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. and BioNTech SE said Thursday they have initiated the evaluation of a third dose of their COVID-19 vaccine, to study the effect of a booster on new SARS-CoV-2 variants. The study will draw on participants of its Phase 1 study in the U.S., who will be offered the opportunity to receive a booster of the current vaccine six to 12 months after receiving their initial two doses.

Pfizer, BioNTech to test a COVID-19 vaccine booster against new SARS-CoV-2 variants

A real-world study of the coronavirus vaccine developed by Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) showed the drug to be 94 percent effective at preventing COVID-19. What Happened: The large-scale study conducted in Israel found the two-dose vaccine reduced symptomatic cases by 94 percent one week after the second dose and also reduced the severity of the disease by 92 percent, Nikkei Asia reported on Thursday.

Pfizer-BioNTech Vaccine 94% Effective In Real World: Study

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The study will draw upon participants from the Phase 1 study in the United States who will be offered the oppor

Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

The FDA has signaled an eagerness in recent days for progress on vaccines that can offer protection from the emerging variants.

Pfizer Will Test Third Dose of Vaccine to Protect Against Variants

Pfizer and BioNTech announced this morning that they plan to study the effects of a third COVID-19 vaccine dose in participants from its original clinical trial. The companies will offer booster shots to up to 144 participants six to 12 months after they received their second dose of the vaccine. The Phase 1 trial kicked off in May 2020, so some people who participated are already eligible for their third doses.

Pfizer is testing out a 3rd booster shot to bolster its COVID-19 vaccine against new variants

Moderna

Pfizer sees $15 billion revenue from the Pfizer/BioNTech COVID vaccine in 2021 and it could completely change Pfizer's revenue and earnings trajectory. Think about what this will do for BioNTech. The above revenues are for the “pandemic phase.” Pfizer/BioNTech may be considering a 3-4x price increase for their COVID-19 vaccine(s) after this phase. Read this sentence again.

COVID-19 Continues, But Good Times For mRNA Vaccine Developers Pfizer/BioNTech And Moderna

The FDA has accepted  Pfizer Inc's (NYSE: PFE) marketing application seeking approval for TicoVac under priority review status. TicoVac is the tick-borne encephalitis (TBE) vaccine for active immunization in individuals aged one and older.

Pfizer's Tick-Borne Encephalitis Vaccine Gets Priority Review Tag In US

Johnson & Johnson

Pfizer Inc. (NYSE: PFE), Moderna Inc. (Nasdaq: MRNA) and Johnson & Johnson (NYSE: JNJ) said they are committed to making a total of 240 million doses of COVID-19 vaccines available in the U.S. by the end of March. What Happened: The drug makers told a House subcommittee on Tuesday they are working on ramping up production of their vaccines to meet demand.

Pfizer, Moderna, J&J Pledge To Make 240M COVID-19 Vaccine Doses Available In US By March-End

Pfizer and Moderna said Tuesday they're making improvements that will allow them to deliver more vaccines in the coming months.

Pfizer And Moderna To Dramatically Increase Covid-19 Vaccine Production This Spring

On BioNTech's (BNTX) fourth-quarter earnings call, investors are likely to focus on sales number for its COVID-19 vaccine, BNT162b2, which has been developed in partnership with Pfizer.

What's in the Cards for BioNTech (BNTX) This Earnings Season?

Last week, there were two positive developments relating to Pfizer and its German partner BioNTech's Covid-19 vaccine, and one possible negative development. Firstly, Pfizer says based on internal testing that its vaccine can tolerate warmer temperatures than initially specified, possibly making.

Pfizer Vaccine Updates: Possibly Easier Storage, Efficacy Against South African Strain

Eli Lilly

Regeneron Pharmaceuticals

The FDA encourages companies to evaluate the impact of COVID-19 virus variants on the efficacy or performance of their COVID-19 vaccines, tests and medicines.

FDA Issues New Guidelines for COVID-19 Vaccines, Tests, Drugs

2 Reasons Pfizer's COVID Vaccine Prospects Just Got Even Better

“We should be very encouraged by these initial findings,” said the head of Public Health England.

Pfizer Vaccine Highly Effective After Just One Dose, U.K. Early Data Suggest

An initial dose of the vaccine made by Pfizer and BioNTech cuts the risk of coronavirus infection, Public Health England announced on Monday as U.K. Prime Minister Boris Johnson confirmed plans to relax lockdown rules.

Pfizer vaccine reduces coronavirus-infection risk, Public Health England says

The Israel health ministry said that Pfizer Inc (NYSE: PFE) and BioNtech SE's (NASDAQ: BNTX) COVID-19 vaccine had proved 95.8% effective in preventing coronavirus infection among those vaccinated two weeks after receiving their second shot, compared to unvaccinated people, according to data compiled up to February 13. The shot appeared to stop the vast majority of vaccine recipients in Israel from COVID-19 infection, providing the first real-world indication that the immunization will curb transmission of the coronavirus, the health ministry reported.

Pfizer/BioNtech's COVID-19 Shot Staved Off Illness, Death For Over 95% Of Israeli patients

That's good news for the rest of the world.

Pfizer's Covid Vaccine Over 95% Effective In Israel, New Study Reportedly Shows

The new findings promise simpler transport, storage, and administration for BNT162b2.

Pfizer and BioNTech Coronavirus Vaccine Effective After 1 Dose, Can Last 2 Weeks in Standard Freezer, Separate Research Shows

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

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.

News for BioNTech SE Stock (BNTX)