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 B.1.1.529 variant has been detected in South Africa, Botswana, Hong Kong, and Israel, and is spreading rapidly.

BioNTech says it will know in 2 weeks whether the COVID-19 vaccine it developed with Pfizer works against the new variant rapidly spreading in southern Africa

Pfizer (PFE)/BioNTech (BNTX) COVID-19 vaccine, Comirnaty, if approved for use in children aged five to 11, will be the first vaccine to be approved for administration in this age group in Europe

Pfizer/BioNTech's COVID Jab Gets CHMP Nod for Kids Aged 5-11

The stock price of BioNTech SE (NASDAQ: BNTX) increased by over 7% pre-market today. This is why it happened.

BioNTech (BNTX): Why The Price Jumped Today

BioNTech (BNTX) Stock: Why The Price Jumped Today

The European Medicines Agency's (EMA) human medicines committee (CHMP) recommended using Pfizer Inc (NYSE: PFE) - BioNTech SE's (NASDAQ: BNTX)'s COVID-19 vaccine, Comirnaty, for children between 5 to 11. Pfizer-BioNTech's vaccine will be given in two 10-microgram doses three weeks apart as an injection in the upper arm, per the EMA recommendation.

Europe's CHMP Backs Pfizer/BioNTech's COVID-19 Shot For Kids Aged 5-11 Years

NEW YORK and MAINZ, Germany, November 25 , 2021— Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 EU member states. If approved, COMIRNATY will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age.

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union

BioMarin Pharmaceutical

Longeveron

Arcus Biosciences

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Moderna

The FDA authorizes booster doses of COVID-19 vaccines of PFE/BNTX and MRNA for use in all adults irrespective of the risk of exposure to coronavirus.

FDA Authorizes PFE & MRNA's COVID-19 Boosters for All Adults

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 Vaccine in individuals 12 through 15 years of age. The updated findings from the Phase 3 trial show that a two-dose series of the Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

Pfizer-BioNTech's COVID-19 Vaccine Shows 100% Effectiveness In Long Term Analysis In Adolescents

Pfizer and BioNTech said the long-term data, measured from seven days to four months after the second dose, would form the basis of a submission for full regulatory approval.

Pfizer's Covid-19 Shot Offers 100% Long-Term Protection For Young Teens, Trial Shows

Pfizer Inc. PFE, -1.19% and BioNTech SE BNTX, +5.73% said Monday that topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in people 12 through 15 show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-ug per dose) was 100% effective against COVID-19. The follow-up test measured seven days through four-plus months after the second dose.

Pfizer and BioNTech say late-stage trial shows vaccine effective for 12- to 15-year-olds

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) today announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age. The updated findings from the companies' pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second

Follow-Up Data From Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age

The German biotech delivered another strong quarter.

How Good Were BioNTech's Q3 Results?

The FDA's approval of coronavirus vaccine boosters wasn't the only reason for the stock's pop.

Why BioNTech Stock Was Blasting 20% Higher This Week

FDA Gives Authorization to Two COVID-19 Boosters

Adults who receive booster vaccine shots will be much more highly immunized from Covid-19 than those simply "fully vaccinated."

FDA Authorizes Covid Boosters; New Fed Chair Soon?

Novartis

Investment group EQT and members of the Struengmann family, who are investors in Biontech, are considering a joint bid for Swiss pharmaceutical group Novartis's generics division Sandoz, German newspaper Handelsblatt reported on Friday, citing unnamed sources.

EQT, Biontech investor family consider Sandoz bid - Handelsblatt

The FDA has authorized Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) COVID-19 booster shots for all U.S. adults. The agency extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older.

COVID-19 Booster Shots From Moderna, Pfizer/BioNTech Score FDA Nod All Adults

Shares of Pfizer Inc. PFE, +1.56% rose 2.1% and of Germany-based partner BioNTech SE BNTX, +3.44% climbed 4.2% in morning trading Friday, after Health Canada authorized use of the companies' COVID-19 vaccine in children 5 to 11 years old. That's the first vaccine authorized in Canada for that age group.

Pfizer, BioNTech COVID-19 vaccine authorized in Canada for children 5 to 11 years of age

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) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series. “As we ne

Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older

MAINZ, GERMANY, November 19, 2021 — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTech's fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer. The vaccine candidate is currently being investigated in a Phase 2 trial (EudraCT No.: 2020-002195-12 ;  NCT04526899 ) in patients with anti-PD-1-refractory/relapsed unresectable Stage III or IV melanoma.

BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma

Yes -- if the FDA focuses on protection against coronavirus infection.

Will Pfizer and BioNTech Win Authorization for Boosters for All Adults?

Ocugen, Inc.

Cassava Sciences Inc

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The FDA said it would review Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) request to authorize COVID-19 booster doses of COVID-19 vaccine in all adults "as expeditiously as possible," with the New York Times reporting that the nod could come as soon as Thursday. The agency said it does not plan to hold a meeting of the outside experts on Pfizer's request.

FDA Plans Quick Review of Pfizer/BioNTech COVID-19 Booster For All Adults: NYT

Novavax

Political messaging around the necessity of covid booster shots is once again following the “optics” script rather than the scientific script. The SARS-CoV-2 virus is a permanent addition to human infectious viruses. It's here to stay.

News for BioNTech SE Stock (BNTX)