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BioNTech SE American Depositary Share - BNTX STOCK NEWS

Welcome to our dedicated page for BioNTech SE American Depositary Share news (Ticker: BNTX), a resource for investors and traders seeking the latest updates and insights on BioNTech SE American Depositary Share stock.

BioNTech SE (American Depositary Share - BNTX) is a leading biotechnology company based in Germany, renowned for its pioneering work in the field of immunotherapy and vaccines. BioNTech's core business revolves around developing innovative cancer treatments and vaccines for infectious diseases, including the widely recognized COVID-19 vaccine, Comirnaty, which it co-developed with Pfizer.

BioNTech's oncology pipeline encompasses several advanced drug classes, including mRNA-based drugs that encode antigens, neoantigens, cytokines, and antibodies. The company is also advancing cell therapies, bispecific antibodies, and antibody-drug conjugates, positioning itself at the forefront of cancer treatment innovation.

Partnerships play a crucial role in BioNTech's strategy. The company collaborates with major pharmaceutical giants such as Roche, Eli Lilly, Pfizer, Sanofi, and Genmab, leveraging shared expertise to accelerate the development and commercialization of its therapies. Recent strategic collaborations include an agreement with MediLink Therapeutics to utilize their TMALIN® antibody-drug conjugate platform, enhancing BioNTech's capabilities in targeting novel cancer therapeutics.

BioNTech's financial health is robust, bolstered by the commercial success of Comirnaty and ongoing strategic partnerships. The company's commitment to innovation and excellence is reflected in its continuous efforts to develop new therapeutics and vaccines, ensuring significant contributions to global healthcare.

For more detailed information, visit the company's official website at www.BioNTech.com.

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Pfizer and BioNTech announced that the FDA granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 to 11. The CDC's recommendation is pending before shipping. This booster aims to enhance protection as Omicron subvariants dominate U.S. cases. A clinical trial is underway for younger children. The companies have also applied for regulatory approvals in Europe and plan global submissions. Eligible residents will receive vaccines for free under U.S. government provisions.

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BioNTech has partnered with Australia's State of Victoria to establish an mRNA research and innovation center in Melbourne, enhancing translational research for innovative medicines. A BioNTainer facility for clinical-scale manufacturing of mRNA products will also be constructed. BioNTech aims to expand its clinical development efforts in Australia, targeting cancer product candidates including BNT211, alongside two Phase 2 candidates currently in trials. The partnership will promote mRNA technology accessibility and collaboration in the Asia-Pacific region.

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Pfizer and BioNTech announced on September 26, 2022, the submission of a request to the U.S. FDA for Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine targeted at children aged 5 to 11. The request is bolstered by safety and immunogenicity data from previous vaccine trials. Additionally, a Phase 1/2/3 study has commenced to assess different dosing regimens in children aged 6 months to 11 years. A marketing authorization extension for the vaccine in the EU is also planned.

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Pfizer (PFE) and BioNTech (BNTX) announced the submission of a request to the FDA for Emergency Use Authorization of a 10-µg booster dose of their bivalent COVID-19 vaccine targeting the Omicron BA.4/BA.5 variant for children aged 5-11. This request is backed by safety and immunogenicity data. Additionally, a Phase 1/2/3 study has been initiated to evaluate the vaccine's safety and immune response among children aged 6 months to 11 years. The companies also plan to submit a marketing authorization application to the EMA for the same age group.

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BioNTech and Pfizer announced a significant advancement for their COVID-19 vaccine, COMIRNATY. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended converting the conditional Marketing Authorization (cMA) to a full Marketing Authorization (MA) for all existing indications and formulations. This includes the bivalent variants. Additionally, the CHMP supported a booster dose for children aged 5 to 11 years. The European Commission will make the final decision, pending review of the recommendation.

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Pfizer and BioNTech have received a conditional marketing authorization recommendation from the EMA's CHMP for their Omicron BA.4/BA.5 bivalent COVID-19 vaccine. This vaccine combines 15-µg of mRNA from the original SARS-CoV-2 strain and 15-µg from the Omicron BA.4/BA.5 variants, targeting individuals aged 12 and older. Pending approval from the European Commission, the vaccine will be available for EU vaccination campaigns this fall, enhancing immunity against the Omicron variant. Previous studies showed a strong immune response and favorable safety profile for the vaccine.

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Pfizer and BioNTech have received a conditional marketing authorization recommendation from the EMA's CHMP for their bivalent Omicron BA.4/BA.5 COVID-19 vaccine for individuals 12 years and older. The vaccine combines components targeting both the original SARS-CoV-2 and Omicron subvariants, designed to elicit a strong immune response. If approved by the European Commission, distribution will commence immediately to support EU vaccination efforts this fall. Previous data showed a superior immune response against Omicron subvariants compared to the existing vaccine.

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BioNTech has reported positive follow-up results from its Phase 1/2 trial of BNT211, a CAR-T cell therapy targeting advanced solid tumors, including testicular cancer. The results showed a 57% overall response rate and an 85% disease control rate in testicular cancer patients treated with the higher dose after lymphodepletion. Notably, BNT211 has received Priority Medicines designation from the European Medicines Agency, emphasizing its potential as a treatment option. The safety profile remains manageable, with no serious adverse effects reported.

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BioNTech (Nasdaq: BNTX) announced a visit by CEO Prof. Ugur Sahin to Israel on September 7, 2022, to discuss potential collaborations on pandemic preparedness and innovative medicine development. Meetings included officials from the Ministry of Economy and Industry and key academic leaders. The talks focused on establishing a research facility and leveraging Israeli technologies for vaccine production. Prof. Sahin lauded Israel's public health initiatives. The discussions were facilitated by various governmental bodies and are aimed at enhancing BioNTech's international partnerships.

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FAQ

What is the current stock price of BioNTech SE American Depositary Share (BNTX)?

The current stock price of BioNTech SE American Depositary Share (BNTX) is $113.51 as of December 23, 2024.

What is the market cap of BioNTech SE American Depositary Share (BNTX)?

The market cap of BioNTech SE American Depositary Share (BNTX) is approximately 27.1B.

What does BioNTech SE do?

BioNTech SE is a biotechnology company focused on developing cancer immunotherapies and vaccines for infectious diseases, including COVID-19.

Where is BioNTech SE based?

BioNTech SE is based in Germany.

What is BioNTech's most well-known product?

BioNTech's most well-known product is the COVID-19 vaccine, Comirnaty, developed in collaboration with Pfizer.

Who are BioNTech's major partners?

BioNTech collaborates with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab.

What types of cancer therapies is BioNTech developing?

BioNTech is developing a variety of cancer therapies, including mRNA-based drugs, cell therapies, bispecific antibodies, and antibody-drug conjugates.

What is the TMALIN® platform?

The TMALIN® platform is an antibody-drug conjugate technology developed by MediLink Therapeutics, used by BioNTech for cancer therapeutics.

How can investors find more information about BioNTech?

Investors can find more information on BioNTech's official website or by contacting their investor relations team.

What recent collaboration has BioNTech announced?

BioNTech recently announced a strategic collaboration with MediLink Therapeutics to use their TMALIN® antibody-drug conjugate platform for novel cancer targets.

What is BioNTech's role in the fight against COVID-19?

BioNTech developed the COVID-19 vaccine Comirnaty in collaboration with Pfizer, which has become a critical tool in combating the pandemic.

Where can I find BioNTech's latest news and updates?

BioNTech's latest news and updates can be found on their official website and through their media relations contacts.

BioNTech SE American Depositary Share

NYSE:BNTX

BNTX Rankings

BNTX Stock Data

27.08B
91.82M
61.66%
20.63%
1.03%
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