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.

Mainz, Germany, December 28, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that CEO and Co-founder Prof. Ugur Sahin, M.D., will present a corporate overview and update at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 9:45 am PST / 12:45 pm ET.

BioNTech to Present at the 41st Annual J.P. Morgan Healthcare Conference

MAINZ, Germany, December 23, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the Company") today announced the initiation of a first-in-human Phase 1 study with BNT165b1, the first candidate from the Company's BNT165 program, to develop a multi-antigen malaria vaccine candidate. BioNTech will initially evaluate a set of mRNA-encoded antigens of the malaria-causing parasite Plasmodium falciparum (P. falciparum) to help select the multi-antigen vaccine candidate to proceed to planned later-stage trials. This first clinical trial ( NCT05581641 ) will evaluate the safety, tolerability and exploratory immunogenicity of the vaccine candidate BNT165b1. BNT165b1 expresses certain parts of the circumsporozoite protein (CSP).

BioNTech Initiates Phase 1 Clinical Trial for Malaria Vaccine Program BNT165

MAINZ, GERMANY, and SHANGHAI, CHINA, December 22, 2022 (GLOBE NEWSWIRE) —  BioNTech SE  (Nasdaq: BNTX, “BioNTech” or “the Company”) and  Shanghai Fosun Pharmaceutical (Group) Co., Ltd.  (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that the companies provided approximately 11,500 doses of mRNA-based COVID-19 vaccines which arrived  on the Chinese Mainland on December 21, 2022. The delivery contains both the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and the monovalent COVID-19 vaccine.

BioNTech and Fosun Pharma Provide COVID-19 Vaccine Doses For Vaccination of German Expatriates in China

MAINZ, GERMANY, December 21, 2022 — BioNTech SE (Nasdaq: BNTX, “BioNTech”) reached the next milestone in the establishment of scalable mRNA vaccine production in Africa. The six ISO-sized shipping containers for the first BioNTainer have finished construction in Europe, underwent quality checks by BioNTech experts and are being prepared for shipment to Kigali, Rwanda, where they are expected to arrive in the first quarter of 2023. Media material from the preparation is now available here .

Update on First BioNTainer for African-based mRNA Manufacturing Facility

MAINZ, Germany, December 21, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or the "Company”) today announced that the first subject was dosed in a first-in-human Phase 1 clinical research study with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. The trial ( NCT05432583 ) will evaluate the safety, tolerability, and immunogenicity of BNT163. The mRNA vaccine encodes three HSV-2 glycoproteins with the aim of helping to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs.

BioNTech Starts Phase 1 Clinical Trial for Prophylactic Herpes Simplex Virus-2 Vaccine Candidate BNT163

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Major indices such as the S&P 500 and the Nasdaq Composite may have plunged by double-digits during 2022, but certain areas of the stock market performed strongly throughout the year. One of those areas is among the hottest healthcare stocks.

The 7 Hottest Healthcare Stocks to Own for 2023 and Beyond

BioNTech SE (NASDAQ:BNTX)  announced plans today for a clinical trial hub in Taiwan for its MRNA-based cancer immunotherapies.

BioNTech Announces Plans for Taiwan Clinical Trial Hub

Bank of America analysts upgraded BioNTech SE stock to buy from hold on Thursday, citing excitement about its mRNA technology and the outlook for a combined flu/COVID vaccine and oncology vaccines that are currently in various stages of development.

BioNTech upgraded to buy on high hopes for combined flu/COVID vaccine and oncology pipeline

BioNTech SE Sponsored ADR (BNTX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About BioNTech SE Sponsored ADR (BNTX) Rating Upgrade to Buy

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.

Is BioNTech (BNTX) Stock Undervalued Right Now?

The mean of analysts' price targets for BioNTech SE Sponsored ADR (BNTX) points to a 30.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Can BioNTech SE Sponsored ADR (BNTX) Climb 31% to Reach the Level Wall Street Analysts Expect?

Moderna

Pfizer

Amid a rise in seasonal respiratory illnesses in younger children across the country, the FDA broadens the label of authorized bivalent Omicron BA.4/BA.5-adapted vaccines to include children as young as six months.

FDA Approves Pfizer, Moderna's Omicron COVID Jabs in Younger Kids

The vaccine will work against two sublineages of Omicron and four strands of influenza.

Pfizer, BioNTech Announce FDA Fast Track for Covid, Flu Vaccine

Pfizer Inc. PFE, +3.07% and German partner BioNTech SE BNTX, +5.64% said Friday they have received fast track designation from the U.S. Food and Drug Administration for a single-dose-mRNA-based vaccine candidate targeting both COVID and flu. The companies already announced that they are in early-stage trials to review the safety and immunogenicity of their combined vaccine among healthy adults.

Pfizer and BioNTech get FDA fast track designation for single-dose COVID and flu vaccine candidate

NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.1

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

GameStop

Momo

Below we are taking a look at three popular stocks making move in today's trading, just on the heels of several earnings releases and an exciting approval from the Food & Drug Administration (FDA).

3 Stocks Making Big Midday Moves

NEW YORK & MAINZ, Germany--( BUSINESS WIRE )--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. Children in this age group can receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the bivalent vaccine to complete the primary series. Vaccine doses can be delivered immediately upon receipt of a recommendation from the U.S. Centers for Disease Control and Prevention ("CDC").

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Pfizer Inc. PFE, -0.77% and BioNTech SE BNTX, -1.63% said Monday that they asked the Food and Drug Administration to authorize their updated COVID-19 vaccine as the third dose for children between the ages of 6 months and 5 years old. Children in this age group receive three doses as their primary series of shots.

Pfizer, BioNTech ask FDA to authorize bivalent COVID vaccine in young children

Beam Therapeutics

Vertex Pharmaceuticals

Although US stocks closed mixed on Thursday, but healthcare stocks recorded gains, gaining over 0.2% in the previous session. Biotechnology stocks were among the top performers in the sector, adding around 0.5% on Thursday.

BioNTech, Vertex Pharmaceuticals And Other Big Biotechnology Stocks From Benzinga's Most Accurate Analysts - Beam Therapeutics (NASDAQ:BEAM), BioNTech (NASDAQ:BNTX)

BioNTech (BNTX) signs a research collaboration agreement with Ryvu Therapeutics to develop small molecule programs targeting immune modulation in cancer and other diseases. Stock up.

BioNTech (BNTX) Inks Research Deal With Ryvu Therapeutics

MAINZ, Germany and KRAKOW, Poland – November 30, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Ryvu Therapeutics S.A. (Warsaw Stock Exchange: RVU, “Ryvu”), a clinical-stage company developing oncology therapeutics today announced that the companies have entered into a multi-target research collaboration for several small molecule immunotherapy programs as well as an exclusive license agreement for Ryvu's STING agonist portfolio as standalone small molecules.

BioNTech and Ryvu Therapeutics Enter into Global Collaboration to Develop and Commercialize Immuno-Modulatory Small Molecule Candidates

Good things could be on the horizon when a stock surpasses the 20-day simple moving average. How should investors react?

BioNTech SE Sponsored ADR (BNTX) Just Overtook the 20-Day Moving Average

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A stock that scores a perfect 10 should be on every investor's list of stocks to buy. Any company that receives full marks on quality, value, or growth are stocks I'd considering a perfect 10.

7 Stocks on the Perfect 10 List

Pfizer-BioNTech's new bivalent Covid-19 vaccine—which targets the original strain and some Omicron subvariants—provides more protection against the virus and its omicron variants than its initial vaccine, according to a study released Friday.

New Pfizer-BioNTech Covid Vaccine Is More Effective Than The Original, Study Shows

A fresh analysis of data on the immune response generated by the bivalent COVID-19 booster showed strong results against the newer omicron sublineages, Pfizer and German partner BioNTech said Friday.

News for BioNTech SE Stock (BNTX)