BIONTECH Stock Price, News & Analysis

Tempus AI (NASDAQ: TEM) has announced a multi-year collaboration with BioNTech SE (Nasdaq: BNTX) to enhance BioNTech's next-generation oncology pipeline. The partnership leverages Tempus' large multimodal datasets and computational biology expertise to support BioNTech's research and development efforts in oncology.

Tempus will provide analytical support and access to its real-world multimodal database to help BioNTech generate novel insights into biological mechanisms. This collaboration aims to advance the discovery of new therapies and enhance the development of BioNTech's clinical oncology pipeline. The partnership combines Tempus' real-world data and computational technology with BioNTech's AI capabilities and multi-platform discovery engine to potentially bring innovative therapies to cancer patients.

Pfizer and BioNTech have received FDA approval and authorization for their Omicron KP.2-adapted COVID-19 vaccine for the 2024-2025 season. The vaccine is approved for individuals 12 years and older and authorized for emergency use in children 6 months to 11 years. It's designed to target the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage, as recommended by the FDA for the upcoming fall and winter season. The vaccine will be available as a single dose for most individuals 5 years and older, with additional doses for certain immunocompromised individuals or young children. Immediate shipping has begun to ensure widespread availability across the U.S. in the coming days.

Pfizer and BioNTech have provided an update on their mRNA-based combination vaccine program against influenza and COVID-19 for individuals aged 18-64. In a Phase 3 trial, the vaccine candidate met one of its two primary immunogenicity objectives. The trial showed robust influenza A responses and comparable COVID-19 responses versus comparator vaccines. However, it did not meet the non-inferiority objective against the influenza B strain.

Additionally, Pfizer reported encouraging data from a separate Phase 2 trial of its second-generation trivalent influenza mRNA vaccine, demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine. The companies are evaluating adjustments to the combination vaccine candidate and will discuss next steps with health authorities.

BioNTech announced its second quarter 2024 financial results, revealing a net loss of €807.8 million and revenues of €128.7 million, down from the previous year's €167.7 million. The company is investing heavily in R&D, spending €525.6 million, primarily on oncology and non-COVID-19 mRNA projects. BioNTech launched an updated COVID-19 vaccine in the EU, received UK approval, and initiated a rolling sBLA with the U.S. FDA.

Key clinical developments include positive Phase 2 results for cancer vaccine BNT111 and the commencement of trials for novel drug combinations. Despite the financial loss, BioNTech holds a strong cash position of €18.5 billion.

The company reiterates its 2024 revenue guidance of €2.5-3.1 billion. R&D expenses for the full year are projected between €2.4-2.6 billion, with SG&A expenses between €700-800 million. BioNTech continues to target long-term growth in oncology and infectious diseases.

BioNTech (BNTX) announced positive topline results from its Phase 2 trial of BNT111, an mRNA immunotherapy for advanced melanoma. The trial met its primary endpoint, showing a statistically significant improvement in overall response rate (ORR) when BNT111 was combined with cemiplimab, compared to historical control in anti-PD-(L)1 relapsed/refractory patients. Both monotherapy arms also showed clinical activity. The treatment was well-tolerated, with a safety profile consistent with previous trials.

BNT111, based on BioNTech's FixVac platform, received Fast Track and Orphan Drug designations from the FDA in 2021. The company plans to present detailed data at an upcoming medical conference and submit for peer-reviewed publication.

BioNTech SE (Nasdaq: BNTX) has announced that it will release its second quarter 2024 financial results on Monday, August 5, 2024. The company will also host a conference call and webcast on the same day at 8:00 a.m. EDT (2:00 p.m. CEST) to discuss the financial results and provide a corporate update.

Investors, financial analysts, and the general public can access the live conference call via telephone by registering through a provided link. The slide presentation and audio of the webcast will be available through another link. Participants can also access the materials via the 'Events & Presentations' page in the Investor Relations section of BioNTech's website. A replay of the webcast will be archived on the company's website for 30 days following the call.

Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY JN.1. This vaccine, targeting the Omicron JN.1 lineage of SARS-CoV-2, is recommended for individuals aged 6 months and older. The decision follows pre-clinical and epidemiological data indicating an improved immune response against multiple JN.1 sublineages.

Upon authorization by the European Commission, doses will be ready to ship to EU member states. The CHMP’s recommendation is supported by extensive clinical and real-world evidence demonstrating the vaccine's safety and efficacy. This follows recent FDA guidance to adapt vaccines to target the Omicron KP.2 subvariant, with the companies starting rolling applications for approval in the U.S.

BioNTech and DualityBio's BNT324/DB-1311, an antibody-drug conjugate (ADC) targeting B7-H3, has received FDA Fast Track designation for treating advanced/metastatic castration-resistant prostate cancer (CRPC). This designation, based on preclinical and Phase 1/2 clinical data demonstrating antitumor activity and a manageable safety profile, facilitates more frequent FDA interactions and expedited regulatory review. CRPC patients, who often face poor prognosis with a 5-year survival rate of 36%, may benefit from this development. All three ADC candidates under BioNTech-DualityBio collaboration have now received FDA Fast Track designation, indicating the promise of their ADC technology.

In a Phase 2 trial, Genmab and BioNTech's investigational antibody, acasunlimab, combined with pembrolizumab showed promising results for patients with PD-L1-positive metastatic non-small cell lung cancer (mNSCLC). The trial reported a 12-month overall survival (OS) rate of 69% and a median OS of 17.5 months. A 30% overall response rate was observed in patients receiving the combination every six weeks. The study's findings will inform a planned Phase 3 trial expected to start by the end of 2024. Adverse events were mostly mild and manageable, with a lower incidence of severe events in the six-week treatment group.