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.

The U.S. government wants to buy more of its coronavirus vaccine.

Why BioNTech Stock Advanced Today

Pfizer

Pfizer Inc. PFE, +0.55% and BioNTech SE BNTX, +1.54% said late Wednesday they have inked a new agreement with the U.S. government to supply 105 million doses of their COVID-19 vaccines, including a formulation adapted to target omicron variants, pending approval from the FDA. The two pharma companies said the doses are expected to be delivered as soon as late summer, and continue into the end of the year.

U.S. to pay $3.2 billion to Pfizer, BioNTech for more COVID-19 vaccines for fall

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as

Pfizer and BioNTech Announce New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine

Moderna

The FDA's VRBPAC committee recommends updated COVID-19 vaccine boosters that target the Omicron variant to improve vaccine effectiveness.

FDA Panel Recommends Modifying COVID Jabs to Target Omicron

Its latest COVID-19 vaccine appears to be effective against the most common viral variants.

Why BioNTech Stock Rose Today

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) said the modified vaccine against the omicron coronavirus variant generated a higher immune response. The companies said that 30 µg and 60 µg doses of a shot targeting just the BA.1 omicron subvariant elicited a.

Pfizer/BioNTech's Updated Omicron-Based COVID-19 Shots Show Improved Response Against Variant

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NEW YORK and MAINZ, GERMANY, JUNE 25, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive data evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of the Pfizer-BioNTech COVID-19 Vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2/3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.1 as compared to the companies' current COVID-19 vaccine. The robust immune response was seen across two investigational dose levels, 30 µg and 60 µg.

Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron

MAINZ, Germany, June 23, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to BioNTech's fully owned product candidate BNT211 for the third- or later-line treatment of testicular germ cell tumors. BNT211 is a potential first-in-class therapeutic approach which comprises a synergistic combination of two of the Company's proprietary drug products, an autologous chimeric antigen receptor (CAR) T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate is currently being investigated in an ongoing Phase 1/2 study ( NCT04503278 ; 2019-004323-20 ) that aims to evaluate the safety and preliminary efficacy in heavily pretreated patients with relapsed or refractory advanced solid tumors.

BioNTech Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate BNT211 in Testicular Cancer

BioNTech SE BNTX, +0.33% said Thursday it has broken ground on the construction of the first mRNA manufacturing facility in Africa, a plant in Kigali, Rwanda that is expected to employ about 100 workers by 2024. The first of two BioNTainers are expected to be delivered by year-end and the company's malaria vaccine candidate is expected to enter its first in-human trial later in 2022.

BioNTech breaks ground on first mRNA manufacturing facility in Africa in Kigali, Rwanda

MAINZ, Germany and KIGALI, Rwanda, June 23, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech”) has reached the next milestone in the establishment of scalable mRNA vaccine production in Africa on its planned schedule. Today, BioNTech welcomed its African partners for the first time on the African continent as construction works for the initial African mRNA manufacturing facility began in Kigali, Rwanda, with a target for the first set of manufacturing BioNTainers to be delivered to the site by the end of 2022. The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries. The initial site will become a node in a decentralized and robust African end-to-end manufacturing network. All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union.

BioNTech Starts Construction of First mRNA Vaccine Manufacturing Facility in Africa

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FDA authorizes Pfizer (PFE) and BioNTech's Comirnaty for use in children aged six months through four years. Moderna's (MRNA) Spikevax gains EUA for use in individuals aged 6 months through 17 years.

FDA Authorizes PFE & MRNA's COVID Jabs for 6 Months & Older Kids

MAINZ, Germany, June 20, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or the "Company”) will host the first edition of the Company's Innovation Series on Wednesday, June 29th, 2022. The virtual event will provide an update on BioNTech's clinical progress across its pipeline and provide a deep-dive on scientific and technology innovation from its proprietary research engine.

BioNTech to Host First Edition of Innovation Series on Diversified Pipeline, Latest Technology Innovations

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Despite continued skepticism from parents and some scientific advisers, the Centers for Disease Control and Prevention on Saturday recommended Covid-19 vaccines for children as young as 6 months. The ruling means young children could be injected as soon as Tuesday. Covid-19 has been stubbornly resistant to fading away, and new cases are still rising in...

Covid-19 Vaccinations For Children Starting At Age 6 Months Approved By CDC

Very young children may be able to start receiving shots early next week.

CDC Advisers Recommend COVID Vaccines for Kids as Young as 6 Months Old

"We've taken a major step forward today," said Dr. Oliver Brooks, one of the members of the advisory panel.

CDC panel recommends COVID-19 vaccine for children as young as 6 months old

U.S. health advisers on Saturday recommended COVID-19 vaccines for infants, toddlers and preschoolers — the last group without the shots.

CDC advisers recommend COVID-19 shots for children under 5

Shots are expected to start going in arms next week.

CDC Panel Recommends Covid Vaccines For Young Children

The CDC committee voted unanimously to recommend the shots for use in infants through preschoolers after two days of meetings that were open to the public.

CDC advisors recommend Covid vaccines for children as young as 6 months

Pending the CDC's signoff, both Moderna and Pfizer shots could be available for the youngest children within days.

FDA Approves COVID Vaccines for Kids as Young as 6 Months Old

The vaccines will be available for young children once the CDC recommends them, which will likely happen this weekend.

FDA authorizes Pfizer and Moderna COVID-19 vaccines for children as young as 6 months old

The Food and Drug Administration announced Friday that it authorized the COVID-19 vaccines developed by BioNTech SE BNTX, -6.41% /Pfizer Inc. PFE, -2.12% and Moderna Inc. MRNA, -5.80% for children as young as six months old. The regulator said Moderna's two-dose vaccine is now authorized for children between the ages of 6 months old and 17 years old.

FDA authorizes both mRNA vaccines for young children

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 the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, a

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