risk

Pfizer and BioNTech's COVID-19 vaccine wins U.K. approval — rollout to begin next week

This is an historic moment. The beginning of the end of the pandemic.

Vaccine approval is a historic moment for the UK

The UK's medicines regulator has approved the BioNTech/Pfizer vaccine against COVID-19 for emergency use, the companies said today. The UK is the first country to approve the vaccine for widespread use — paving the way for some of the most “high risk” citizens, such as elderly care home residents, to get the jab before the end […]

The UK approves the BioNTech/Pfizer COVID-19 vaccine for emergency use

Pfizer Inc (NYSE: PFE) and its German partner BioNTech SE (NASDAQ: BNTX) said Wednesday they have received regulatory approval in the United Kingdom for their COVID-19 vaccine. What Happened: The go-ahead from the Medicines and Healthcare Products Regulatory Agency (MHRA) means the U.K. has become the first country to approve a COVID-19 vaccine on an emergency basis ahead of the United States and the European Union.

Pfizer-BioNTech COVID-19 Vaccine Gets UK Approval For Emergency Use

The UK has become the first Western country to officially have a new coronavirus vaccine, marking a potential exit route out of the pandemic. And it's happened in record time.   The vaccine developed by US drugmaker Pfizer and the small German biotech, BioNTech, can be used in the UK, after the independent regulatory body in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) signed off the vaccine.

Regulator says yes to Pfizer and BioNTech: UK becomes first Western country to have a coronavirus vaccine

The U.K. has authorized the Pfizer/BioNtech coronavirus vaccine, making it the first country in the world to do so.

UK becomes first country to approve the Pfizer-BioNTech coronavirus vaccine for use

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulat

Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19

The European Medicines Agency said Tuesday it has received conditional marketing approval applications from Pfizer Inc. (NYSE: PFE)-BioNTech SE – ADR (NASDAQ: BNTX) and Moderna Inc (NASDAQ: MRNA), the two frontrunners in the development of a coronavirus vaccine.  The decision isn't likely to come early, thereby pushing out the vaccine launch timeline.

European Drug Regulator Gives 6-Week Time Frame For Opinions On Pfizer-BioNTech, Moderna COVID-19 Vaccines

United Continental Hlds

The COVID-19 vaccine has taken flight en route to the US.  Pfizer has tasked United Airlines with transporting the first doses of its vaccine to the US, the Wall Street Journal reported on Friday, in preparation for an expected emergency authorization from the Food and Drug Administration scheduled to come in the upcoming weeks.

How United Airlines overcame one of the largest limitations to being transporting Pfizer's COVID-19 vaccine to the US

Moderna and Pfizer applied to the EU's vaccine regulator this week.

Europe May Not Get Covid-19 Vaccine Before 2021, Earliest Approval Process Scheduled For December 29

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Eli Lilly

Shares of Moderna, Inc. (MRNA), Pfizer, Inc. (PFE) and AstraZeneca plc (AZN) are poised for substantial gains on encouraging final-stage trial results.

COVID-19 Vaccine Race Heats Up: Drugmarkers on Final Lap

Pfizer and BioNTech have asked European regulators for conditional approval of their experimental coronavirus vaccine — and officials say they could make a decision by the end of the month. The companies said they submitted an application to the European Medicines Agency on Monday for a conditional marketing authorization for their COVID-19 shot, which was.

Pfizer, BioNTech seek COVID-19 vaccine approval in Europe

Pfizer and its German partner BioNTech said Tuesday they have asked the European Union to approve their COVID-19 vaccine, but that distribution is unlikely to start until January. After submitting an application on Monday to the European Medicines Agency (EMA), the drugmakers said the EU regulator accepted the application on Tuesday, per the Wall Street Journal.

Pfizer and BioNTech have asked the EU to approve their vaccine — but first shots might not come until next year

Shares of Pfizer Inc. rallied 2.8% while Germany-based BioNTech SE dropped 2.5% in premarket trading Tuesday, after the company said they submitted their COVID-19 vaccine candidate BNT162b2 for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA). If the EMA recommends granting a CMA, that could lead to use of BNT162b2 in Europe before the end of 2020.

Pfizer, BioNTech apply for CMA in Europe for COVID-19 vaccine candidate

Pfizer Inc and BioNTech have applied to the European drugs regulator for conditional authorization of their COVID-19 vaccine, following similar steps in the United States and Britain, the companies said on Tuesday.

Pfizer-BioNTech apply for EU emergency authorization for COVID-19 vaccine

Here's what it means -- and doesn't mean.

This COVID Vaccine Is Already Shipping

Pfizer and BioNTech said they have applied to the European Medicines Agency for the conditional marketing authorization of their coronavirus vaccine.

Pfizer, BioNTech apply for coronavirus vaccine approval in Europe

NEW YORK and MAINZ, GERMANY, December 1, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have submitted on Monday, November 30, 2020, a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. This submission completes the rolling review process initiated on October 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data submitted by Pfizer and BioNTech. If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA that could potentially enable use of BNT162b2 in Europe before the end of 2020.

Pfizer and BioNTech Submitted Application for Conditional Marketing Authorization for COVID-19 Vaccine to the EMA

The U.K. government has told NHS hospitals to be ready to distribute the COVID-19 vaccine manufactured by Pfizer and BioNTech as soon as next Monday.

This could be the first country to distribute the Pfizer-BioNTech vaccine, as Moderna seeks FDA approval

COVID-19 infections fall 30% across England in second lockdown, study finds.

Pfizer-BioNTech vaccine could be approved ‘within days,' with U.K. set to be first to start COVID-19 shots

The U.K. has secured two million more doses of COVID-19 vaccine from Moderna Inc (NASDAQ: MRNA) and is expected to approve the vaccine made by Pfizer Inc (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) this week. What Happened: Moderna is to provide another two million vaccines to the U.K., in addition to a previous 5 million doses, Reuters has reported.

News for BioNTech SE Stock (BNTX)