BIONTECH Stock Price, News & Analysis

Pfizer (NYSE:PFE) and BioNTech have announced positive topline results from their Phase 3 clinical trial of the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula. The study involved 100 participants, including adults aged 65+ and those 18-64 with risk conditions for severe COVID-19.

The trial demonstrated that 14 days post-vaccination, participants showed at least a 4-fold increase in LP.8.1-neutralizing antibody titers compared to pre-vaccination levels. The safety profile remained consistent with previous studies, with no new safety concerns identified.

These findings support the recent FDA approval of the LP.8.1-adapted COVID-19 vaccine and reinforce its potential effectiveness against multiple circulating SARS-CoV-2 sublineages.

BioNTech (NASDAQ:BNTX) and Pfizer have received FDA approval for their LP.8.1-adapted monovalent COVID-19 vaccine COMIRNATY® for adults 65 and older, and individuals 5-64 years with high-risk conditions. The 2025-2026 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, selected based on FDA guidance to better match circulating strains.

Pre-clinical data shows the vaccine generates improved immune responses against multiple SARS-CoV-2 sublineages, including XFG and NB.1.8.1, compared to previous JN.1 and KP.2-adapted versions. Immediate shipping will begin to ensure widespread availability across U.S. pharmacies, hospitals, and clinics.

To date, 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, maintaining a favorable safety and efficacy profile supported by extensive real-world evidence.

BioNTech (NASDAQ:BNTX) reported Q2 2025 financial results and significant strategic developments. The company recorded revenues of €260.8 million and a net loss of €386.6 million (€1.60 per share). Key highlights include a major collaboration with Bristol Myers Squibb for BNT327 development, featuring a $1.5 billion upfront payment and potential milestone payments up to $7.6 billion.

The company maintains a strong financial position with €16.0 billion in cash and investments. BioNTech reaffirmed its 2025 revenue guidance of €1.7-2.2 billion. The company received approval for a new variant-adapted COVID-19 vaccine in Europe, with deliveries expected to begin in August 2025.

Strategic developments include the announced acquisition of CureVac and advancement of oncology programs, particularly in pan-tumor treatments. R&D expenses were €509.1 million for Q2 2025, showing the company's continued investment in pipeline development.

BioNTech (NASDAQ:BNTX) and Pfizer have received a positive CHMP opinion for their LP.8.1-adapted COVID-19 vaccine in the European Union. The updated vaccine demonstrates improved immune response against dominant variants including XFG and NB.1.8.1 compared to 2024-2025 formulations.

Upon European Commission authorization, the vaccine will be available for individuals 6 months and older. The companies have already initiated manufacturing to ensure supply readiness for the upcoming fall/winter season, with doses ready to ship immediately following EC approval.

The recommendation is supported by comprehensive clinical, non-clinical, and real-world data, with over a billion doses administered globally demonstrating favorable safety and efficacy profiles.

BioNTech (NASDAQ: BNTX) has scheduled its second quarter 2025 financial results announcement and corporate update for August 4, 2025. The company will host a conference call and webcast at 8:00 a.m. EDT (2:00 p.m. CEST) on the same day.

Investors and analysts can access the conference call via telephone by registering through a provided link, which will supply dial-in numbers and a PIN. The presentation slides and webcast will be accessible through the company's website, with a replay available for 30 days after the event.

BioNTech (NASDAQ: BNTX) announced that Chief Strategy Officer Ryan Richardson will step down from the Management Board effective September 30, 2025. Richardson, who joined in 2018 and served as CSO since January 2020, played a crucial role in the company's development, including raising over $1 billion in capital through Series B financing, IPO, and follow-on offerings.

During his tenure, Richardson led Global Strategy and Corporate Development functions, overseeing more than a dozen collaborations and acquisitions. He also managed Capital Markets and Investor Relations, expanding analyst coverage and strengthening BioNTech's global shareholder base. His responsibilities will be transitioned to other Management Board members to ensure a smooth handover.

BioNTech SE (Nasdaq: BNTX) reported Q1 2025 financial results with revenues of €182.8 million, primarily driven by COVID-19 vaccine collaboration. The company posted a net loss of €415.8 million and loss per share of €1.73. Despite losses, BioNTech maintains a strong financial position with €15.9 billion in cash and investments.

Key highlights include advancement in oncology pipeline, particularly BNT327 (PD-L1xVEGF-A bispecific antibody) and mRNA cancer immunotherapies. The company confirmed its 2025 revenue guidance of €1.7-2.2 billion and announced preparation for 2025/2026 variant-adapted COVID-19 vaccine.

BioNTech (BNTX) announced a strategic all-stock acquisition of CureVac in a deal valued at approximately $1.25 billion. Under the agreement, each CureVac share will be exchanged for $5.46 in BioNTech ADSs, representing a 55% premium to CureVac's three-month volume weighted average price. The acquisition aims to strengthen BioNTech's oncology strategy by combining both companies' mRNA capabilities in research, development, manufacturing, and commercialization of cancer immunotherapy candidates. The transaction, expected to close in 2025, has received unanimous approval from both companies' boards and support from CureVac's major shareholders, representing 50.08% of shares. Upon closing, CureVac shareholders will own between 4-6% of BioNTech, and CureVac's operating subsidiary will become wholly owned by BioNTech, including its Tübingen research and manufacturing site.

BioNTech and Bristol Myers Squibb have announced a major global strategic partnership to co-develop and co-commercialize BNT327, a next-generation bispecific antibody targeting PD-L1 and VEGF-A for multiple solid tumor types. BMS will pay BioNTech $1.5B upfront, $2B in non-contingent payments through 2028, and up to $7.6B in additional milestones. The companies will share development costs and profits/losses 50:50. BNT327 is currently in multiple trials with over 1,000 patients, including Phase 3 trials for small cell lung cancer and non-small cell lung cancer, with a planned Phase 3 trial for triple negative breast cancer starting by end of 2025. The collaboration aims to accelerate BNT327's development and potential regulatory approvals, leveraging both companies' expertise in immuno-oncology.