Announced positive data from multiple mRNA cancer vaccine clinical trials, including topline results from the ongoing Phase 2 evaluating FixVac candidate BNT111 Launched updated variant-adapted COVID-19 vaccine in the European Union ("EU"), received approval in the United Kingdom and initiated rolling supplemental Biologics Licensing Application ("sBLA") with the United States Food and Drug Administration ("U.S. FDA") Reiterates guidance for total revenues in the range of €2.5-3.1 billion Reports second qua ...

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. About BioNTech To access the live conference call via telephone, please register via ...

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Onc ...

2 European Medicines Agency (EMA) ETF recommends updating COVID-19 vaccines to target new JN.1 variant. 30 April 2024. Available at: https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19- vaccines-target-new-jn1-variant (Accessed 26.06.2024). BioNTech: Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de Investor Relations Victoria Meissner, M.D. +1 617 528 8293 Investors@biontech.de ---------- 1 World Health Organization (WHO) Statement on the antigen composition of COVID-1 ...

Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2 With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration ("FDA") to support development and expedite regulatory review Prostate cancer is the second ...

COPENHAGEN, Denmark, and MAINZ, Germany, June 1, 2024 — Genmab A/S (NASDAQ:GMAB, "Genmab"))) and BioNTech SE (NASDAQ:BNTX, "BioNTech"))) today announced initial data from the ongoing Phase 2 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PD-L(1)-positive metastatic non-small cell lung cancer ("mNSCLC") who had disease progression following one or more ...

Core Insights - MediLink Therapeutics has announced a strategic collaboration with BioNTech, granting BioNTech an exclusive option for a global license to MediLink's TMALIN® antibody-drug conjugate (ADC) platform for several novel targets [1][2] Group 1: Collaboration Details - MediLink will receive an upfront payment of $25 million and could earn up to $1.8 billion in additional milestone payments, along with tiered royalties on future global annual net sales [2] - MediLink retains the right of first negotiation for future collaborations regarding these ADC product candidates in the Mainland China market and potentially in Hong Kong, Macau, or Taiwan [2] Group 2: Previous Collaborations - The new agreement expands upon a previous collaboration established in October 2023, where MediLink and BioNTech entered into a global license agreement to develop BNT326/YL202, a next-generation anti-HER3 ADC [3] Group 3: Company Overview - MediLink Therapeutics, founded in 2020, focuses on developing conjugated drugs with global competitiveness and has developed the proprietary TMALIN® ADC technology platform [4] - The TMALIN® platform enables the creation of homogeneous ADCs with a high drug-antibody ratio and improved therapeutic window for solid tumors, addressing unmet medical needs [4][5]

A bird flu outbreak could spur demand for vaccines from these key players, but is it likely? Shares of vaccine stocks Moderna (MRNA 0.42%), Novavax (NVAX -3.50%), and BioNTech SE (BNTX -3.23%) rallied this week, appreciating 23.4%, 16.4%, and 9.3%, respectively, through Thursday trading, according to data from S&P Global Market Intelligence. Unlike the COVID-19 pandemic, when the U.S. government subsidized private companies to make the COVID- 19 vaccine, the government actually has a stockpile of H5N1 virus ...