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 and BioNTech announced Friday that they are seeking approval from the US Food and Drug Administration to store their COVID-19 vaccine at higher temperatures. New data from Pfizer shows the shots can be stored at temperatures between minus 13 degrees and 5 degrees Fahrenheit for up to two weeks as an "alternative or complement to storage in an ultra-low temperature freezer." Pfizer CEO Albert Bourla in a press release said, "We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply."

Promising new data shows Pfizer's vaccine can overcome its ultra-cold storage requirements, as new research hints at just how effective the shot is (PFE)

Pfizer (PFE) and BioNTech begin dosing in a mid-to-late-stage study on their COVID-19 vaccine in healthy pregnant women.

Pfizer (PFE), BioNTech Test COVID-19 Vaccine in Pregnant Women

The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F.

Pfizer-BioNTech's COVID-19 vaccine just got a lot easier to transport and distribute

Pfizer is seeking permission from the FDA to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers and refrigerators.

Pfizer asks FDA to approve storing Covid vaccine doses at higher temperatures

ADMA Biologics

Atea Pharmaceuticals

Lexicon Pharmaceuticals

Moderna

Let us take a look at some drug/biotech stocks that are poised to beat on fourth-quarter earnings.

4 Drug/Biotech Stocks Set to Outpace Q4 Earnings Estimates

Shares of Pfizer Inc. gained 0.1% in premarket trading on Friday after the drugmaker said it is requesting a regulatory change to the storage requirements for the COVID-19 vaccine it developed with BioNTech SE . BioNTech's stock was down 0.8%.

BioNTech, Pfizer say their COVID-19 vaccine can be stored at higher temperatures than previously thought

NEW YORK and MAINZ, GERMANY, February 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F to 5°F), temperatures more commonly found in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.

Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA

The researchers said the findings support policies delaying the second shot in efforts to stretch supplies and speed up immunizations.

Single Shot Of Pfizer-BioNTech Covid-19 Vaccine Is 85% Effective, Study Finds

The first dose of Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) vaccine could be highly efficacious against COVID-19, a study has found — fueling debate over delaying the second dose to stretch supplies, Reuters reported Thursday. What Happened: The first dose of the Pfizer vaccine could be 85% effective, according to a study of healthcare workers at Israel's Sheba Medical Center, Reuters noted.

Delay Pfizer COVID-19 Vaccine's 2nd Inoculation To Boost Supply? Here's What Research Is Saying

The testing will also be extended to children.

Pfizer and BioNTech Launch Coronavirus Vaccine Study for Pregnant Women

AstraZeneca

Johnson & Johnson

Novavax

As Covid-19 becomes endemic, rich governments will turn to Novavax to vaccinate people in developing economies. NVAX stock will benefit.

NVAX Stock Is the Most Undervalued Vaccine Maker for Endemic Covid-19

Pfizer Inc. and partner BioNTech SE said Thursday that they have commenced a clinical trial to evaluate their COVID-19 vaccine in pregnant women. The companies said the Phase 2/3 trial will enroll 4,000 health pregnant women in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the United Kindom and Spain, with the first participants dosed in the U.S. "We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations," said William Gruber, senior vice president of vaccine clinical research and development at Pfizer.

Pfizer, BioNTech have started trial to evaluate their COVID-19 vaccine in pregnant women

New York, USA and Mainz, Germany, February 18, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women 18 years of age and older.     “We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations,” said William Gruber M.D., Senior Vice President of Vaccine Clinical Research and Development, Pfizer. “Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work.”

Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women

Pfizer (PFE)/BioNTech (BNTX) win a deal for 200 million more doses of its COVID-19 vaccine in Europe.

Pfizer/BioNTech to Sell More COVID-19 Vaccine Doses to EU

A laboratory study suggests that a COVID-19 mutant strain prevalent in South Africa may lower antibody protection from the Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) vaccine and it is not clear if the shot will be effective against the mutation, reports Reuters. Though the lab study found the vaccine was still able to neutralize the virus.

Pfizer Says South African Variant Could Significantly Reduce Vaccine Protection

Pfizer Inc. and BioNTech SE said late Wednesday its COVID-19 vaccine provided protection against the South African variant of the novel coranovirus in a lab study. The study, conducted by Pfizer and the University of Texas Medical Branch and not done in humans, investigated the full set of South African variant spike mutations.

Pfizer, BioNTech COVID-19 vaccine likely to protect against South Africa strain

New York, NY and Mainz, Germany, February 17, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to neutralize SARS-CoV-2 with the South African variant spike protein. This study, which builds on previous work, was conducted by Pfizer and the University of Texas Medical Branch (UTMB), and results were published in the New England Journal of Medicine .

In Vitro Study Published in The New England Journal of Medicine Demonstrates Sera from Individuals Immunized with the Pfizer-BioNTech COVID-19 Vaccine Neutralize SARS-CoV-2 with South African Variant Spike Mutations

Pfizer-BioNTech to supply 200 million additional COVID-19 vaccine doses to EU

Pfizer has not yet delivered to the European Union about 10 million COVID-19 vaccine doses that were due in December, EU officials said, leaving it about one-third short of the supplies it had expected by now from the U.S. company.

Exclusive: Pfizer's COVID-19 vaccine supply to the EU 30% below plans, sources say

The European Commission has announced an agreement with Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) for 200 million more doses of its COVID-19 vaccine in addition to the 300 million doses committed to the EU through this year.  The EC has the option to request a supply of an additional 100 million doses.

Europe Calls On Pfizer/BioNtech For 200M More COVID-19 Vaccine Doses

An attempt by Taiwan to secure five million doses of Pfizer Inc (NYSE: PFE) / BioNTech SE's (NASDAQ: BNTX) COVID-19 vaccine failed “at the final step” of negotiations because of “political pressure,” revealed Taipei's health minister Chen Shih-Chung, during a radio interview, Bloomberg reports. Interference by “external forces” upset arrangements, Chen said.

Taiwan Puts BioNTech Vaccine Deal On Hold Due To Pressure From China

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the European Commission (EC) to supply an additional 200 million doses of COMIRNATY®, the companies' COVID-19 Vaccine, to the 27 European Union (EU) member states. The EC has the option to request supply of an additional 100 million doses. This new agreement is in addition to the 300 million doses that have already been committed to the EU through 2021 under the f

Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY®

Tensions between Taiwan and China have risen sharply during the Covid-19 pandemic as the island has accused the Chinese government of aggravating the pandemic.

Taiwan Says Deal To Buy 5 Million Pfizer-BioNTech Covid-19 Vaccines On Hold, Hints At Pressure From China

CureVac B.V

Coronavirus vaccine news supply deals and a regulatory filing are in the headlines in Friday's trading session.  US Secures More Vaccine Doses: Moderna Inc (NASDAQ: MRNA) and Pfizer Inc. (NYSE: PFE), the two companies that have received  emergency use authorization for vaccine candidates in the U.S., confirmed supply deals with the federal government.

COVID-19 Vaccine Updates: US Strikes 100M-Dose Supply Deals With Moderna, Pfizer, EU Starts Rolling Review Of CureVac Vaccine

Pfizer-BioNTech's COVID-19 vaccine was 93% effective at protecting against COVID-19, a leading Israeli healthcare provider announced Thursday. The results appear to show the shot working as hoped across a massive sample of people, raising hopes that vaccine rollouts around the world will succeed.

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