BioNTech SE American Depositary Share - BNTX STOCK NEWS

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.

BioNTech and CEPI are expanding their partnership to bolster Africa's mRNA vaccine capabilities. CEPI will provide up to $145 million to support BioNTech in Kigali, Rwanda, enhancing the facility's R&D and manufacturing capacities. This initiative aims to prepare Africa for future epidemic threats and ensure equitable vaccine access, with a focus on affordable pricing for low and middle-income countries. BioNTech plans to produce mRNA vaccines for diseases like malaria, mpox, and tuberculosis, dedicating up to 50% of its production capacity for emergency response during outbreaks. The collaboration will also support local research and development efforts to strengthen the broader African vaccine ecosystem.

MediLink Therapeutics has announced a strategic collaboration with BioNTech, granting BioNTech exclusive global rights to MediLink's TMALIN® ADC technology for several targets. BioNTech will pay $25 million upfront, with potential milestone payments up to $1.8 billion and tiered royalties on future sales. MediLink retains negotiation rights for exclusive licensing in Mainland China and adjacent regions. This expands their partnership, initially formed in October 2023, to develop the anti-HER3 ADC BNT326/YL202, reaffirming their collaborative efforts in the ADC arena.