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 final green light decision now rests in the FDA's hands.

FDA Advisory Committee Recommends Emergency Authorization for Pfizer's COVID Vaccine

The vote is the final step needed before the FDA makes it's approval decision, which could happen as soon as Friday.

FDA Advisory Committee Recommends Authorization of Pfizer's Covid Vaccine

Now it's up to the FDA to decide whether to accept that recommendation. Pfizer says the vaccine has shown 95% effectiveness in clinical trials.

FDA panel backs Pfizer's COVID-19 vaccine for emergency use in US

The Food and Drug Administration will now make the final decision on whether to authorize the experimental vaccine.

Medical experts vote in favor of FDA authorization of BioNTech/Pfizer COVID-19 vaccine candidate

An independent panel of experts has recommended Food and Drug Administration (FDA) has now voted to approve an official Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine. This means that it's one step closer to beginning to be administered to people in special circumstances – including for front-line healthcare workers dealing with healthcare facilities […]

FDA panel recommends approving Pfizer's COVID-19 vaccine emergency use authorization

A committee of 22 leading scientists and doctors just voted 17 to 4, with one abstention, encouraging the US Food and Drug Administration to grant emergency use authorization for Pfizer's COVID-19 vaccine in the US. Their vote is not a final verdict, it's really just advice.

An influential expert panel just gave its blessing to Pfizer's 2-dose coronavirus shot, teeing up the FDA to imminently authorize the US' first COVID-19 vaccine

The US government advisory panel has recommended the Pfizer COVID-19 be approved for use.

Pfizer COVID-19 vaccine recommended for approval by US government advisory panel

AstraZeneca

Moderna

The time to pick your horse in the vaccine race was months ago. These stocks were much cheaper before their trials started.

The Question to Ask About COVID-19 Vaccine Stocks

Two people reported severe allergic reactions to Pfizer and BioNTech's Covid-19 vaccine when it was rolled out in the U.K.

How Safe Is Pfizer's Covid-19 Vaccine? Here's What You Should Know About Reports Of Allergic Reactions In Britain

The Bell's palsy related side-effects are not alarming enough to preclude FDA from granting emergency approval to Pfizer (PFE)/BioNTech's (BNTX) COVID-19 vaccine.

Pfizer/BioNTech COVID-19 Vaccine Raises New Safety Concerns

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerat

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

A panel of independent experts is meeting today to evaluate Pfizer's coronavirus vaccine. By day's end, they're expected to come to a vote that will advise the US Food and Drug Administration (FDA) to approve or deny the shot for emergency use.  But FDA Commissioner Dr. Stephen Hahn said the outcome is already predictable, and that the agency intends to act on the advisory panel's advice immediately. 

FDA director: The agency expects to approve Pfizer's vaccine after today's crucial hearing

The feds will likely scrutinize recent allergic reactions to Pfizer's coronavirus vaccine before clearing it for emergency use, the government's top vaccine adviser said. Two people who received the groundbreaking COVID-19 shot in the UK suffered severe allergic reactions to it, leading British health officials to warn that individuals with “significant” allergic reactions may not.

FDA likely to weigh allergic reactions of Pfizer's COVID-19 vaccine

A Food and Drug Administration panel will meet Thursday to discuss Pfizer's BioNTech-partnered coronavirus vaccine. The results could spark Pfizer stock and BioNTech stock.

Pfizer Stock Faces Its Next Big Covid Challenge: An FDA Committee

Documents for the Pfizer-BioNTech Covid-19 vaccine were 'unlawfully accessed' in a cyberattack on the European Medicines Agency.

Pfizer-BioNTech vaccine documents were ‘unlawfully accessed' in a cyberattack on Europe's medicines agency

Pfizer Inc (NYSE: PFE) and its German partner BioNTech SE (NASDAQ: BNTX) said on Wednesday that hackers illegally accessed documents related to their COVID-19 vaccine in an attack on the European Medicines Agency (EMA). What Happened: The two companies said in a statement they believe the personal data of trial participants were not compromised and that the EMA had assured them that the incident would not impact the timeline of the vaccine's review.

Pfizer, BioNTech Say Hackers Accessed COVID-19 Vaccine Development Data

It was the third authorization of BNT162b2 by a national healthcare regulator in the space of a week.

Pfizer and BioNTech's Coronavirus Vaccine Approved in Canada

The soaring shares of vaccine makers has created a new wave of billionaires, raising questions about pandemic profits amidst an increasingly unequal recovery.

New vaccine billionaires gain wealth as Moderna and BioNTech shares soar

Shares of BioNTech were down 0.6% and Pfizer Inc.'s stock fell 1.1% in trading on Wednesday after the companies announced that their COVID-19 vaccine candidate had received emergency authorization in Canada. This is the third country, after Bahrain and the United Kingdom, to authorize their coronavirus vaccine.

Canada authorizes BioNTech/Pfizer COVID-19 vaccine

Canada approved Pfizer and BioNTech's coronavirus vaccine for use, the country's health department announced on Wednesday. The UK made a similar decision earlier this month, but the vaccine is still awaiting authorization for emergency use in the US.  The vaccine, made by US drugmaker Pfizer and German biotech firm BioNTech, is 95% effective at preventing COVID-19, according to the company's Phase 3 trials. Pfizer predicts it will produce up to 50 million vaccine doses for global distribution by the end of 2020, and up to 1.3 billion doses in 2021.

Canada beats the US to approving Pfizer and BioNTech's coronavirus vaccine

Pfizer stock toppled Wednesday on reports of two allergic reactions after the U.K. began its widespread coronavirus vaccine campaign. Both were staff members of the National Health Service.

Pfizer Stock Trips After U.K. Notes Possible Allergic Reactions To Covid Vaccine

Both Canada and the U.K. have now approved the vaccine for emergency use. It's still under review in the U.S.

Canada Approves Pfizer's Coronavirus Vaccine

As early as next week, the Department of Defense is slated to receive nearly 44,000 of the first dose of Pfizer's coronavirus vaccine.

Pentagon reveals plans to distribute first 44,000 doses of Pfizer vaccine as early as next week

KIRKLAND, QUEBEC, CANADA and MAINZ, GERMANY, December 9, 2020 (GLOBE NEWSWIRE) — Pfizer Canada and BioNTech SE (Nasdaq: BNTX) today announced that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations (NACI). BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.

Pfizer and BioNTech Achieve Health Canada Authorization for Their Vaccine to Combat COVID-19

Tuesday, the U.K. became the first country in the West to roll out a Covid-19 vaccine, administering Pfizer's vaccine less than a week after British regulators gave the go-ahead to begin mass inoculations.

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