This section highlights FDA-related milestones and regulatory updates for drugs developed by BioNTech (BNTX).
Over the past two years, BioNTech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BNT111, BNT165e, BNT211, BNT326/YL202, BNT327, COMIRNATY®, and DB-1311. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BNT111 + Libtayo (cemiplimab) - FDA Regulatory Timeline and Events
BNT111 + Libtayo (cemiplimab) is a drug developed by BioNTech for the following indication: Anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BNT111 + Libtayo (cemiplimab)
- Announced Date:
- July 30, 2024
- Indication:
- Anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma
Announcement
BioNTech SE 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.
AI Summary
BioNTech SE announced positive topline results from an ongoing Phase 2 trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease progressed following anti-PD-(L)1 treatment. The study evaluated the mRNA immunotherapy BNT111 in combination with cemiplimab. Results showed that the combination met its primary endpoint, demonstrating a statistically significant improvement in overall response rate (ORR) compared to historical controls. Both BNT111 monotherapy and cemiplimab monotherapy arms also exhibited clinical activity, with cemiplimab’s ORR aligning with historical data. BNT111 leverages BioNTech’s FixVac platform, which is designed to stimulate a targeted immune response against melanoma-associated antigens. The company plans to present additional data at an upcoming medical conference and aims to publish the findings, marking a key step forward in mRNA-based immunotherapy for treatment-resistant melanoma.
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BNT165e - FDA Regulatory Timeline and Events
BNT165e is a drug developed by BioNTech for the following indication: for prevention of P. falciparum malaria in healthy malaria-naive adults.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BNT165e
- Announced Date:
- March 5, 2025
- Indication:
- for prevention of P. falciparum malaria in healthy malaria-naive adults.
Announcement
BioNTech announced that The U.S. Food and Drug Administration (“FDA”) has informed BioNTech SE (“BioNTech”) that it has placed a clinical hold on BioNTech’s Investigational New Drug application (“IND”) and the related Phase I/IIa clinical trial (NCT06069544) evaluating the safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.
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BNT211 - FDA Regulatory Timeline and Events
BNT211 is a drug developed by BioNTech for the following indication: For treatment of Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BNT211
- Announced Date:
- September 5, 2024
- Indication:
- For treatment of Advanced Solid Tumors
Announcement
BioNTech SE will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology ("ESMO") Congress 2024 in Barcelona, Spain from September 13-17, 2024.
AI Summary
BioNTech SE will showcase clinical trial data from its multi-platform oncology pipeline at the ESMO Congress 2024 in Barcelona, Spain, taking place from September 13–17, 2024. The presentations will include both oral and poster sessions that highlight new progress in mRNA-based cancer vaccines, next-generation immunomodulators, and targeted therapy approaches. Prof. Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech, emphasized the potential of combining treatment modalities to improve cancer care. At the congress, the company will detail findings from three clinical trials focusing on BNT327/PM8002, a bispecific antibody that forms a key component of their combination treatment strategy. Additional clinical data will support the proof of concept of BioNTech’s mRNA-based FixVac approach, which targets non-mutated tumor-associated antigens and has shown early signs of clinical activity for various cancer indications.
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BNT326/YL202 - FDA Regulatory Timeline and Events
BNT326/YL202 is a drug developed by BioNTech for the following indication: For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BNT326/YL202
- Announced Date:
- August 15, 2024
- Indication:
- For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer
Announcement
MediLink and BioNTech SE announced that The FDA has lifted the partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC).
Read Announcement- Drug:
- BNT326/YL202
- Announced Date:
- June 17, 2024
- Indication:
- For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer
Announcement
BioNTech SE has been informed by its partner MediLink Therapeutics (Suzhou) Co., Ltd that the U.S. Food and Drug Administration (“FDA”) has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate (“ADC”) product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) or HR+/HER2-negative breast cancer.
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BNT327 - FDA Regulatory Timeline and Events
BNT327 is a drug developed by BioNTech for the following indication: In small-cell lung cancer and in triple-negative breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BNT327
- Announced Date:
- June 2, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
BioNTech and Bristol Myers Squibb announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech's investigational bispecific antibody BNT327 across numerous solid tumor types.
AI Summary
BioNTech and Bristol Myers Squibb have announced a global partnership to co-develop and co-commercialize BioNTech’s investigational bispecific antibody BNT327 for various solid tumor types. BNT327, which targets both PD-L1 and VEGF-A, is designed to boost the immune system’s ability to fight cancer while also hindering tumor blood vessel growth. The companies will share profits and losses equally and combine their expertise and resources to accelerate the clinical development and potential regulatory approvals of this innovative therapy. With over 1,000 patients already treated across several trials, BNT327 is currently being evaluated as a standalone treatment and in combination with other therapies. This strategic collaboration aims to expand treatment options and potentially set a new standard of care in oncology by addressing a broad range of solid tumors.
Read Announcement- Drug:
- BNT327
- Announced Date:
- April 24, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
BioNTech SE announced that it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025.
AI Summary
BioNTech SE announced plans to present select data from its diversified oncology pipeline at the AACR Annual Meeting in Chicago from April 25‑30, 2025. The company will highlight advances in mRNA cancer immunotherapies, next‑generation immunomodulators, and targeted therapies. A key focus will be on early data for combining its PD‑L1xVEGF‑A bispecific antibody candidate with antibody‑drug conjugates (ADCs) to enhance antitumor effects.
Prof. Özlem Türeci, Co‑Founder and Chief Medical Officer, emphasized that combining novel immuno‑oncology approaches could set a future standard for advanced cancer treatment. The data presentations are designed to showcase BioNTech’s strategy of integrating complementary mechanisms to drive synergistic antitumor activity and improve patient outcomes, marking another significant step in the company’s efforts to innovate within the oncology field.
Read Announcement- Drug:
- BNT327
- Announced Date:
- March 10, 2025
- Indication:
- In small-cell lung cancer and in triple-negative breast cancer
Announcement
BioNTech SE provided an update on its corporate progress.
AI Summary
BioNTech SE provided a corporate progress update focusing on its expanding oncology pipeline. The company has strengthened its development of next-generation immunomodulators with candidate BNT327, a bispecific antibody that targets PD-L1 and VEGF-A. With the completion of its acquisition of Biotheus, BioNTech secured full control of BNT327 and related assets, setting the stage for several ongoing Phase 2 and Phase 3 clinical trials in various cancers such as small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer.
Looking ahead, BioNTech expects key data readouts in 2025 and 2026 that could provide clinical proof for its oncology strategy, aiming to become a diversified multi-product oncology portfolio company by 2030. The company’s strong financial position and significant R&D investments further support its long-term vision for transforming cancer treatment.
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COMIRNATY® JN.1 - FDA Regulatory Timeline and Events
COMIRNATY® JN.1 is a drug developed by BioNTech for the following indication: monovalent COVID-19 vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COMIRNATY® JN.1
- Announced Date:
- June 27, 2024
- Indication:
- monovalent COVID-19 vaccine
Announcement
Pfizer Inc and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies' Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
AI Summary
Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY® JN.1. This updated vaccine is designed to protect individuals aged 6 months and older from COVID-19 caused by the SARS‑CoV‑2 virus, specifically targeting the emerging Omicron JN.1 variant and its sublineages.
The recommendation is based on pre-clinical and epidemiological data, which showed that the JN.1-adapted vaccine produces an improved immune response compared to previous formulations. Once the European Commission grants final authorization, doses will be ready for immediate shipment to applicable EU member states, ensuring swift availability as the vaccination campaign for the 2024-2025 season ramps up.
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DB-1311 - FDA Regulatory Timeline and Events
DB-1311 is a drug developed by BioNTech for the following indication: For the treatment of patients with advanced/unresectabl.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DB-1311
- Announced Date:
- June 24, 2024
- Indication:
- For the treatment of patients with advanced/unresectabl
Announcement
BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. announced that the U.S. Food and Drug Administration ("FDA") granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer ("CRPC") who have progressed on or after standard systemic regimens.
AI Summary
BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. recently announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for their ADC candidate BNT324/DB-1311. The drug is being developed to treat advanced, unresectable, or metastatic castration-resistant prostate cancer (CRPC) in patients who have progressed after standard treatments. Early studies, including preclinical data and results from an ongoing Phase 1/2 trial, have shown promising antitumor activity and a manageable safety profile in patients with advanced solid tumors. This Fast Track status allows the companies to have more frequent interactions with the FDA, potentially speeding up development and regulatory review. BioNTech and Duality Biologics are optimistic that their targeted ADC, which focuses on the immune checkpoint protein B7-H3, could improve outcomes for patients with advanced CRPC.
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mRNA vaccine - FDA Regulatory Timeline and Events
mRNA vaccine is a drug developed by BioNTech for the following indication: Against influenza and COVID-19 in healthy individuals 18-64 years of age.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA vaccine
- Announced Date:
- August 16, 2024
- Indication:
- Against influenza and COVID-19 in healthy individuals 18-64 years of age.
Announcement
Pfizer Inc. and BioNTech SE announced top-line results from their Phase 3 clinical trial to evaluate the companies' combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age.
AI Summary
Pfizer Inc. and BioNTech SE recently announced top-line results from their Phase 3 clinical trial evaluating a combined mRNA vaccine candidate for both influenza and COVID-19 in healthy individuals aged 18-64. In this study, which involved more than 8,000 participants, the vaccine met one of its two primary immunogenicity goals. It produced comparable immune responses against COVID-19 and robust responses to influenza A when compared to standard vaccines. However, the candidate did not meet the non-inferiority goal for the influenza B strain. The companies are now considering adjustments to enhance the vaccine’s effectiveness against influenza B and will discuss next steps with health authorities. No safety concerns have been reported in the ongoing data review, highlighting a positive direction for the development of an efficient combination vaccine.
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Omicron KP.2 - FDA Regulatory Timeline and Events
Omicron KP.2 is a drug developed by BioNTech for the following indication: For Omicron KP.2-adapted COVID-19 Vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Omicron KP.2
- Announced Date:
- August 22, 2024
- Indication:
- For Omicron KP.2-adapted COVID-19 Vaccine
Announcement
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration ("FDA") has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine.
AI Summary
Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for COMIRNATY® (COVID-19 Vaccine, mRNA) for individuals 12 years and older. The FDA also granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for children 6 months to 11 years old. This updated vaccine is designed to protect against the Omicron KP.2 strain and is the preferred approach for the 2024-2025 fall and winter season, following FDA guidance. For most people 5 years and older, the vaccine is administered as a single dose. The decision is backed by extensive clinical, non-clinical, and real-world evidence showing that the updated formulation elicits a strong immune response and improved protection against emerging strains. Shipping has already begun to ensure widespread availability in pharmacies, hospitals, and clinics nationwide.
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