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, Inc. (NYSE:PFE)-BioNTech SE (NASDAQ:BNTX) suffered a setback last week after a FDA panel did not recommend a third dose of the duo's COVID-19 vaccine for the broader population. The Pfizer-BioNTech Analysts: Morgan Stanley analyst Matthew Harrison maintained an Equal-weight rating and $45 price target for Pfizer shares.

Pfizer, BioNTech Analysts On FDA Panel's COVID-19 Booster Dose Decision

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Pfizer (PFE) and Moderna (MRNA) are the only two companies that have submitted data and are seeking approval for a booster or "third" dose of their COVID-19 vaccines.

FDA Panel Vetoes PFE/BNTX Third Jab for All, Vaccine Stocks Down

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced results from one cohort from a Phase 2/3 trial evaluating its COVID-19 vaccine on a two-dose schedule (approximately 21 days apart). The data from over 2,200 children aged 5 to 11 years showed a favorable safety profile and robust neutralizing antibody responses using a two-dose regimen of 10 µg, a smaller dose than the 30 µg dose used for people 12 and older.

Pfizer/BioNTech COVID-19 Vaccine Data For Kids Is Here: What You Need To Know

Pfizer and BioNTech's intend to apply for approval for their Covid-19 vaccine to be given to children after a trial showed it to be safe and rapidly built up resistance to the virus. Children received two doses of the vaccine 21 days apart in what was the first major trial of a covid vaccine for those under the age of 12, Antibody responses in the participants were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunised with three times larger doses, said the firms.

Pfizer and BioNTech to seek approval to vaccinate children after Covid study

NEW YORK AND MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfiz

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years

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NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. The committee recommended that the ad

FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations

A month after Joe Biden laid out a plan for Americans to get a vaccine booster shot to help contain the coronavirus pandemic and the deadly Delta variant, a pivotal advisory panel to the Food and Drug Administration today partially kicked the legs out from the President's proposal. In a whirlwind of mixed messages, the...

Influential FDA Panel Votes Down Widespread Pfizer Booster; Approves Third Shot For 65 & Older + Those At “High Risk”

Pfizer, Inc. (NYSE: PFE)-BioNTech SE (NASDAQ: BNTX) shares are sliding after a Food and Drug Administration panel voted against recommending a third dose of their COVID-19 vaccine, Comirnaty, to the general population. What Happened: FDA's Vaccines and Related Biological Products Advisory Committee met Friday to discuss Pfizer-BioNTech's supplemental biologics license application for Comirnaty for the administration of a third dose, or "booster" dose, of the COVID-19 vaccine, in individuals 16 years of age and older.

FDA Panel Votes Against Approval Of Pfizer/BioNTech's COVID-19 Booster Shot For General Public

In a follow-up vote, the panel voted that the benefits of a third dose for older adults and individuals at high risk of severe COVID-19 outweigh the risks.

FDA panel votes against Pfizer booster for general public

The group of independent experts, which informs the FDA's decision on vaccine approval, argued there isn't enough evidence to support the need for a third dose of Pfizer's vaccine.

FDA Advisory Panel Recommends Against Pfizer Covid Boosters—Except For People Over 65

A group of advisors to the Food and Drug Administration said Friday the regulator should not allow Americans to get a third dose of BioNTech SE and Pfizer Inc.'s COVID-19 vaccine.

FDA committee votes against approving BioNTech and Pfizer's COVID-19 booster

An influential FDA advisory committee on Friday rejected a proposal to distribute booster shots of Pfizer and BioNTech's Covid-19 vaccine to the general public.

FDA panel rejects plan to administer Pfizer's Covid booster doses to general public

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The two companies' respective coronavirus vaccines both receive a new regulatory nod.

Why Moderna and BioNTech Topped the Market Today

Amid rising coronavirus cases, PFE and MRNA are trying to make booster doses of their COVID-19 vaccine available for US citizens. An FDA meeting is scheduled tomorrow to discuss Comirnaty's booster dose.

Pfizer, Moderna Support COVID Vaccine Booster Before FDA Meet

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Pfizer Inc (NYSE: PFE) said that U.S. regulators should approve a booster dose of the COVID-19 vaccine developed with BioNTech SE (NASDAQ: BNTX) six months after the second dose due to the waning effectiveness of the shot over time. The FDA released Pfizer's detailed case to the agency and its outside advisors for authorizing COVID-19 booster doses.

Pfizer Builds Case For COVID-19 Booster As Protection Wanes Over Time

Side effects from Covid booster shots are similar to those felt after the second dose and are more likely to affect younger people, Pfizer said in new data submitted to the Food and Drug Administration as it seeks approval to distribute booster shots across the U.S.

Pfizer submits data to FDA showing side effects from Covid booster shots are similar to the second dose

Shares of Pfizer Inc. PFE, +0.04% gained 0.1% in premarket trading on Wednesday after the drug maker said the "totality" of clinical data indicates that people who are at least 16 years old and were vaccinated with the COVID-19 shot that it developed with BioNTech SE BNTX, +3.81% should get a booster after six months. In a document published Wednesday morning by the Food and Drug Administration in advance of an advisory committee meeting set for Friday, Pfizer said its Phase 3 substudy examined 306 people between the ages of 18 and 55 years old who got a third dose.

Pfizer cites 'totality' of clinical data in bid for COVID-19 booster approval

A panel of independent experts are set to meet on Friday to debate whether people should get boosters of the Pfizer-BioNTech COVID-19 shot.

FDA releases documents outlining Pfizer's case for COVID-19 booster shots

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Booster shots of its vaccine will be part of an important anti-COVID push in the U.K.

Why BioNTech Topped the Market on Tuesday

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News for BioNTech SE Stock (BNTX)