Biontech SE（BNTX）資訊與事件

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BNTX 資訊

9.510-18Fool

BioNTech Faces Setbacks in Clinical Trials Amid Pipeline Hopes

7.510-17Fool

BioNTech's Cash Reserves and Promising Cancer Pipeline Signal Growth Potential

7.010-14PRnewswire

BioNTech's AHEAD-MERIT Trial Misses Key Endpoint, Investors Face Losses

2.010-14stocktwits

BioNTech's mRNA Cancer Therapy Faces Setbacks

9.010-13stocktwits

BioNTech's Cancer Trial Results Disappoint

6.510-13Fool

Moderna vs BioNTech: Diverging Market Performances

8.510-10stocktwits

National Cancer Vaccine Initiative Launches

8.510-08Fool

BioNTech Transitions to Multi-Product Oncology Company

9.510-03Fool

Bristol Myers Squibb Shares Surge 42% Amid Patent Challenges

9.509-28Fool

Moderna vs BioNTech: Cancer Therapy Comparison

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BNTX 事件

10/22 07:00

BioNTech Collaborates with Gilead on Clinical Trial

BioNTech (BNTX) announced a clinical trial collaboration and supply agreement with Gilead Sciences (GILD) to evaluate pumitamig in combination with the TROP2-directed antibody-drug conjugate sacituzumab govitecan as first-line treatment for patients with locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer. Pumitamig is an investigational bispecific immunomodulator designed to cooperatively bind to PD-L1 and VEGF-A that is being jointly developed by BioNTech and Bristol Myers Squibb (BMY). Under the terms of the agreement, BioNTech will continue to sponsor and lead the ROSETTA Breast-01 trial. Gilead will supply sacituzumab govitecan for the combination trial.

10/13 07:00

BioNTech AHEAD-MERIT Trial Fails to Meet Primary Endpoint

BioNTech reports AHEAD-MERIT trial did not meet first dual primary endpoint

10/13 07:00

BioNTech Announces Topline Results from AHEAD-MERIT Trial

BioNTech announced the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial for its investigational mRNA cancer immunotherapy BNT113, tenu-ra. The clinical trial is evaluating BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic human papillomavirus 16-positive, or HPV16+, head and neck squamous cell carcinoma, or HNSCC, expressing PD-L1. Approximately one third of HNSCC cases are associated with HPV infection. The Phase 3 part of AHEAD-MERIT has dual primary endpoints, progression-free survival and overall survival. At the analysis for PFS, BNT113 in combination with pembrolizumab did not demonstrate a statistically significant improvement in PFS versus pembrolizumab alone. The Independent Data Monitoring Committee has recommended that the clinical trial continues as planned to evaluate the second primary endpoint of OS. Under the trial's pre-specified statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome, even if the PFS dual primary endpoint was not met.

10/9 14:30

New Cancer Vaccine Initiative Inspired by COVID Model Launches in December

New details have emerged about a new initiative the starts in December to fast-track cancer vaccines, in which a planned public-private partnership involving the National Institutes of Health, the nonprofit foundation for the NIH, researchers, pharmaceutical and biotech companies, advocacy groups, philanthropies, and patients all working together to work on and test the vaccines, the New York Times' Gina Kolata reports. "We can do things that would not otherwise be done," Dr. Anthony Letai, director of the National Cancer Institute, said of new resources being made available the National Institutes of Health. "We can place big bets on new ideas." "We hope this will be like Covid vaccines," said Stacey Adam, a senior clinical officer at the Foundation for the NIH. The vaccine program is expected to start in December, beginning with a focus on pancreatic cancer, liver cancer, and colorectal cancer, the author notes. Shares of Moderna (MRNA) surged 13.1% after the news, while other pharma and vaccine stocks also traded higher, including Pfizer (PFE), Johnson & Johnson (JNJ), Merck (MRK), Novavax (NVAX), AstraZeneca (AZN), and BioNTech (BNTX).

9/17 14:00

Pfizer Canada and BioNTech Authorized for XFG Variant Vaccine

Pfizer Canada (PFE) and BioNTech (BNTX) announced that Health Canada has authorized the XFG variant-adapted COMIRNATY for active immunization of individuals aged 6 months and older against COVID-19. The updated COMIRNATY vaccine targets the Omicron XFG lineage, in alignment with public health recommendations for the 2026-2027 season. The Health Canada approval is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY. The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, other countries, and the holder of emergency use authorizations or equivalents in other countries.

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